Community-based Management of Hypertension in Nepal (COBIN)

February 23, 2017 updated by: Dinesh Neupane, University of Aarhus

Protocol for Community-based Intervention for Blood Pressure Reduction in Nepal: a Community-based Cluster Randomized Controlled Trial

Hypertension contributes to significant burden of cardiovascular diseases (CVDs) in low and middle-income countries; however responses to CVDs are inadequate particularly due to lack of conclusive evidence on population based approach to hypertension control. This is a community based cluster randomized trial involving family based health education through female community health volunteers in Nepal. People ≥25 years of age and who are listed in the voter list 2006 of Electoral Commission of Nepal who were either hypertensive, pre-hypertensive or normotensive are eligible for eligible for participation in the study. A computer generated random codes will be used to divide clusters into treatment and control arm. FCHVs will conduct family based health education and blood pressure measurements in the treatment arm vs not any interventions in control arm. Independent assessors will conduct the baseline and end line assessment of the intervention. Intention to treat analysis and per protocol analysis will be used in analysis to detect significant differences between treatment and control group participants at baseline and follow up. Student t-tests for normally distributed variables and chi-squared tests for categorical variables will be used. In the event that randomization do not control for differences between the treatment and control groups on baseline characteristics, the investigators will statistically control for those differences in subsequent analysis of program effects. The final outcome will be modeled by using multiple linear regressions analysis. The investigators hope that if the intervention outcomes shows positive effects in treatment arm, this approach can be adopted into the existing health care delivery system in Nepal. Assessing the FCHVs' ability may further contribute to developing a policy that can be scaled-up to a national level. The lessons learned from this project may also be replicated in rural areas and similar settings elsewhere in the world.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1638

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Gandaki
      • Kaski, Gandaki, Nepal
        • Lekhnath Municipality

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • People ≥25 years of age and who are listed in the voter list of 2006 and those participated in our prevalence study are eligible for inclusion in the baseline survey. - Person who give consent to participate in our intervention study,
  • does not have any plan to migrate from Lekhnath Municipality for at least 1 year,
  • non-pregnant women and
  • personal who are not severely ill will be included as eligible participants.

Exclusion Criteria:

  • No consent
  • Pregnant women
  • Severely Il
  • Plan for migration for the study municipality within 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FCHV visit-normotensive
Behavioral: FCHV visit
Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages and measure the blood pressure
Other Names:
  • FCHV Home Visit
No Intervention: FCHV no visit-normotensive
Experimental: FCHV visit-prehypertensive
Behavioral: FCHV visit
Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages and measure the blood pressure
Other Names:
  • FCHV Home Visit
No Intervention: FCHV no visit-prehypertensive
Experimental: FCHV visit-hypertensive
Behavioral: FCHV visit
Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages and measure the blood pressure
Other Names:
  • FCHV Home Visit
No Intervention: FCHV no visit-hypertensive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in mean systolic blood pressure in normotensive, pre-hypertensive and hypertensive populations
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Dinesh Neupane, PhD Fellow, Center for Global Health, Aarhus University, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

April 23, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hypertension-Nepal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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