Effectiveness of Targeted Client Communication for self-care of Diabetes Mellitus and Hypertension in Puducherry - An embedded mixed methods pilot study

Title: Effectiveness of Targeted Client Communication for self-care of Diabetes Mellitus and Hypertension in Puducherry - An embedded mixed methods pilot study

Primary objective:

Among people living with Diabetes Mellitus, Hypertension or both availing treatment from public health facilities in Puducherry,

1. To develop a Targeted Client Communication using smartphone (WhatsApp messaging) for improving self-care practices

2. To determine the clinical and behavioural outcomes at the end of 6 months intervention in comparison to the standard of care

Secondary objective:

To explore the facilitators and barriers and user engagement of the Targeted Client Communication for self-care in people living with Diabetes Mellitus, Hypertension or both availing treatment from public health facilities in Puducherry, from the patients’ and Health Care Providers’ perspective

Study design: Non-Randomized Controlled Trial

Site of study: PHC Mettupalayam

Sampling: Purposive sampling for qualitative phase; Consecutive sampling for qualitative phase.

Sample size: Intervention arm - 100, Standard of care arm - 100; For qualitative phase - Participants will be interviewed until data saturation.

Statistical analysis: All continuous variables will be summarized as Mean with Standard Deviation or Median with Inter-Quartile Range based on normality of data.

All categorical variables will be summarized as frequency with proportion. The baseline characteristics of the study participants in the two groups will be compared. A Difference-In-difference analysis will be performed to estimate the mean change in the outcome variable between the two groups over the time period. McNemar Chi-Squared test will be used to determine the change in the proportion of the outcome variable from baseline to endline between the two groups. A p-value of 0.05 will be considered for statistical significance.

Qualitative analysis: The interviews will be converted into transcripts within the same day using the audio recording. Manual descriptive content analysis will be done. Transcripts will be reviewed by another person to decrease bias and increase the interpretive credibility. Any difference between the two will be resolved by discussion. Decision on coding rules and theme generation will be done using standard procedure and consensus. The findings will be reported using COnsolidated criteria for Reporting Qualitative research (COREQ). Integration will be attempted at the design stage (sampling technique) and analysis stage (joint displays) and a framework for patient engagement in digital health interventions will be developed.