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Community-based intervention for blood pressure reduction in Nepal (COBIN trial): study protocol for a cluster-randomized controlled trial.

ABSTRACT: 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.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.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.ClinicalTrials.gov NCT02428075 . Registered on 23 April 2015.

SUBMITTER: Neupane D

PROVIDER: S-EPMC4912718 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Community-based intervention for blood pressure reduction in Nepal (COBIN trial): study protocol for a cluster-randomized controlled trial.

Neupane Dinesh D McLachlan Craig S CS Christensen Bo B Karki Arjun A Perry Henry B HB Kallestrup Per P

Trials 20160618 1

<h4>Background</h4>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.<h4>Methods/design</h4>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 s ...[more]

PMID: 27316539

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Project description:BACKGROUND:Type 2 diabetes is one of the fastest emerging chronic diseases in low- and middle-income countries. Population-based approaches, such as involvement of lay health workers offering culturally appropriate diabetes health promotion, may be the blueprint for the management of type 2 diabetes. This study aims to examine the effectiveness of a family-based home health education intervention on type 2 diabetes provided by female community health volunteers (FCHVs) in a semi-urban area of Lekhnath Municipality of Nepal. METHODS:The COmmunity-Based INtervention for management of Diabetes in Nepal (COBIN-D) trial is a community-based, open-label, two-armed, cluster-randomized trial with seven randomly selected intervention and seven wait-list control clusters. A total of 112 subjects with type 2 diabetes will be recruited from the intervention clusters and 112 subjects from the wait-list control clusters. Based on the Health Belief Model and Social Support Theory, a 12-month family-based lifestyle intervention will be administered through FCHVs. Wait-list control clusters will continue to manage their glycemic condition as usual and their intervention will be delayed for 12 months. Participants will be measured at the beginning of the study and 12 months later. The primary outcome measure of the study will be difference in mean change (from baseline to 1 year) in fasting blood glucose between the two study arms. Impacts will be estimated using intention-to-treat analysis. DISCUSSION:The COBIN-D is the first study investigating the effect of family-based home health education and screening on blood sugar levels in adults by FCHVs at community level in Nepal. The perspective of this study is to develop and implement, in collaboration with the community, a community-based, culturally sensitive diabetes prevention and control program. It is anticipated that the study can act as a feasible and affordable tool for evidence-based integrated care for improvement of diabetes management and outcomes in Nepal as well as in other low- and middle-income countries. TRIAL REGISTRATION:ClinicalTrials.gov, Identifier: NCT03304158 . Registered retrospectively on 03 October 2017.

Dataset Information

Community-based intervention for blood pressure reduction in Nepal (COBIN trial): study protocol for a cluster-randomized controlled trial.

Publications

Community-based intervention for blood pressure reduction in Nepal (COBIN trial): study protocol for a cluster-randomized controlled trial.

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