The Ecofisio Mobile App for Assessment and Diagnosis Using Ultrasound Imaging for Undergraduate Health Science Students: Multicenter Randomized Controlled Trial

Background Generation Z is starting to reach college age. They have adopted technology from an early age and have a deep dependence on it; therefore, they have become more drawn to the virtual world. M-learning has experienced huge growth in recent years, both in the medical context and in medical and health sciences education. Ultrasound imaging is an important diagnosis technique in physiotherapy, especially in sports pathology. M-learning systems could be useful tools for improving the comprehension of ultrasound concepts and the acquisition of professional competencies. Objective The purpose of this study was to evaluate the efficacy and use of an interactive platform accessible through mobile devices—Ecofisio—using ultrasound imaging for the development of professional competencies in the evaluation and diagnosis of sports pathologies. Methods Participants included 110 undergraduate students who were placed into one of two groups of a randomized controlled multicenter study: control group (ie, traditional learning) and experimental group (ie, Ecofisio mobile app). Participants’ theoretical knowledge was assessed using a multiple-choice questionnaire (MCQ); students were also assessed by means of the Objective Structured Clinical Examination (OSCE). Moreover, a satisfaction survey was completed by the students. Results The statistical analyses revealed that Ecofisio was effective in most of the processes evaluated when compared with the traditional learning method: all OSCE stations, P<.001; MCQ, 43 versus 15 students passed in the Ecofisio and control groups, respectively, P<.001. Moreover, the results revealed that the students found the app to be attractive and useful. Conclusions The Ecofisio mobile app may be an effective way for physiotherapy students to obtain adequate professional competencies regarding evaluation and diagnosis of sports pathologies. Trial Registration ClinicalTrials.gov NCT04138511; https://clinicaltrials.gov/ct2/show/NCT04138511

Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) 16258 1a) Does your paper address CONSORT item 1a? * Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if oqine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study "...The EcoPsio Mobile App..."

1a-ii) Non-web-based components or impo"ant co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study ...Ultrasound Imaging for Undergraduate Health Science Students:... Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Participants included 110 undergraduate students who were placed into one of two groups of a randomized controlled multicenter study: control group (ie, traditional learning) and experimental group (ie, EcoPsio mobile app). Participants' theoretical knowledge was assessed using a multiple-choice questionnaire (MCQ); students were also assessed by means of the Objective Structured Clinical Examination (OSCE). Moreover, a satisfaction survey was completed by the students.

1b-ii) Level of human involvement in the METHODS section of the ABSTRACT
Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 5/3/20 18:17 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Página 13 de 57 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. oqine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials Does your paper address subitem 1b-iii? Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Page 1, Introduction, last paragraph 5/3/20 18:17 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Página 17 de 57 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Impo"ant changes to methods a#er trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study We conducted a multicenter study, which consisted of a double-blinded, randomized controlled study involving volunteer students earning degrees...

Does your paper address CONSORT subitem 3b? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study To be eligible for this trial, students needed to meet the following criteria: not having received any previous training in ultrasound imaging and... ; page 2-3 5/3/20 18:17 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study ...having the basic ability to use a mobile app, and having a mobile phone with Internet access running on the Android operating system. Page 2-3 5/3/20 18:17 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clariPed.
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. oqine), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email conPrmation, phone calls) were used to detect/prevent these. Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study ...volunteer students earning degrees in physical therapy from two public Spanish universities.

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta 5/3/20 18:17 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study "...Health Science Faculty at the University of Granada, Spain, or at the Campus of Tudela, University of Navarra, Spain..."

4b-i) Repo" if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study After students received theoretical and practical lessons about ultrasound skills in sports pathology areas, the role that the EcoPsio mobile app played was assessed in a traditional way and by means of the OSCE. The OSCE allows us to measure ultrasound competence as expressed in speciPc observable behaviors. ... 5/3/20 18:17 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta 5-i) Mention names, credential, a!liations of the developers, sponsors, and owners Mention names, credential, awliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conrict of interest" section or mentioned elsewhere in the manuscript). Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.

Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta 5/3/20 18:17 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta -v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing &owcha"s of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing rowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiPc reporting.

Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login. Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speciPc group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Both groups had 2 weeks to study after the on-site lessons. To prevent the control group from accessing information related to the mobile app, they were assessed before the EcoPsio group. The EcoPsio mobile app is focused on sports pathologies and contains relevant written and digital information about ultrasound imaging and management, as well as diagnosis of sport injuries. For each anatomical structure, there exists a theoretical description, a drawing with the anatomical description, an image with the speciPc placement of the ultrasound probe, an ultrasound slice, a diagram of the ultrasound image, and a video of the manual palpation procedure.... Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study After students received theoretical and practical lessons about ultrasound skills in sports pathology areas, the role that the EcoPsio mobile app played was assessed in a traditional way and by means of the OSCE. The OSCE allows us to measure ultrasound competence as expressed in speciPc observable behaviors...The theoretical and practical lessons were conducted by three professors and three teaching fellows; the teacher-to-student ratio was 1:6-8. The same lessons were taught in both universities by the same professors... There were a total of six contact sessions on site; this was followed by self-study time focused on the theoretical and practical learning of ultrasound imaging procedures, on different areas of the body, regarding sports pathologies. Each study group-EcoPsio intervention group and control group-attended 2 hours of theoretical lessons and 4 hours of practical lessons.....Both groups had 2 weeks to study after the on-site lessons. To prevent the control group from accessing information related to the mobile app, they were assessed before the EcoPsio group.....

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability). Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta 5-xi) Repo" any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Finally, there was a self-study period, where the EcoPsio group used the mobile app and the control group used traditional study models (eg, books and journal papers).... Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Not applicable.
Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes a#er the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 6a-iii) Describe whether, how, and when qualitative feedback from pa"icipants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text

Tu respuesta
Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Not applicable. subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 7a-i) Describe whether and how expected a'rition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.

Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study

Tu respuesta
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study It would require a power of 90% to detect a signiPcant mean difference of 3.5 (SD 3) points in the palpation assessment via the OSCE, assuming a type 1 error (alpha) of 5% and a type 2 error (beta) of 10%. Considering a dropout rate of 20%, we decided to enroll 55 subjects per group. Before the on-campus sessions, an independent researcher randomly assigned each participant to a group using Epidat 3.1 software (Xeral de Saúde Pública). And, statistical analysis.
5/3/20 18:17 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Página 34 de 57 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Before the on-campus sessions, an independent researcher randomly assigned each participant to a group using Epidat 3.1 software (Xeral de Saúde Pública).

Does your paper address CONSORT subitem 8b? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study We used a computer program to randomly assign a number to each student in both universities. These numbers were provided in numbered, opaque envelopes by an external study member to ensure that the study member responsible for outcome assessments was blinded to intervention and control group assignment. The envelopes were opened after a baseline assessment. 10) Who generated the random allocation sequence, who enrolled pa"icipants, and who assigned pa"icipants to interventions 11a) If done, who was blinded a#er assignment to interventions (for example, pa"icipants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study We used a computer program to randomly assign a number to each student in both universities. These numbers were provided in numbered, opaque envelopes by an external study member to ensure that the study member responsible for outcome assessments was blinded to intervention and control group assignment. The envelopes were opened after a baseline assessment.
Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study We used a computer program to randomly assign a number to each student in both universities. These numbers were provided in numbered, opaque envelopes by an external study member to ensure that the study member responsible for outcome assessments was blinded to intervention and control group assignment. The envelopes were opened after a baseline assessment. The assessment evaluator was blinded to both the assessment and the outcomes. 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study The assessment evaluator was blinded to both the assessment and the outcomes.The students were also blinded to the group to which they were assigned.
11a-ii) Discuss e.g., whether pa"icipants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Not applicable 5/3/20 18:17 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form

12a-i) Imputation techniques to deal with a'rition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Not applicable.

