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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension,Essential
• Intervention / Treatment: Drug: Amlodipine; Behavioral: Lifestyle counselling

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.

• Study Type: Interventional
• Enrollment (Actual): 1428
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Gandaki
    • Kaski, Gandaki, Nepal, 33700
      • Rupa Rural Municipality
    • Syangja, Gandaki, Nepal, 33800
      • Biruwa Rural Municipality

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Group; 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.	Drug: Amlodipine; 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).; Behavioral: Lifestyle counselling; Female Community Health Volunteer will provide lifestyle counseling at the participant's home
Active Comparator: Comparison Group; 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.	Behavioral: Lifestyle counselling; Female Community Health Volunteer will provide lifestyle counseling at the participant's home

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of hypertension control (<140/90) among study participants	Systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg	One year

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Nepal Development Society
• Investigators: Principal Investigator: Kunihiro Matsushita, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Actual): April 20, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Hypertension; Nepal; Medication; Amlodipine; Community Health Worker
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Amlodipine
• Other Study ID Numbers: RB00011513; 744 - 2019 (Other Identifier: Nepal Health Research Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No