Community-based Management of Hypertension in Nepal

NCT ID: NCT02428075

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1638 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-02-28

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

FCHV visit-normotensive

Group Type: EXPERIMENTAL

FCHV visit

Intervention Type: BEHAVIORAL

Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages and measure the blood pressure

FCHV no visit-normotensive

Group Type: NO_INTERVENTION

No interventions assigned to this group

FCHV visit-prehypertensive

Group Type: EXPERIMENTAL

FCHV visit

Intervention Type: BEHAVIORAL

Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages and measure the blood pressure

FCHV no visit-prehypertensive

Group Type: NO_INTERVENTION

No interventions assigned to this group

FCHV visit-hypertensive

Group Type: EXPERIMENTAL

FCHV visit

Intervention Type: BEHAVIORAL

Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages and measure the blood pressure

FCHV no visit-hypertensive

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FCHV visit

Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages and measure the blood pressure

Intervention Type: BEHAVIORAL

Other Intervention Names

FCHV Home Visit

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Dinesh Neupane

PhD Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dinesh Neupane, PhD Fellow

Role: PRINCIPAL_INVESTIGATOR

Center for Global Health, Aarhus University, Denmark

Locations

Lekhnath Municipality

Kāski̇̄, Gandaki, Nepal

Countries

Nepal

References

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.

Reference Type: DERIVED

PMID: 34385256 (View on PubMed)

Neupane 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.

Reference Type: DERIVED

PMID: 29241617 (View on PubMed)

Neupane 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.

Reference Type: DERIVED

PMID: 27316539 (View on PubMed)

Other Identifiers

Hypertension-Nepal

Identifier Type: -

Identifier Source: org_study_id