Comparing the Effects of Gamification and Teach-Back Training Methods on Adherence to a Therapeutic Regimen in Patients After Coronary Artery Bypass Graft Surgery: Randomized Clinical Trial

Background Patients undergoing coronary artery bypass graft surgery (CABGS) may fail to adhere to their treatment regimen for many reasons. Among these, one of the most important reasons for nonadherence is the inadequate training of such patients or training using inappropriate methods. Objective This study aimed to compare the effect of gamification and teach-back training methods on adherence to a therapeutic regimen in patients after CABGS. Methods This randomized clinical trial was conducted on 123 patients undergoing CABGS in Tehran, Iran, in 2019. Training was provided to the teach-back group individually. In the gamification group, an app developed for the purpose was installed on each patient’s smartphone, with training given via this device. The control group received usual care, or routine training. Adherence to the therapeutic regimen was assessed using a questionnaire on adherence to a therapeutic regimen (physical activity and dietary regimen) and an adherence scale as a pretest and a 1-month posttest. Results One-way analysis of variance (ANOVA) for comparing the mean scores of teach-back and gamification training methods showed that the mean normalized scores for the dietary regimen (P<.001, F=71.80), movement regimen (P<.001, F=124.53), and medication regimen (P<.001, F=9.66) before and after intervention were significantly different between the teach-back, gamification, and control groups. In addition, the results of the Dunnett test showed that the teach-back and gamification groups were significantly different from the control group in all three treatment regimen methods. There was no statistically significant difference in adherence to the therapeutic regimen between the teach-back and control groups. Conclusions Based on the results of this study, the use of teach-back and gamification training approaches may be suggested for patients after CABGS to facilitate adherence to the therapeutic regimen. Trial Registration Iranian Registry of Clinical Trials IRCT20111203008286N8; https://en.irct.ir/trial/41507


2a-i) Problem and the type of system/solution
Compare the effect of gamification and teach-back training methods on adherence to a therapeutic regimen in patients after CABGS 2a-ii) Scientific background, rationale: What is known about the (type of) system Due to the importance of patient education in the development of self-care and the increasing use of modern educational approaches, the aim of this study was to compare the effect of gamification and teach-back training methods on adherence to the therapeutic regimen in patients after CABGS. The primary outcome was a score on adherence to the therapeutic regimen.

Does your paper address CONSORT subitem 2b?
Due to the importance of patient education in the development of self-care and the increasing use of modern educational approaches, the aim of this study was to compare the effect of gamification and teach-back training methods on adherence to the therapeutic regimen in patients after CABGS. The primary outcome was a score on adherence to the therapeutic regimen METHODS

3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio
The patients who met the study inclusion criteria were randomly divided into three groups of 41 each using randomized block design and software. To decrease the predictability of allocated groups and ensure randomizing participants in an equal number, we used block randomization with size 4. Allocation in each group was random but equal in size. 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons Inclusion criteria were an age range of 18-60 years, an Android phone for the patient, nonuse of psychotropic drugs, the ability to understand and speak Persian, willingness to participate in the study, lack of hearing and speech disorders, and the ability to receive phone calls after discharge. Exclusion criteria were the patient's unwillingness to continue an education process and acute illness requiring emergency intervention 3b-i) Bug fixes, Downtimes, Content Changes 4a) CONSORT: Eligibility criteria for participants an Android phone for the patient,the ability to receive phone calls after discharge 4a-i) Computer / Internet literacy 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: They acess offline. For patients in the gamification group, informed consent was obtained and a pretest questionnaire completed. The training program was installed on each patient's smartphone during discharge, and the researcher explained to the participants how to use the game. 4a-iii) Information giving during recruitment 4b) CONSORT: Settings and locations where the data were collected Authors don't mention any conflict of interst 4b-i) Report if outcomes were (self-)assessed through online questionnaires Prior to training, each patient completed an informed consent form, a demographic questionnaire, a questionnaire on adherence to a therapeutic regimen (physical activity and dietary regimen) designed by Sanaie et al , and Adherence Scale 4b-ii) Report how institutional affiliations are displayed 5) CONSORT: Describe the interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners 5-ii) Describe the history/development process 5-iii) Revisions and updating 5-iv) Quality assurance methods 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used

5-vii) Access
The reliability of the questionnaires was measured by the Cronbach alpha value (α=.81).
To confirm content validity, the questionnaires was presented to 10 faculty members of the School of Nursing and Midwifery, Tehran University of Medical Sciences, in addition to a nutritionist, a physiotherapist, a sports medicine specialist, a cardiologist, and an interventional cardiologist. After collecting their comments, corrective and suggested comments were applied.