X26-i) Comment on ethics commi'ee approval
Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta 5/3/20 18:17 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline)

Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta 5/3/20 18:17 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Página 41 de 57 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full RESULTS 13a) For each group, the numbers of pa"icipants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions a#er randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study The Pnal sample was comprised of 50 students in the EcoPsio group and 55 students in the control group, with mean ages of 19.8 years (SD 2.1) and 19.7 years (SD 6.0), respectively. A tthe beginning of the study, there were no group differences in study variables such as gender or previous experience (see Table 1). There were 5 dropouts (5/55, 9%) in the EcoPsio group due to problems with the operating system versions of their mobile devices (see Figure 1).
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT &ow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study

13b-i) A'rition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other Pgures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the Pgure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study These students were in their Prst or second year of Physical Therapy Fundamentals and Physical Therapy Assessments courses or in their second year of the Physiology of Effort, Physical Exercise, and Health course during the 2014-2015 academic year. 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signiPcant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study

Tu respuesta
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study The study was registered at ClinicalTrials.gov (NCT04138511). 16) For each group, number of pa"icipants (denominator) included in each analysis and whether the analysis was by original assigned groups Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Table 1.

15-i) Repo" demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study 16-i) Repo" multiple "denominators" and provide de%nitions Report multiple "denominators" and provide dePnitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speciPc pre-dePned time points of interest (in absolute and relative numbers per group). Always clearly dePne "use" of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Results section.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).

Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta 5/3/20 18:17 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Página 46 de 57 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 17a) For each primary and secondary outcome, results for each group, and the estimated e&ect size and its precision (such as 95% con!dence interval) subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative e&ect sizes is recommended Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Results section, table 2, 3 and 4.

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational dePnitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is dePned (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study 18) Results of any other analyses pe'ormed, including subgroup analyses and adjusted analyses, distinguishing pre-speci!ed from exploratory subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Results section, table 2, 3 and 4.
Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Results section, table 2, 3 and 4.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

19) All impo"ant harms or unintended e&ects in each group
(for speciPc guidance see CONSORT for harms) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study There were 5 dropouts (5/55, 9%) in the EcoPsio group due to problems with the operating system versions of their mobile devices (see Figure 1).

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study 22-i) Restate study questions and summarize the answers suggested by the data, sta"ing with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study This work presents the results obtained on the use and ewcacy of an interactive platform accessible through mobile devices using ultrasound imaging for the development of professional competencies in the evaluation and diagnosis of sports injuries. The mobile app has demonstrated its effectiveness in the majority of the processes evaluated when compared with the traditional learning method. Moreover, the results revealed that the app is attractive and useful from the point of view of the students.

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events. Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Finally, we have to recognize some limitations of this research. Our study results with this mobile app should be supported in different countries and with different languages in order to extrapolate the results to other populations. On the other hand, we are aware of the fact that conducting the project during the course sessions may have prompted extra motivation among the students and that ultrasound imaging was an attractive tool for them to use; therefore, the results were quite good for both study groups. In this sense, it would be interesting to develop an independent study with the mobile app in other settings. Finally, there was no follow-up period with which to evaluate the sustainability of the benePts of this interactive platform. Nevertheless, this study also presents a number of strengths. This project was carried out in two different universities in Spain with an important sample of students; therefore, the results could be generalized to physiotherapy students. To our knowledge, this is one of the few studies that has been developed in the area of physiotherapy, showing the use of new technologies to complement traditional learning. In fact, we believe this is the Prst m-learning system designed to improve the acquisition of professional competencies in the assessment of sports pathologies. In addition, this mlearning system could be implemented in different areas of knowledge, such as sports medicine or sports sciences.

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations 5/3/20 18:17 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form

23) Registration number and name of trial registry
Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta 21-ii) Discuss if there were elements in the RCT that would be di$erent in a routine application se'ing Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study Tu respuesta 5/3/20 18:17 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Página 54 de 57 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other suppo" (such as supply of drugs), role of funders Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study ClinicalTrials.gov NCT04138511 Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study https://clinicaltrials.gov/ct2/show/NCT04138511 Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study This study was funded by a grant from the Educational Innovation Unit of the University of Granada, Spain (PID 14-56). This study was conducted thanks to the additional funding from the University of Granada, Plan Propio de Investigación 2016, Excellence actions: Units of Excellence; Unit of Excellence on Exercise and Health (UCEES).

X27) Con(icts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (Pnancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.

Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briery explain why the item is not applicable/relevant for your study

Tu respuesta
As a result of using this checklist, did you make changes in your manuscript? *