Community-based Screening of Chronic Kidney Disease (CKD) and Measure the Impact of Health Education

This would be a community-based randomized controlled trial (RCT) among the individuals diagnosed as having CKD with stage 1-3 who agreed to participate.

Registration/Enrolment of participants:

Community health workers (CHWs) will perform home -visits to obtain written informed consent, perform physical examination, and interview the respondents administering field tested questionnaires.

Interviewing by administering a structured questionnaire: if changed from Study 1: Age, gender, marital status, occupation, educational background, income/month, participant's current medical history including medication use, past medical history, sleeping hours, and family history (3rd generation) including current and immediate past medical history.

Physical examinations will be performed to measure: Blood pressure, pulse, height, weight, waist circumference, hip circumference, triceps skin fold (TSF), mid-upper arm circumference (MUAC), body mass index (BMI) and mid-arm muscle circumference (MAMC).

Blood sample (at hospital) Serum creatinine (estimate eGFR), serum albumin, Hb%, FBS, HbA1C, lipid profile (TP, HDL-c, LDL-c, triglyceride, and ratio: estimate non-HDL), serum uric acid, Urea (BUN).

Urine specimens (at hospital) Albumin to creatinine ratio (ACR), urine RME, urine Na (calculate sodium intake)

Questionnaires/Interviewing :

Chronic Kidney Disease Knowledge Questionnaire (24 questions) Awareness question (1 question) QOL (5 EURO-QOL questionnaire) Randomisation: A simple randomization (1:1) either intervention group or control group will be undertaken following a computer-generated random number sequence. An experienced statistician, who will not be involved in the study in any way, will prepare the randomization table and list of study participants' numbers with corresponding intervention allocations for CKD individual in serially numbered sealed envelopes according to randomization schedule to correspond to the serial number of the CKD individuals. These envelopes will be kept in an office locker. Allocation will be concealed in identical sealed envelopes that will only be opened when the study participant is ready for enrolment. This will take place after a CKD individual has been enrolled in the study following obtaining voluntarily informed written consent and assigning a study number. Necessary attempts will be made to keep CHWs unaware about case/control status of the participants. Similar approach will also be followed at the time of data analysis.

Study contents:

The intervention group will receive health education through CKD campaign and mHealth technology. During the half day CKD campaign, health education materials (leaflet and short textbook and recording notebook) will be provided to the study participants. A nephrologist will facilitate the campaign and contents (Annex-3) of the text book and leaflet (Annex-4) will be discussed. Important message from the text book (such as stage, risk factor, preventive measures) will be used to develop the leaflet. In addition, education through mHealth will be provided by Short Message Service (SMS) during the study period. The contents of the SMS are: 1). Reduce salt intake; 2) Do exercise and take medicine regularly; 3). Control blood pressure (if hypertensive) and blood sugar (if diabetic); and 4) Avoid painkiller and smoking will be sent to the participants using mobile phone once a week for first 2.5 months and once a 2-week for next 3 months.

The CKD knowledge questionnaire consisted a total of 24 questions with the multiple-choice options 'true', 'false' and 'I don't know'. The validated questionnaire will be adapted according to Bangldesh context and will be pre-tested before starting the study. The quality of life will be assessed using an adapted and validated Bangla version of the 5 EURO-QOL questionnaire. It has five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

Sample size calculation:

Assuming that proportion of knowledge and awareness among CKD patients at baseline as 30%; and at the end of six months it will increase to 70% (intervention group) and 40% (control group). Therefore, considering 90% power and 20% loss to follow-up the total sample size will be 136 (68 in each group).

Data analysis:

The descriptive statistics will be expressed as frequency, mean, median, cross tabulation, and standard deviation. Chi-square test, t-test or Mann-Whitney U-test will be performed to see the differences between intervention group and control group at baseline, 3 and 6 months. Multiple comparisons will be performed by ANOVA test for evaluation of the outcome variables such as CKD knowledge and awareness questionnaire and QOL at baseline, 3 and 6 months. Data will be analyzed using SPSS ver. 22.0 (IBM Co., Armonk, NY) and the significance level will be set at the level of p < 5%.