Skip to main content
OpenTrials
Completed

NCT Number: NCT02428075

Community-based Management of Hypertension in Nepal

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lekhnath Municipality

Kāski̇̄, Gandaki, Nepal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FCHV visit

Behavioral

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

Primary outcomes

  1. Change in mean systolic blood pressure in normotensive, pre-hypertensive and hypertensive populations

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Acronym: COBIN

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 28, 2015
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.