Chronic Kidney Disease Awareness Campaign and Mobile Health Education to Improve Knowledge, Quality of Life, and Motivation for a Healthy Lifestyle Among Patients With Chronic Kidney Disease in Bangladesh: Randomized Controlled Trial

Background Chronic kidney disease (CKD) is linked to major health consequences and a poor quality of life. Despite the fact that CKD is becoming more prevalent, public knowledge of the disease remains low. Objective This study aimed to evaluate the outcome of a health education intervention designed to enhance knowledge, health-related quality of life (QOL), and motivation about healthy lifestyle among adults with CKD. Methods This study was a parallel-group (1:1), randomized controlled trial in the Mirzapur subdistrict of Bangladesh that compared 2 groups of patients with CKD. Adults with CKD (stages 1-3) were enrolled in November 2020 and randomly assigned the intervention or control group. The intervention group received health education through a CKD awareness campaign and mobile health technologies and was observed for 6 months, whereas the control group received standard treatment. The primary outcome was the evaluation of improved scores on the CKD knowledge questionnaire, and the secondary outcomes were improved QOL and changes in the levels of blood pressure (BP), BMI, serum creatinine, fasting blood sugar (FBS), hemoglobin, cholesterol, high-density lipoprotein cholesterol, triglyceride, serum uric acid, blood urea nitrogen (BUN), and albumin-to-creatinine ratio. Results The study enrolled 126 patients (control: n=63; intervention: n=63) and performed intention-to-treat analysis. The analyses included repeated measures ANOVA, and the results were observed to be significantly different from within groups (P<.001), between groups (P<.001), and the interaction of group × time factor (P<.001) for knowledge score. Diastolic BP and BMI showed significant differences arising from within groups (P<.001 and P=.01, respectively) and the interaction of group × time factor (P=.001 and P=.02, respectively); food salinity and hip circumferences showed significant differences arising from within groups (P=.001 and P=.03, respectively) and between groups (P=.001 and P=.02, respectively). Moreover, systolic BP and waist circumference showed significant differences from within groups (P<.001 and P=.003, respectively). However, no significant differences were found arising from within groups, between groups, and the interactions of group × time for QOL, urine salinity, and mid-upper arm circumference. Regarding the laboratory findings, from baseline to 6 months, the mean (SD) FBS decreased by 0.51 (3.77) mmol/L in the intervention group and 0.10 (1.44) mmol/L in the control group (P=.03); however, blood urea nitrogen increased by 3.64 (7.17) mg/dL in the intervention group and 1.68 (10.10) mg/dL in the control group (P=.01). Conclusions The health education strategy, which included a campaign and mobile health, showed promise for enhancing CKD knowledge among patients with CKD. This strategy may also aid patients with CKD in controlling their FBS and BP. The combined health education initiatives give evidence for scaling them up in Bangladesh and possibly other low- and middle-income countries, particularly in rural and peri-urban settings. Trial Registration ClinicalTrials.gov NCT04094831; https://clinicaltrials.gov/ct2/show/NCT04094831. International Registered Report Identifier (IRRID) RR2-10.2196/30191


2a-i) Problem and the type of system/solution
Yes, we did not face any problem 2a-ii) Scientific background, rationale: What is known about the (type of) system Yes. CKD education in the early stages could be an integral part of patient management and reduction of the related risk factors, slowing down the progression of the disease, and the need for such education is greater in rural and peri-urban areas Does your paper address CONSORT subitem 2b?
Yes. the present study aims to evaluate the outcome of a health education intervention designed to enhance knowledge, health-related QOL, and motivation about healthy lifestyle among rural and peri-urban adults suffering from CKD (stage 1-3).

