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

NCT07436104 | Completed Phase 4 DMC

• 1 other identifier: MAHAN MCPEPAG 2004/2
• Study Type: interventional
• Target: 72,564
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Adult mortality; Community-based; CRCT; Rural Tribal

Outcome Measures

Primary Outcomes (1)

• Age specific mortality rate (ASMR) 16 to 60 years age group.Age-specific mortality rate (ASMR) is calculated by dividing number of deaths in particular age group in a calendar year by mid-year population for that age group, multiplied by 100000.

  Comparison of change in ASMR (16-60 years) in IA vs CA from baseline to end of the study. The annual midyear population of persons aged 16-60 years was used as denominator for cal-culating ASMR of that year.Two-sample t-test across all yearly ASMR measurements (2005-2015 and 2017-2022) between arms was done to measure overall difference in mortality levels (treating each year's cluster-level ASMR as an independent observation). Simple linear regression of ASMR against year for each arm was performed for evaluation over time and comparison of the slope coefficients (trend in intervention vs control). The relative risk ratios (RRR)/ mortality rate ratio (MRR) was ob-tained for each study year to understand the effect of intervention as compared to control. Risk ratio (RR) were obtained in each arm as a ratio of number of deaths in one/two years to the mid-year population in 16-60 years group of respective years. Relative risk ratio (RRR) were obtained as a ratio of RR of IA v

  Baseline (Year 2004) to 2023 , annually for up to 19 years

Secondary Outcomes (2)

• Disease/cause specific mortality rate.Total no. of deaths (in the age group of 16-60 years) in one year due to one particular disease multiplied by 100000 and divided by total No. of people in the age group of 16 to 60 years in that year.

  Annual from 2004 to 2014.

• Efficacy of village health workers ( VHWs). Community based program delivered through VHW is effective for reducing adult mortality or not.

  Years: Baseline year to year of end of study . (Research phase: 11 years, replication phase: 7 years).

Study Arms (2)

Intervention arm: Treatment , BCC, Referral

EXPERIMENTAL

Trained village health workers (VHWs) in IA, provided behaviour change communication, treatment and referral. VHWs started treatment of HTN, diarrhoea, malaria, pneumonia, asthma and COPD by Amlodipine/Enalapril, ORS, tab-lets Norfloxacin, Chloroquine, Azithromycin, and Salbutamol Rotacaps/ tablet Der-riphylline respectively as per guidelines in villages. The VHW referred suspected TB patients to the hospital for early diagnosis and treatment un-der national TB program, and followed confirmed TB patients for completion of treatment. We started BCC about hypertension, tuberculosis, pneumonia, diarrhoea, malaria, asthma and COPD, in phase wise manner. The VHWs advised appropriate referrals to the some needy patients where they received standard hospital care. Contamination of the interventions were prevented as the IA and CA are different villages.

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; Other: Appropriate referral

Control arm: standard of care

ACTIVE COMPARATOR

This arm received appropriate referral and the standard care of treatment from hospital only. The VHWs did not provide treatment in villages.

Other: Appropriate referral

Interventions

Appropriate referral OTHER

The VHWs in control area provided appropriate referral.

Control arm: standard of care; Intervention arm: Treatment , BCC, Referral

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

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.

Also known as: Behaviour change Communication BCC: hypertension, tuberculosis, pneumonia, diarrhoea, malaria, asthma and COPD. Methods: lecture, counselling, audiovisuals, gramsabha, demonstrations, street play, Referral to hospital.

Intervention arm: Treatment , BCC, Referral

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All individuals aged 16-60 years residing in the study villages who gave written informed con-sent/assent were included as participants.
• De-facto (only in study village or hospital) and de-jure methods (outside study villages) were used during research phase.
• De-facto method for replication phase.

You may not qualify if:

• Out-migrants \>6 months, were excluded from analysis.

Sponsors & Collaborators

• MAHAN Trust: lead
• Caring Friends, Mumbai: collaborator
• Stitchting Geron, The Netherland: collaborator
• Mastek Foundation: collaborator
• Tribal Development Department, Government of India: collaborator

Study Sites (1)

Mahatma Gandhi Tribal Hospital Karmgram Utavali Dharni Amaravati

Amravati, Maharashtra, 444702, India

Location

Related Publications (4)

• Hunter DJ, Reddy KS. Noncommunicable diseases. N Engl J Med. 2013 Oct 3;369(14):1336-43. doi: 10.1056/NEJMra1109345. No abstract available.

  PMID: 24088093 BACKGROUND

• Masquelier B, Hug L, Sharrow D, You D, Mathers C, Gerland P, Alkema L; UN Inter-agency Group for Child Mortality Estimation. Global, regional, and national mortality trends in youth aged 15-24 years between 1990 and 2019: a systematic analysis. Lancet Glob Health. 2021 Apr;9(4):e409-e417. doi: 10.1016/S2214-109X(21)00023-1. Epub 2021 Mar 1.

  PMID: 33662320 BACKGROUND

• Sharma D, Kiran T, Goel K, Junaid KP, Rajagopal V, Gupta M, Kaundal H, Sharma S, Bahl A. Comprehensive assessment of age-specific mortality rate and its incremental changes using a composite measure: A sub-national analysis of rural Indian women. Front Med (Lausanne). 2022 Nov 29;9:1046072. doi: 10.3389/fmed.2022.1046072. eCollection 2022.

  PMID: 36523773 BACKGROUND

• GBD 2021 Demographics Collaborators. Global age-sex-specific mortality, life expectancy, and population estimates in 204 countries and territories and 811 subnational locations, 1950-2021, and the impact of the COVID-19 pandemic: a comprehensive demographic analysis for the Global Burden of Disease Study 2021. Lancet. 2024 May 18;403(10440):1989-2056. doi: 10.1016/S0140-6736(24)00476-8. Epub 2024 Mar 11.

  PMID: 38484753 BACKGROUND

Related Links

• Community-based Management of Adult Diseases for Reducing Mortality in Economically Productive age-group: Cluster Randomized Control Trial in India: 2004 -2022.

MeSH Terms

Conditions

Hypertension; Diarrhea; Pneumonia; Malaria; Pulmonary Disease, Chronic Obstructive; Asthma; Disease

Interventions

ORALIT; Norfloxacin; Chloroquine; Azithromycin; Counseling; Referral and Consultation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Protozoan Infections; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminoquinolines; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Ashish R Satav, MBBS, MD

  MAHAN Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Co-investigators, biostatistician, data team,
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Community based, cluster randomised controlled trial (CRCT) with parallel arm, open label, was conducted in 34 tribal villages/clusters of Melghat during research phase (2004-2015).

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 27, 2026
• Study Start: January 1, 2004
• Primary Completion: December 31, 2015
• Study Completion: August 31, 2023
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be shared beginning 6 months after publication of this article upto 2 years after publication
• Access Criteria: Data will be shared to researchers whose proposed use of the data has been approved by an independent review committee, for the pur-pose of academic analysis. For this sharing, a signed data access agreement is needed.

Locations

IN (1)