Community-based intervention for blood pressure reduction in Nepal (COBIN trial)

Study protocol for a cluster-randomized controlled trial

Dinesh Neupane, Craig S. McLachlan, Bo Christensen, Arjun Karki, Henry Baker Perry, Per Kallestrup

Research output: Contribution to journalArticle

Abstract

Background: Hypertension contributes to a significant burden of cardiovascular disease in low- and middle-income countries; however, responses are inadequate because of a lack of conclusive evidence on population-based approaches to hypertension control. Methods/design: The objective of the present study is to determine the effect of family-based home health education and blood pressure monitoring by trained female community health volunteers. The primary outcome is change in mean systolic blood pressure. A community-based, open-masked, two-armed, cluster-randomized trial will be conducted in Lekhnath Municipality of Nepal. The municipality is divided into 15 administrative clusters. Randomization will be conducted for 14 clusters: 7 for the intervention arm and 7 for the control arm. The participants were recruited from a prevalence study conducted earlier. On the basis of population proportion size, 929 individuals for the intervention group and 709 individuals for the control group will participate in the study. Due to the nature of the study, study participants are not compensated or insured. As part of the blood pressure intervention, trained female community health volunteers will conduct home visits for health education and blood pressure measurement. The primary outcomes will be modeled by using multiple linear regression analysis. Discussion: This project will be an investigation of a community-based intervention to control blood pressure in countries with limited resources. The study will provide detailed information on the burden of blood pressure and also whether treatment targets are being met. Moreover, evidence will be provided on the future role of female community health volunteers for hypertension management in Nepal. The lessons learned from this study may also be replicated in other rural areas of Nepal and elsewhere in the world with similar settings. Trial registration: ClinicalTrials.gov NCT02428075. Registered on 23 April 2015.

Original languageEnglish (US)
Article number292
JournalTrials
Volume17
Issue number1
DOIs
StatePublished - Jun 18 2016

Fingerprint

Nepal
Clinical Protocols
Randomized Controlled Trials
Blood Pressure
Volunteers
Hypertension
Health Education
Health
House Calls
Random Allocation
Population Density
Linear Models
Cardiovascular Diseases
Cross-Sectional Studies
Regression Analysis
Control Groups
Population

Keywords

  • Community health worker
  • Community-based
  • Female Community Health Volunteers
  • Hypertension
  • Nepal
  • Non-communicable diseases
  • Primary Health Care

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Community-based intervention for blood pressure reduction in Nepal (COBIN trial) : Study protocol for a cluster-randomized controlled trial. / Neupane, Dinesh; McLachlan, Craig S.; Christensen, Bo; Karki, Arjun; Perry, Henry Baker; Kallestrup, Per.

In: Trials, Vol. 17, No. 1, 292, 18.06.2016.

Research output: Contribution to journalArticle

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