Improving Health Literacy on Chronic Kidney Disease Among Diabetics: the Malaysian Nutritional, Emotional and Physical Health Literacy for Optimal Renal Outcome (My-NEPHRO) Trial

This will be a randomized controlled interventional trial. MyNEPHRO module will be developed and validated, and integrated within a mobile application. The mobile app intervention is to be delivered for 6 months with multiple approaches for the intervention. Eligible adults aged more than 18 years old with diabetes and non-dialysis chronic kidney disease will be assigned to one of two study groups (intervention or usual care control groups) in a 1:1 ratio using simple randomization. The trial will be carried out in the district of Kuala Terengganu, in the state of Terengganu, Malaysia.

Sample size was calculated for all objectives with available published parameters, using PS software. The largest sample size is 102, which is 51 for intervention and 51 for control group; including a 20% increase to consider loss to follow up. The following equation was used (Florey, 1993):

n (sample size in each group) = 2 [(a + b)2 x σ2] / (μ1 - μ2)2 where: a = conventional multiplier for alpha (0.05) = 1.96 and b = conventional multiplier for power (0.80) = 0.842. Considering the difference in the change in % HbA1c by 0.5% between groups and standard deviation (SD) of the change in % HbA1c by 0.8 (Seangpraw et al., 2023), a sample size of 41 adults per group will give 80% power at 0.05 significance level.

Recruitment The target sample comprises of 102 adults with diabetes who live in Kuala Terengganu, Terengganu, Malaysia, with non-dialysis CKD. The study flow is as outlined in Figure 3. Health campaign regarding diabetes will be done targeting patients attending the medical clinic in a university hospital. Potential subjects will be recruited during the programmes by identifying them using a google form for inclusion and exclusion criteria. Those fulfilling the inclusion and exclusion criteria will be contacted via phone and explained regarding the study. The start of the study by each participant will be defined by the dates of the baseline HbA1C level for each participant. The baseline HbA1C level is taken from the blood investigation done during their regular follow-up, which should be within one month of recruitment into the intervention or control group.

Randomisation will be performed by the co-investigator (SWW) in this trial, once the baseline data collection is completed. Each participant will be to either the intervention or control group by a 1:1 ratio simple randomisation. The Research Randomiser software, will generate random numbers using the "Math.random" method with JavaScript programming for the intervention group. The group assigned will be inserted in envelopes according to the number generated. The co-investigator will select the envelope sequentially and contact each participant to inform the group (intervention or control) he/she will be allocated to and instruct on the next processes according to the group assigned. This study uses the single-blind approach. Assessments will be done at baseline, 3-months and 6-months by the main researcher (NMH), who will remain blinded to group allocations throughout the study.

Assessment of health literacy Self-administered HLS-M-Q18 questionnaire. This questionnaire was adapted and compressed from the Health Literacy Survey European Questionnaire 47 (HLS-EU-Q47). and was pretested and validated in Malaysia. Instrument reliability showed all major domains in HLS-M-Q18 had a Cronbach's Alpha value greater than 0.7 (Mohamad et al, 2020).

Assessment of Quality of Life The WHO has developed an instrument called the WHOQOL to measure various subjective aspects of quality of life. Among these instruments, the WHOQOL-BREF is widely recognized for its applicability in cross-cultural comparisons of quality of life, and it is available in over 40 languages. The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items (Vahedi, 2010).

Baseline sociodemographic assessment Sociodemographic variables encompass age, sex, race, education level (primary, secondary, or tertiary), and household income.

Statistical Analysis Statistical analyses will be conducted using the Statistical Package for the Social Sciences (SPSS Version 25). Descriptive statistics is used to characterize the overall respondents. For numerical outcomes: Independent t test (between group comparison), Paired t-test (within group comparison), and Repeated measure ANCOVA will be used for parametric testing for comparing the intervention and control group and/or by time, respectively. A p-value of 0.05 and less is considered significant.

The time points of repeated measures of data collection, which were collected at baseline, 6-month intervals, serve as within-subject independent variables. On the other hand, the number of groups in the study which consisted of the intervention group and the usual care control group, serve as between-subject independent variables. The dependent variables of the study were mean changes in creatinine, eGFR, HbA1c level, blood pressure and health-related quality of life level.

Ethical consideration It will be emphasized that participation in the study will be voluntary, that responses would be treated confidentially, that results would be reported anonymously, and that it was possible to withdraw from the study at any time without penalty or jeopardizing their care. A small gift will be given to the participants as appreciation. The pretest and post-test questionnaires will be linked with the use of participants' e-mail addresses. All the participants will provide their informed consent.