3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio
This study was a community-based, single-centered, prospective, open-label, two-arm (1:1), randomized control trial. 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons No, we did not made any changes after trial commencement. 3b-i) Bug fixes, Downtimes, Content Changes 4a) CONSORT: Eligibility criteria for participants Yes, inclusion and exclusion criteria was used to select the participants. 4a-i) Computer / Internet literacy 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Yes (mobile based) health education was provided. 4a-iii) Information giving during recruitment 4b) CONSORT: Settings and locations where the data were collected Mirjzapur subdistrict, Tangail, Bangladesh 4b-i) Report if outcomes were (self-)assessed through online questionnaires Health education was provided through mHealth 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
Not applicable as the participants did not need access to platform or internet.

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
Health education for CKD patients 5-ix) Describe use parameters

5-xi) Report any prompts/reminders used
Yes, we have called all the participants.

5-xii) Describe any co-interventions (incl. training/support)
Yes, training was provided to the community health workers 6a) CONSORT: Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Yes, primary and secondary outcomes were well defined. 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 6b) CONSORT: Any changes to trial outcomes after the trial commenced, with reasons Mirjzapur subdistrict, Tangail, Bangladesh 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 Yes, primary and secondary outcomes were well defined. 8a) CONSORT: Method used to generate the random allocation sequence Permuted block randomization technique was performed using a block size of six based on a computer-generated random number sequence. 8b) CONSORT: Type of randomisation; details of any restriction (such as blocking and block size) Permuted block randomization technique was performed using a block size of six based on a computer-generated random number sequence. 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 Allocation was concealed in identical sealed envelopes that were only opened when the study patient was ready for enrolment under the supervision of the principal investigator 10) CONSORT: Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions An experienced statistician, not involved in the study in any way, prepared the randomization table and listed study patients' numbers with corresponding intervention allocations for CKD patients in sequentially numbered sealed envelopes according to the randomization schedule to correspond to the serial number of the CKD patients 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 This study was a parallel-group (1:1) randomized controlled trial in the Mirzapur sub-district of Bangladesh that compared two groups of CKD patients. Adults individual with CKD (stages 1-3) were enrolled in November 2020 and randomly assigned to one of two groups: intervention or control 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 It was not a placebo control trial. 12a) CONSORT: Statistical methods used to compare groups for primary and secondary outcomes For the baseline assessment, continuous variables were compared by t-test or Man-Whitney U test, and categorical variables were compared by the chisquare (X2) test. Multiple comparisons were performed by two-way repeated measure ANOVA test for the evaluation of the outcome variables such as CKD knowledge questionnaire and physical measurements and QOL at baseline, three months, and six months.

12a-i) Imputation techniques to deal with attrition / missing values
Intention treat analysis were performed.

12b) CONSORT: Methods for additional analyses, such as subgroup analyses and adjusted analyses
Not applicable as we did not perform any sub group analysis. RESULTS 13a) CONSORT: For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome Yes, intention to treat analysis was performed 13b) CONSORT: For each group, losses and exclusions after randomisation, together with reasons A total enrolled of 126 patients (control group, n=63, intervention group, n=63) were enrolled in the study. Of them, five patients were withdrawn from further participation during the follow-up period. Among them, four were from the intervention group and one from the control group. Two patients in the intervention group did not participate in the health campaign, and the other two did not continue their health education. The only patient in the control group, on the other hand, left the area after enrolment into the study".

13b-i) Attrition diagram 14a) CONSORT: Dates defining the periods of recruitment and follow-up
The total study duration was one year; during that one year, the intervention duration was six months, starting from mid-November 2020 and completed in May 2021 14a-i) Indicate if critical "secular events" fell into the study period 14b) CONSORT: Why the trial ended or was stopped (early) Not applicable as it was not stopped (early).

15) CONSORT: A table showing baseline demographic and clinical characteristics for each group
Yes, baseline characteristics was provided.

15-i) Report demographics associated with digital divide issues
Yes. Age, gender, education was provided in demographics characteristics was provided. 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 Yes, clearly defined the denominators. 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) Yes. Estimated effect size and its precision. 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 For binary outcomes, presentation of both absolute and relative effect sizes was measured 18) CONSORT: Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Repeated measure ANOVA and Generalized Estimating Equation (GEE) was performed

19) CONSORT: All important harms or unintended effects in each group
No any important harm was observed.