Mortality Control Program for Economically Productive Age Group in Tribal Area of Melghat.

Summary

Background: Age specific mortality rate (ASMR) of 16-60 years is very high in Indian tribal areas due to communicable and non-communicable diseases.

Objectives:

The primary objective is to reduce the ASMR in 16-60 years age group by at-least 30% from 16 tribal villages of Melghat. The secondary objectives are to reduce cause-specific mortality rates (CSMR) in 16-60 years age group because of diarrhoea, malaria, pneumonia, etc.

Design: Community-based, single-centered, parallel-arm, cluster randomised controlled trial.

Setting: 36 tribal villages/clusters (research phase: 2004-2015) and 44 new villages (replication phase: 2016-2022) were externally randomized by lottery method to intervention arm (IA) or control arm (CA).

Participants: All persons in age group of 16-60 years from inaccessible 80 tribal villages.

Interventions: Trained VHWs in IA, provided behaviour change communication, treatment and referral. Except principal investigator, other study staff and participants were double blinded.

Conditions

• Hypertension (HTN)
• Diarrhea
• Pneumonia
• Malaria Fever
• COPD
• Asthma (Diagnosis)
• Diarrhea Chronic

Interventions

COMBINATION_PRODUCT

Trained village health workers (VHWs) , provided treatment of HTN, diarrhoea, malaria, pneumonia, asthma and COPD by Amlodipine, ORS, Norfloxacin, Chloroquine, Azithromycin, salbutamol rotacaps

Unlike traditional vertical programs that focus on a single disease, this study utilizes Village Health Workers (VHWs) to manage a broad diseases spectrum in villages, ranging from chronic NCDs like Hypertension (Amlodipine) and COPD/Asthma (Salbutamol Rotacaps/Derriphylline) to acute infectious diseases like diarrhoea, malaria, pneumonia, requiring Norfloxacin, Chloroquine, and Azithromycin. Key Differentiators * Holistic Mortality Targeting: While most Cluster Randomized Controlled Trials (CRCTs) focus on maternal or child health, this study specifically targets the Adult Specific Mortality Rate (ASMR). * Operational Sustainability: We combined Behavior Change Communication (BCC) with an integrated treatment and referral algorithm, a factor rarely captured in other intervention studies. * Temporal Stability: The 18-year duration ensures the findings are not skewed by transient epidemics/ seasonal outbreaks, establishing a benchmark for scalable, long-term health system strengthening.

OTHER

Appropriate referral

The VHWs in control area provided appropriate referral.

Sponsors & Collaborators

• Caring Friends, Mumbai

  collaborator UNKNOWN

• Stitchting Geron, The Netherland

  collaborator UNKNOWN

• Mastek Foundation

  collaborator UNKNOWN

• Tribal Development Department, Government of India

  collaborator UNKNOWN

• MAHAN Trust

  lead OTHER

Principal Investigators

• Ashish R Satav, MBBS, MD · MAHAN Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2004-01-01

Primary Completion

2015-12-31

Completion

2023-08-31

Countries

• India

Study Locations