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Study of a Community Based Approach to Control Cardiovascular Risk Factors in India

NCT02115711 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1242

Last updated 2017-05-03

No results posted yet for this study

Summary

The study is a 2 year community based cluster randomized controlled trial to assess the role that a community health worker led intervention, in concert with physician education, can play in controlling the principal cardiovascular risk factors, i.e. hypertension, tobacco use, diabetes mellitus, physical inactivity and an unhealthy diet. Participants will include around 3600 adults, 35-70 years of age, from the urban community in the town of Dalkhola, Uttar Dinajpur district, West Bengal, India. The hypothesis of the study is that a community health worker based approach can result in increased control of Hypertension, Diabetes and Smoking.

Conditions

Interventions

BEHAVIORAL

Community health worker

The intervention is a multi-component one that is tailored to the individual and will target lifestyle changes, health seeking behavior and medication compliance. The CHW, after identifying the cardiovascular risk factors, will give advice about lifestyle interventions and will encourage hypertensives and diabetics to seek a physician. The first phase of the intervention will target hypertension, while the second phase which will be introduced 6 months after the first visit will target diabetes and smoking. The CHW will continue visiting the home of the participants every 2 months to reinforce the previous recommendations, seek to address reasons for non-adherence, address knowledge deficits and encourage physician visits.

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Sri Krishna M Mohan, MD · University Hospitals Cleveland Medical Center

  • Rishab Gupta, MD · AIIMS, New Delhi, India

  • Richard Josephson, MS, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02115711 on ClinicalTrials.gov