HypertensionNCT06959134
Community Health Workers-led Multicomponent Intervention for Hypertension Control in Rwanda
A study testing The intervention will be mainly focused on the lifestyle modification and medication adherence, and self monitoring at home in people with Hypertension, run by University of Rwanda at 1 site in Rwanda.
Trial summary
This study will involve patients, families and healthcare providers in the following ways 1. Patients; The main study participants will be patients with uncontrolled hypertension who are currently managed at the health center level. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- The intervention will be mainly focused on the lifestyle modification and medication adherence, and self monitoring at home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRwanda
- Study dates
- 1 Dec 2024to 30 Jan 2025
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Blood Pressure above or equal to 130/80
- Male and female aged 21 years old and above
- Patients attending NCD clinics in the eight selected Rwanda health centers during the period of data collection.
Who cannot join
- Blood Pressure below 130/80 mmHg
- Patients without other adult living in the same house
- Hypertensive patients with active systemic illness (fever, known liver disease), clinically unstable heart failure, advanced CKD
- Patients deemed mentally unfit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Health Workers-led Multicomponent Intervention for Hypertension Control in Rwanda: A Cluster Randomized Controlled Trial.
This study will involve patients, families and healthcare providers in the following ways
- Patients; The main study participants will be patients with uncontrolled hypertension who are currently managed at the health center level. After being enrolled in the study the patients will be asked to follow the recommendations given by healthcare providers and community health workers during the study period(Intervention group follow up of one year), and will be required to continuously respect the standard appointment at the health center and in addition to this they will be visited by community health workers at their household at least once per month, and during this visit they will have a health education basically on medication adherence and lifestyle modifications including adopting a culture of healthy physical activity for better control of hypertension not only this but community health worker will take one measurement on Blood pressure in between the month in addition to the usual measurement taken at the health center at the time of the regular appointment. And then on this side everytime the community health worker will visit a patient , family member will be requested to be present for helping to remind the patient the healthy habit discussed as most of these patients are old requiring a close follow up.
- Family; Will play a key role in helping the patient to adopt new healthy habit depending on the preference and reminding the patient on adhering to medications regimen but also notify the community health worker or the research if there is any adverse health outcome occured during the research period.
- Health care provider; This will involves healthcare providers on different level mainly the Community health workers and Nurses working in Non Communicable disease Clinic at the health centers.
Read more
Methods: A cluster randomized controlled trial will be randomly assigned to four health centers in the intervention arm and another four health centers for routine health care hypertensive care, enrolling 25 patients with uncontrolled hypertension per health center, equivalent to 200 total sample size.
Participants: Patients with uncontrolled hypertension followed-up from health centers non-communicable disease (NCD) clinics in eight health centers(Gihogwe, Kagugu, Remera and Bumbogo in Gasabo and Nyamata, Mayange, Gashora and Ntarama health center in Bugesera district.
Interventions: Participants in the intervention arm will receive an integrated community health worker led- multicomponent intervention (CHW led-MCI) which includes CHW-led home-based intervention including health coaching, monthly home blood pressure monitoring and feedback, lifestyle changes and medication adherence. While those in the control arm received routine health center nurse led management of hypertension in Non-communicable diseases (NCD) clinics ('standard of care').
Outcomes: Effectiveness of the CHW led-MCI will be evaluated through three main research objectives and their outcomes. To evaluate if Integrated CHW led-MCI can control hypertension will be measured through primary outcome clinical outcomes are (i) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the CHW led-MCI intervention and control groups at 3, 6, 9 and 12 months and secondary on lowing blood pressure, mean blood pressure will be reported, dietary sodium consumption, glucose, BMI as well as improving medication adherence between the CHW led-MCI intervention and control groups at 3, 6, 9 and 12 months (Objective 1). We will explore the facilitators and barriers in the implementation of CHW-led MCI to control hypertension at Rwandan health centers from the patient, health center nurses, facility managers, and policymakers perspectives (objective 2). Finally, we will evaluate the cost, effectiveness, and cost-effectiveness of CHW-led MCI implementation outcomes to inform policymakers on a scale out of the intervention (objective 3).
Study utility: This study will help policymakers to understand if the recent task-shifting of nurses to manage hypertension at the health center level is working as well as generate additional evidence on CHW-led intervention to improve hypertension control at the community/household level in Rwanda and other low-resource countries.
Read the detailed description
This randomised controlled trials will be conducted in eight health centers, and will have three main sub studies:
The first substudy will mainly evaluate the community health workers multicomponent intervention, which will assist the routine care patients receive from the health centers provided by nurses to control hypertension, especially those patients with uncontrolled hypertension. These will include home visits, health education, monitoring blood pressure at home and physical activity of these patients.
Substudy two; this substudy will mainly consist of the evaluation of facilitators and barriers which may be implicated in the community health workers multicomponent intervention to control hypertension among hypertensive patients. This part will be a qualitative study where the investigator will evaluate the opinion of patients , NCD clinic nurses at health centers, health center managers but also policymakers perspectives in the ministry of health about the multicomponent intervention. And each group of participants will mention the possible facilitators and barriers which may make this intervention to run smoothly and therefore benefit patients.
