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

NCT02115711 | Completed

• 1 other identifier: 02-14-22
• Study Type: interventional
• Target: 1,242
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension; Diabetes; Smoking; Cardiovascular Diseases

Keywords

India; Cardiovascular risk factors; Community health workers; Hypertension; Diabetes; Smoking

Outcome Measures

Primary Outcomes (3)

• Absolute reduction of systolic blood pressure in Hypertensives

  Absolute reduction in SBP amongst hypertensives, .

  2 years

• Absolute reduction in fasting blood glucose amongst Diabetics

  Absolute reduction in fasting blood glucose amongst diabetics

  2 years

• Absolute reduction in average number of cigarettes/bidis smoked per day amongst smokers

  Absolute reduction in average number of cigarettes/bidis smoked per day amongst smokers

  2 years

Secondary Outcomes (10)

• Absolute mean reduction in DBP amongst hypertensives at end of 2 years

  2 years

• Control rates of hypertension at the end of 2 years, control defined as blood pressure less than 140/90

  2 years

• Difference in the Morisky-8 score between the two arms amongst participants who have been prescribed an anti-hypertensive agent at the end of 2 years.

  2 years

• Proportion of diabetics whose fasting blood sugars are controlled, defined as fasting blood glucose <126 at the end of 2 years

  2 years

• Difference in the Morisky-8 score between the two arms amongst participants who have been prescribed a hypoglycemic agent at the end of 2 years.

  2 years

Study Arms (2)

Community health worker

EXPERIMENTAL

Home visits by community health worker to deliver the multi-component behavioural intervention targeted at the individual's hypertension, diabetes or smoking.

Behavioral: Community health worker

Usual care

NO INTERVENTION

Patients will receive usual care in the community

Interventions

Community health worker BEHAVIORAL

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.

Community health worker

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All individuals between the ages of 35 and 70 and residing in the area allotted to the CHW will be offered screening.
• Of the screened individuals, those with at least 1 cardiovascular risk factor (either one of Hypertension (BP\>140/90), Diabetes (FBG \>126) or current daily smoker (self-reported) will be enrolled in the study.

You may not qualify if:

• Individuals who are bed-bound because of acute illness, or have a chronic condition that makes them bed-bound.
• Individuals who refuse consent
• Individuals who do not reside in the community and are only visiting, therefore being unlikely to be available for continuous follow up. Individuals who have stayed less than 6 months in the study area, or whose name is not on the voter list of the area will be excluded.
• Individuals who are not able to participate in the intervention due to significant disabilities, such as blindness, deafness or the intellectually disabled.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

Dalkhola

Dalkhola, West Bengal, 733201, India

Location

Related Publications (1)

• Khetan A, Zullo M, Rani A, Gupta R, Purushothaman R, Bajaj NS, Agarwal S, Madan Mohan SK, Josephson R. Effect of a Community Health Worker-Based Approach to Integrated Cardiovascular Risk Factor Control in India: A Cluster Randomized Controlled Trial. Glob Heart. 2019 Dec;14(4):355-365. doi: 10.1016/j.gheart.2019.08.003. Epub 2019 Sep 12.

  PMID: 31523014 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Smoking; Cardiovascular Diseases

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Sri Krishna M Mohan, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Rishab Gupta, MD

  AIIMS, New Delhi, India

  PRINCIPAL INVESTIGATOR

• Richard Josephson, MS, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 16, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

IN (1)