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Management of Hypertension Utilizing Trained Community Health Worker in Rural Municipalities of Nepal (MUTU)

Primary Purpose

Hypertension,Essential

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Amlodipine
Lifestyle counselling
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension,Essential focused on measuring Hypertension, Community Health Worker, Medication, Amlodipine, Nepal

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Sites / Locations

  • Rupa Rural Municipality
  • Biruwa Rural Municipality

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active Group

Comparison Group

Arm Description

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Percentage of hypertension control (<140/90) among study participants
Systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg

Full Information

First Posted
August 17, 2020
Last Updated
July 27, 2022
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Nepal Development Society
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1. Study Identification

Unique Protocol Identification Number
NCT04521582
Brief Title
Management of Hypertension Utilizing Trained Community Health Worker in Rural Municipalities of Nepal
Acronym
MUTU
Official Title
Management of Hypertension Utilizing Trained Community Health Worker in Rural Municipalities of Nepal (MUTU) Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
July 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Nepal Development Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Despite a large body of evidence on the effectiveness of hypertension treatment in reducing cardiovascular morbidity and mortality, the control rate of hypertension is low in many low and middle-income countries. The shortage of skilled workforce diagnosing and managing hypertension is one of the major barriers. A promising option is to involve community health workers (CHWs) in hypertension care, who have shown promising results for improving maternal and child health. However, the evidence on whether CHWs can diagnose and treat hypertension under the supervision of a physician has not been systematically tested. Thus, this study will evaluate whether existing Facility Based-Community Health Workers (FB-CHWs) and Female Community Health Volunteers (FCHVs) of the Ministry of Health can safely and effectively diagnose hypertension and initiate/maintain protocol-based hypertension treatment. This study will be conducted in Rupa (active group) and the Biruwa (comparison group) Rural Municipality of Gandaki province. All adults aged 25-70 years of age who reside in the Rupa and Biruwa municipalities are eligible for the initial screening by data enumerators of the Nepal Development Society (NeDS). Only eligible participants who meet the inclusion criteria will participate in the study. Rupa Rural Municipality will allow the initiation of antihypertensive medication (amlodipine) by FB-CHW at Health Posts under the supervision of a study physician. Biruwa Rural Municipality will follow usual care, which is a referral to healthcare facilities currently providing hypertension care. FCHVs will provide lifestyle counseling and follow up the adherence to hypertension treatment three times in Rupa Rural Municipality and once in Biruwa Rural Municipality.FCHV in Rupa Rural Municipality will make three home visits (at 3, 6, and 9 months) whereas FCHV in Biruwa Rural Municipality will make one home visit after 3 months of baseline. The end of the study survey will be carried out after one year by FCHV and NeDS data enumerators. The primary study outcome is a net change in systolic blood pressure among hypertensive participants 12-months after confirming hypertension in the active vs. the comparison group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential
Keywords
Hypertension, Community Health Worker, Medication, Amlodipine, Nepal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1428 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Group
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Comparison Group
Arm Type
Active Comparator
Arm Description
Participants 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.
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counselling
Intervention Description
Female Community Health Volunteer will provide lifestyle counseling at the participant's home
Primary Outcome Measure Information:
Title
Mean change in systolic blood pressure
Description
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.
Time Frame
One year
Title
Mean change in diastolic blood pressure
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Percentage of hypertension control (<140/90) among study participants
Description
Systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria 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 Exclusion criteria 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kunihiro Matsushita
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rupa Rural Municipality
City
Kaski
State/Province
Gandaki
ZIP/Postal Code
33700
Country
Nepal
Facility Name
Biruwa Rural Municipality
City
Syangja
State/Province
Gandaki
ZIP/Postal Code
33800
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
No

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Management of Hypertension Utilizing Trained Community Health Worker in Rural Municipalities of Nepal

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