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
The questionnaire was completed by the patients n three groups before discharge and then 30 days later during a home visit 5-ix) Describe use parameters 5-x) Clarify the level of human involvement 5-xi) Report any prompts/reminders used The researchers sent reminder text messages to participants in the teachback and gamification group each week

5-xii) Describe any co-interventions (incl. training/support)
We didn't have any additional education 6a) CONSORT: Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed The demographic questionnaire included information about age, sex, education, and source of information about the study. In addition, the patient's health record was referred to obtain details on medical history, past surgery, and type of medication. The questionnaire on adherence to a therapeutic regimen designed by Sanaie et al.The second part includes 19 questions about the patient's movement regimen (eg, walking, breathing exercises, and spirometer). The options are scored from never to always (0 to 110) using a 5-point Likert scale. The total adherence rate of the physical activity regimen, where 100% represents a total score of 1900, is considered as follows: <50% of the total score (<950), undesired adherence; 50%-75% of the total score (950-1425), relatively desired adherence; and >75% of the total score (>1425), desired adherence. 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained 6b) CONSORT: Any changes to trial outcomes after the trial commenced, with reasons Authors don't mention any conflict of interst 7a) CONSORT: How sample size was determined 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size 7b) CONSORT: When applicable, explanation of any interim analyses and stopping guidelines The demographic questionnaire included information about age, sex, education, and source of information about the study. In addition, the patient's health record was referred to obtain details on medical history, past surgery, and type of medication. The questionnaire on adherence to a therapeutic regimen designed by Sanaie et al.The second part includes 19 questions about the patient's movement regimen (eg, walking, breathing exercises, and spirometer). The options are scored from never to always (0 to 110) using a 5-point Likert scale. The total adherence rate of the physical activity regimen, where 100% represents a total score of 1900, is considered as follows: <50% of the total score (<950), undesired adherence; 50%-75% of the total score (950-1425), relatively desired adherence; and >75% of the total score (>1425), desired adherence. 8a) CONSORT: Method used to generate the random allocation sequence The patients who met the study inclusion criteria were randomly divided into three groups of 41 each using randomized block design and software. To decrease the predictability of allocated groups and ensure randomizing participants in an equal number, we used block randomization with size 4. Allocation in each group was random but equal in size.

8b) CONSORT: Type of randomisation; details of any restriction (such as blocking and block size)
The patients who met the study inclusion criteria were randomly divided into three groups of 41 each using randomized block design and software. To decrease the predictability of allocated groups and ensure randomizing participants in an equal number, we used block randomization with size 4. Allocation in each group was random but equal in size. 9) CONSORT: 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 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 10) CONSORT: Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 11a) CONSORT: Blinding -If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11a-i) Specify who was blinded, and who wasn't We didn't have blind participants 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator"

11b) CONSORT: If relevant, description of the similarity of interventions
We didn't have this item in this study 12a) CONSORT: Statistical methods used to compare groups for primary and secondary outcomes Data were analyzed with SPSS Statistics version 20 (IBM) and STATA version 12 (StataCorp) using the Fisher exact test, chi-square test, independent ttest, analysis of variance (ANOVA), and Dunnett test. 12a-i) Imputation techniques to deal with attrition / missing values Data were analyzed with SPSS Statistics version 20 (IBM) and STATA version 12 (StataCorp) using the Fisher exact test, chi-square test, independent ttest, analysis of variance (ANOVA), and Dunnett test. we didn't have missing values 12b) CONSORT: Methods for additional analyses, such as subgroup analyses and adjusted analyses We didn't have subgroup nalysis RESULTS 13a) CONSORT: For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome a sample size of 123 people (41 people in each group( 13b) CONSORT: For each group, losses and exclusions after randomisation, together with reasons We mentioned the number and cause of sample loss in each group separately 13b-i) Attrition diagram 14a) CONSORT: Dates defining the periods of recruitment and follow-up . In addition, training was provided individually and outside of the inpatient ward, in a separate room, to prevent data transfer to other patients. In addition, a training booklet was given to patients in the teach-back group in order to access information within a 30-day period. Finally, 30 days later, the questionnaire was recompleted by visiting the patient at home, in person. It should be noted that the educational content of both groups was identical. 14a-i) Indicate if critical "secular events" fell into the study period 14b) CONSORT: Why the trial ended or was stopped (early) We reached the desired sample size and sampling stopped

15) CONSORT: A table showing baseline demographic and clinical characteristics for each group
The results of this study showed that 64.68% of the samples in the gamification group, 51.35% in the teach-back group, and 62.66% in the control group were male. Other demographic characteristics of the patients are listed in Table 1.

15-i) Report demographics associated with digital divide issues
Age, Gender, Educational Statuse, Income status,Chronic condition,Source of information ,...reported 16a) CONSORT: For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 16-i) Report multiple "denominators" and provide definitions We reported P-value, Confidence interval and Mean(sd) 16-ii) Primary analysis should be intent-to-treat 17a) CONSORT: For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) We reported for each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 17a-i) Presentation of process outcomes such as metrics of use and intensity of use 17b) CONSORT: For binary outcomes, presentation of both absolute and relative effect sizes is recommended Not applicable in the present study 18) CONSORT: Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory We didn't have subgroup analysis 18-i) Subgroup analysis of comparing only users

19) CONSORT: All important harms or unintended effects in each group
We had no harms in this study 19-i) Include privacy breaches, technical problems

20) CONSORT: Trial limitations, addressing sources of potential bias, imprecision, multiplicity of analyses 20-i) Typical limitations in ehealth trials
We had to rely on the patients' self-report on exercising at home and following the dietary and medication regimens. In addition, the patients did not record the number of games and browse the application. The app did not include the feature to send reminders and the ability for patients to interact with it. We suggest further studies with a larger sample size and an interactive app with the ability to record usage and to send reminders. In addition, it is recommended that studies be performed in the presence of active family member inpatient care using these approaches.