Effect of behavioural intervention using education and SMS reminders on medication adherence in chronic kidney disease patients with co-existing cardiovascular disease-A randomised controlled trial

Background:

The burden of chronic kidney disease is exponentially increasing. The complexity of treatment, lack of knowledge and increasing number of associated comorbidities lead on to non-adherence to treatment. Poor adherence to the treatment is a key factor that leads to progression of disease and mortality especially the cardiovascular mortality. The SMS  and education based intervention is found to improve medication adherence in many diseases.There are no SMS based behavioral intervention studies to improve adherence in Chronic kidney disease with coexisting cardiovascular disease in India. we confirmed this by searching PUBMED using the following MeSH terms from years 2007 to June 2017: behavioral intervention, SMS, chronic kidney disease, chronic kidney disease and cardiovascular disease and adherence.We are therefore proposing a behavioral interventional study using education and SMS reminders to assess its effect on medication adherence among patients with co-existing CKD and CVD

Objective:

Among Chronic kidney disease patients with established cardiovascular disease or its risk factors visiting a tertiary care teaching hospital:

Primary objective:

-       To assess the effect of education and SMS reminders on medication adherence at 3 months

Secondary objectives:

-       To assess the clinical outcomes at the end of 3 months

-       To assess the Knowledge, Attitude and Practices (KAP) about disease at the end of 3 months in both groups

Methodology:

 - In-patients will be identified as per selection criteria mentioned above from the relevant departments of St. Johns medical college hospital. The consultants from the respective deparments will help in indentification of cases. A written informed consent from the patient and his/her first degree relative will be taken. We random list the days of recruitment from the in-patient wards of relevant departments based on computer generated random list.Then we will note down the baseline demographic data, KAP, lab parameters and medication adherence using morisky adherence measuring scale and pill count method.   - Then we randomize the patient using a variable block randomization in a 1:1 allocation ratio to either intervention or control group   - Intervention group received education using a booklet at the time of discharge which has pill intake records at the end. They will also been given motivational discussion based on barriers identified at baseline and at every follow-up. The patients in intervention will also been sent one SMS in week based on 4 domains. During the 1st month follow-up either personal or through mobile, we ask about message delivery, give motivational discussion and also we measure adherence. During the final follow-up at 3rd month we measure KAP, clinical status and medication adherence

- Control group received usual standard care with routine follow-up with the physician and regular advice about the diet and medication by the physician. During the 1st month follow-up either personal or through mobile, we ask about message delivery and also we measure adherence. During the final follow-up at 3rd month we measure KAP, clinical status and medication adherence.

Statistical methods:

-Data entry will be done using Epi Info version 7.2. All statistical analyses will be performed using Statistics Package for the Social Sciences (SPSS) version 21.

-Demographic and base line variables such as age, gender, socio-economic status will be analysed using descriptive statistics.

-Continuous variables such as glucose levels, HbA1C, BP, lipid profile and serum creatinine levels will be summarized using mean (± SD) and analysed using t-test/ANOVA.

-Clinical / lab parameters between 2 groups will be analysed using Chi-square or student t-test.

-Difference of change in adherence between the two groups from baseline will be analysed using chi squared tests and determinants of adherence explored using multivariate analysis.

A p value <0.05 will be considered significant for all tests.