Effectiveness of peer-led intervention in control of non-communicable diseases in rural areas of Khordha district: study protocol for a cluster randomized controlled trial.

ABSTRACT

BACKGROUND: The main contributors to death and disability from chronic illnesses in developing nations are elevated blood pressure (hypertension), blood sugar (diabetes mellitus), and blood cholesterol (dyslipidaemia). Even though there are affordable treatments, the treatment gap for these conditions is still significant. Few pilot studies from industrialized nations discuss the value of peer-led interventions for achieving community-level management of blood pressure and blood sugar. This study aims to evaluate the effectiveness of peer-led intervention compared to standard care in achieving control of selected non-communicable diseases (NCDs) in Indian context at 1 year of intervention among people of 30-60 years with hypertension and/or diabetes mellitus and/or dyslipidaemia. METHODS: A cluster-randomized controlled trial will be conducted in villages of two rural blocks of the Khordha district of Odisha from August 2023 to December 2024. A total of 720 eligible participants (360 in the intervention group and 360 in the control group) will be recruited and randomized into two study arms. The participants in the intervention arm will receive a peer-led intervention model for 6 months in addition to standard care. The sessions will be based on the six domains of NCDs - self-care, follow-up care, medication, physical activity, diet, limiting substance use, mental health and co-morbidities. The mean reduction in blood pressure, HbA1C, and blood cholesterol in the intervention arm compared to the standard care arm will be the main outcome. DISCUSSION: The increasing burden of NCDs demands for newer strategies for management. Peer-led interventions have proven to be useful at the international level. Incorporating it in India will have remarkable results in controlling NCDs. TRIAL REGISTRATION Clinical Trial Registry of India (CTRI) CTRI/2023/02/050022. Registered on 23 February 2023.