Hypertension,EssentialMUTUNCT04521582
Management of Hypertension Utilizing Trained Community Health Worker in Rural Municipalities of Nepal
A study testing Amlodipine and Lifestyle counselling in people with Hypertension,Essential, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension,Essential
- What is being tested?
- Amlodipine and Lifestyle counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,428 participants
- Where
- 2 sitesNepal
- Study dates
- 27 Apr 2021to 20 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Nepal2 sites
Rupa Rural Municipality
Kāski̇̄, Gandaki, 33700
Biruwa Rural Municipality
Syāṅjā, Gandaki, 33800
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension,Essential
- Being tested
- Amlodipine, Lifestyle counselling
- Keywords
- Hypertension, Community Health Worker, Medication, Amlodipine, Nepal
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
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).
Lifestyle counsellingBehavioural
Female Community Health Volunteer will provide lifestyle counseling at the participant's home
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Experimental | 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. Receives: Drug: Amlodipine; Behavioral: Lifestyle counselling |
| Comparison Group | Active comparator | 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. Receives: Behavioral: Lifestyle counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One year
Secondary outcomes (1)
Percentage of hypertension control (<140/90) among study participants
Systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start27 Apr 2021
- Primary completion20 Apr 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Nepal Development Society
- Responsible party
- Sponsor
- Investigators
- Kunihiro Matsushita, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521582
- Sponsor's protocol ID
- RB00011513
- Other IDs
- 744 - 2019
- Acronym
- MUTU
- Status last verified
- Jul 2022
- First submitted
- 17 Aug 2020
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Hypertension Utilizing Trained Community Health Worker in Rural Municipalities of Nepal (MUTU) Study
- ClinicalTrials.gov ID
- NCT04521582
- Acronym / sponsor ID
- MUTU / RB00011513
- Conditions
- Hypertension,Essential
- Keywords
- Hypertension, Community Health Worker, Medication, Amlodipine, Nepal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,428 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Nepal Development Society
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | Experimental | Drug: Amlodipine, Behavioral: Lifestyle counsellingParticipants 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 comparator | Behavioral: Lifestyle counsellingParticipants 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmlodipineThe 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). | Drug | Active Group |
| Lifestyle counsellingFemale Community Health Volunteer will provide lifestyle counseling at the participant's home | Behavioural | Active Group, Comparison Group |
Primary outcome
Mean change in systolic blood pressure
Time frame: One year
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
Time frame: One year
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.
1 secondary outcome
Percentage of hypertension control (<140/90) among study participants
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kunihiro Matsushita principal investigator
Johns Hopkins Bloomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amlodipine and Lifestyle counselling in people with Hypertension,Essential, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in systolic blood pressure (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.