Management of Hypertension Utilizing Trained Community Health Worker in Rural Municipalities of Nepal
MUTU
2 other identifiers
interventional
1,428
1 country
2
Brief Summary
The investigators will evaluate whether a system involving Female Community Health Volunteers (FCHVs) and facility-based community health workers (FB-CHWs) of Health Post (Auxiliary Health Workers, Auxiliary Nurse Midwives and Health Assistant) can contribute to improving hypertension care in rural Nepal. This study will be conducted in Rupa (active group) and Biruwa (comparison group) Rural Municipality of Gandaki province and enroll at least 736 hypertensive adults (322 in Rupa Rural Municipality and 414 in Biruwa Rural Municipality) who are aged 25-70 years, not taking antihypertensive medication, not pregnant and not breastfeeding, free of prior cardiovascular disease, chronic kidney disease, and diabetes. In Rupa Municipality, eligible participants will be able to receive amlodipine, one of the most frequently used antihypertensive medications, from FB-CHWs at Health Posts and five times (including baseline and end of study) of lifestyle counseling by FCHVs, whereas participants in Biruwa Municipality will receive the usual care plus three times (including baseline and end of study) of lifestyle counseling by FCHVs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2020
CompletedFirst Posted
Study publicly available on registry
August 20, 2020
CompletedStudy Start
First participant enrolled
April 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2022
CompletedJuly 29, 2022
July 1, 2022
12 months
August 17, 2020
July 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean change in systolic blood pressure
To assess the longitudinal association of the intervention with changes in blood pressure over time, linear mixed effect models with a three-level hierarchical approach will be used.
One year
Mean change in diastolic blood pressure
To assess the longitudinal association of the intervention with changes in blood pressure over time, linear mixed effect models with a three-level hierarchical approach will be used.
One year
Secondary Outcomes (1)
Percentage of hypertension control (<140/90) among study participants
One year
Study Arms (2)
Active Group
EXPERIMENTALParticipants will be first screened for their blood pressure and asked a few questions to determine eligibility. For eligible participants, FCHV will visit within \~1 week and measure blood pressure again. If found high, the participant will be referred to the nearest Health Post. At the Health Posts, if FB-CHWs confirms the diagnosis of hypertension, they will prescribe amlodipine 5 mg/d according to the study protocol and ask the patient to return in \~2 weeks. If blood pressure is controlled (\<140/90 mmHg) after \~2 weeks, FB-CHWs will refill amlodipine 5 mg/d for 3 months. If not, FB-CHWs will increase the dose to 10 mg/d and follow up in \~2 weeks. If still not controlled with amlodipine 10 mg, FB-CHWs will refer the patient to the Regional Hospital in Pokhara. In addition, FCHVs will visit patients' homes 3 times (at 3-, 6-, and 9-month), provide lifestyle counseling, and follow up the adherence to hypertension treatment.
Comparison Group
ACTIVE COMPARATORParticipants will be first screened for their blood pressure and asked a few questions to determine eligibility. For eligible participants, FCHV will visit within a week or so and measure the blood pressure again. If found high, the participant will be referred to a healthcare facility ("the usual care") which can diagnose and manage hypertension. In addition, FCHVs will visit patients' homes once (around 3-month), provide lifestyle counseling, and follow up the adherence to hypertension treatment.
Interventions
The facility-based community health worker will receive protocol-driven training to initiate amlodipine for hypertensive patients. These patients will receive lifestyle counseling by Female Community Health Volunteer through home visits (5 times \[including baseline and end of the study\] in the active municipality and 3 times \[including baseline and end of the study\] in the control municipality).
Female Community Health Volunteer will provide lifestyle counseling at the participant's home
Eligibility Criteria
You may qualify if:
- Between 25-70 years old
- Systolic blood pressure 140-179 mmHg or diastolic blood pressure 90-119 mmHg
- Do not have a plan to leave the study municipality within a year
You may not qualify if:
- Use of antihypertensive medication in the last two weeks
- History of stroke, heart attack, heart failure, or chronic kidney disease
- History of diabetes meritus
- Pregnant or any plan to be pregnant in a year
- Breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Rupa Rural Municipality
Kāski̇̄, Gandaki, 33700, Nepal
Biruwa Rural Municipality
Syāṅjā, Gandaki, 33800, Nepal
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kunihiro Matsushita
Johns Hopkins Bloomberg School of Public Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2020
First Posted
August 20, 2020
Study Start
April 27, 2021
Primary Completion
April 20, 2022
Study Completion
July 20, 2022
Last Updated
July 29, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share