Effect of peer-group therapy on medication adherence among patients of diabetes and/or hypertension in rural settings across India

Effectiveness of peer-group therapy using community based participatory research (CBPR) model on medication adherence among patients of diabetes and/or hypertension: Study protocol for a multi-centric cluster randomized trial in rural settings across India - NIL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061939

Enrollment

2880

Registered

2024-01-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Peer-group therapy: Peer-group therapy using community based participatory research (CBPR) model on medication adherence among patients of diabetes and/or hypertension Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: 1 Diagnosed case of diabetes and/or hypertension and are on medication(s). 2 Male or female aged 18 years or more. 3 Resident of village during the baseline survey. 4 Has no plans to migrate in next 12 months from the date of initiation of intervention.

Exclusion criteria

Exclusion criteria: 1 Persons who cannot provide informed consent or decline participation in the study 2 Persons with a terminal medical condition

Design outcomes

Primary

Measure	Time frame
The primary outcome is the improvement in medication adherence in diabetes and/or hypertension as measured using Morisky Medication Adherence Scale (MMAS 8).Timepoint: The outcome will be measured at 4th, 7th & 12th month and will be compared with the baseline	—

Secondary

Measure	Time frame
Secondary outcomes include improvement in health literacy measured using AAHLS (All Aspects of Health Literacy Scale), clinical outcomes related to diabetes & hypertension measured using Hb1AC & blood pressure measurement, quality of life measured using EURO-QoL (EQ-5D) & service user satisfaction measured using PSQ-18 (Patient Satisfaction Questionnaire Short Form). Along with this, process evaluation & return on investment (ROI) will be done. Timepoint: The outcomes of Health literacy, Clinical outcomes, Quality of life, Service User Satisfaction will be measured at 4th, 7th & 12th month & will be compared with the baseline. Process evaluation & return on investment (ROI) will be measured throughout the study.	—

Measure

Time frame

Secondary outcomes include improvement in health literacy measured using AAHLS (All Aspects of Health Literacy Scale), clinical outcomes related to diabetes & hypertension measured using Hb1AC & blood pressure measurement, quality of life measured using EURO-QoL (EQ-5D) & service user satisfaction measured using PSQ-18 (Patient Satisfaction Questionnaire Short Form). Along with this, process evaluation & return on investment (ROI) will be done. Timepoint: The outcomes of Health literacy, Clinical outcomes, Quality of life, Service User Satisfaction will be measured at 4th, 7th & 12th month & will be compared with the baseline. Process evaluation & return on investment (ROI) will be measured throughout the study.

—

Countries

India

Contacts

Public ContactDr Denny John

Centre for Public Health Research (CPHR), Kolkata

denny@cphr-mant.org9987021553

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026