Community-based Management of Hypertension in Nepal
COBIN
Protocol for Community-based Intervention for Blood Pressure Reduction in Nepal: a Community-based Cluster Randomized Controlled Trial
1 other identifier
interventional
1,638
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2015
CompletedFirst Posted
Study publicly available on registry
April 28, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedFebruary 24, 2017
February 1, 2017
1.1 years
April 23, 2015
February 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in mean systolic blood pressure in normotensive, pre-hypertensive and hypertensive populations
1 year
Study Arms (6)
FCHV visit-normotensive
EXPERIMENTALFCHV no visit-normotensive
NO INTERVENTIONFCHV visit-prehypertensive
EXPERIMENTALFCHV no visit-prehypertensive
NO INTERVENTIONFCHV visit-hypertensive
EXPERIMENTALFCHV no visit-hypertensive
NO INTERVENTIONInterventions
Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages and measure the blood pressure
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- No consent
- Pregnant women
- Severely Il
- Plan for migration for the study municipality within 1 year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lekhnath Municipality
Kāski̇̄, Gandaki, Nepal
Related Publications (3)
Paudel S, Subedi N, McLachlan CS, Smith BJ, Kallestrup P, Neupane D. Active commuting and leisure-time physical activity among adults in western Nepal: a cross-sectional study. BMJ Open. 2021 Aug 12;11(8):e051846. doi: 10.1136/bmjopen-2021-051846.
PMID: 34385256DERIVEDNeupane D, McLachlan CS, Mishra SR, Olsen MH, Perry HB, Karki A, Kallestrup P. Effectiveness of a lifestyle intervention led by female community health volunteers versus usual care in blood pressure reduction (COBIN): an open-label, cluster-randomised trial. Lancet Glob Health. 2018 Jan;6(1):e66-e73. doi: 10.1016/S2214-109X(17)30411-4.
PMID: 29241617DERIVEDNeupane D, McLachlan CS, Christensen B, Karki A, Perry HB, Kallestrup P. Community-based intervention for blood pressure reduction in Nepal (COBIN trial): study protocol for a cluster-randomized controlled trial. Trials. 2016 Jun 18;17(1):292. doi: 10.1186/s13063-016-1412-3.
PMID: 27316539DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dinesh Neupane, PhD Fellow
Center for Global Health, Aarhus University, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Fellow
Study Record Dates
First Submitted
April 23, 2015
First Posted
April 28, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2016
Study Completion
February 1, 2017
Last Updated
February 24, 2017
Record last verified: 2017-02