Sub study three; This part will evaluate the financial burden means that A health system perspective system will be used to determine the cost, effectiveness, and cost-effectiveness of CHW-led multicomponent intervention on uncontrolled hypertensive patients attending Rwanda health centers. Participants' data will be used to estimate CHWs-led MCI effects and HTN control. It's main objective will be to determine the cost, effectiveness, and cost-effectiveness of CHW-led multicomponent intervention on hypertensive patients attending Rwanda health centers
- Conditions
- Hypertension
- Being tested
- The intervention will be mainly focused on the lifestyle modification and medication adherence, and self monitoring at home
- Keywords
- Community Health Workers, Multicomponent Intervention, Hypertension, Randomized clinical trials, Control
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention will be mainly focused on the lifestyle modification and medication adherence, and self monitoring at homeBehavioural
In the intervention arm, study participants will received health education mainly based on lifemodification changes which will include; eating healthy diet, adopting healthy physical exercise, smoking cessation , moderate alcohol consumption and stress amanagement), and will be taugh on medication adherence, but also on self monitoring of blood pressure for detecting the variation and react accordingly.
| Study group | Role | What they receive |
|---|---|---|
| An experimental arm will be composed with 100 patients with uncontrolled blood pressure | Experimental | In the intervention arm patients with uncontrolled hypertension will be getting routine care form the NCD clinic at the health center and in addition to this , they will receive an assistance from the community health workers where they will give the patients health education mainly on lifestyle modifications, medication adherence and self monitoring of blood pressure at home for detecting the variability and report them accordingly. Receives: Behavioral: The intervention will be mainly focused on the lifestyle modification and medication adherence, and self monitoring at home |
| In this arm which will be no intervention, there will be100 patients with uncontrolled hypertension | No intervention | In this arm patient will receive the routine care from the health center NCD clinic and at the end of the study data collection period , data will be compared to those blood pressure measurement from the intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with controlled hypertension and mean blood pressure between intervention and control group
the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the CHW led-MCI intervention and control groups at 3, 6, 9 and 12 months and secondary on lowing blood pressure, mean blood pressure will be reported, BMI as well as improving medication adherence between the CHW led-MCI intervention and control groups at 3, 6, 9 and 12 months
Measured: This will be measured at 3 , 6 and 12 months from the time of data collection
Secondary outcomes (1)
Facilitators and barriers in the implementation of community health workers-led multicomponents intervention to control hypertension among uncontrolled hypertensive patients
We will explore the facilitators and barriers in the implementation of CHW-led MCI to control hypertension at Rwandan health centers from the patient, health center nurses, facility managers, and policymakers perspectives.
The outcome will be measured using an interview guide to conduct interview and FGD. Interview guides (IDIs and FGDs will be developed in accordance with previous literature reviews and research on CHW-led MCI).The PI will collect the data, assisted by a trained research assistant. All interviews will held in a nearby, quiet, and convenient room for the study participants. All interviews will be audio-recorded and transcribed verbatim in Kinyarwanda (the local language) to English. However, the work will be re-evaluated again by the PI and double-checked by the research supervisors. The transcripts will be loaded into the NVivo 11 software for coding and data analysis.We will use these coding to find connections between themes and identify overarching principles.
Measured: Data will be collected from the 3 to 6 months of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 Dec 2024
- Primary completion10 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rwanda
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MWISENEZA Innocent, Rwanda Military Hospital
- Investigators
- Richard KALISA, PhD, Study director, University of Rwanda/School of Public HealthClarisse Marie Claudine SIMBI, PhD, Study director, University of Rwanda/School of Public HealthKevin NWANNA, PhD, Study director, University of Rwanda/ School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959134
- Sponsor's protocol ID
- 695/CMHS IRB/2024
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To ensure the privacy of study participants, the individual participant data will not be shared but also as one of the requirements of the clinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Workers-led Multicomponent Intervention for Hypertension Control in Rwanda: A Cluster Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06959134
- Acronym / sponsor ID
- 695/CMHS IRB/2024
- Conditions
- Hypertension
- Keywords
- Community Health Workers, Multicomponent Intervention, Hypertension, Randomized clinical trials, Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of RwandaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 6 May 2025 (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.
This study will involve patients, families and healthcare providers in the following ways
- Patients; The main study participants will be patients with uncontrolled hypertension who are currently managed at the health center level. After being enrolled in the study the patients will be asked to follow the recommendations given by healthcare providers and community health workers during the study period(Intervention group follow up of one year), and will be required to continuously respect the standard appointment at the health center and in addition to this they will be visited by community health workers at their household at least once per month, and during this visit they will have a health education basically on medication adherence and lifestyle modifications including adopting a culture of healthy physical activity for better control of hypertension not only this but community health worker will take one measurement on Blood pressure in between the month in addition to the usual measurement taken at the health center at the time of the regular appointment. And then on this side everytime the community health worker will visit a patient , family member will be requested to be present for helping to remind the patient the healthy habit discussed as most of these patients are old requiring a close follow up.
- Family; Will play a key role in helping the patient to adopt new healthy habit depending on the preference and reminding the patient on adhering to medications regimen but also notify the community health worker or the research if there is any adverse health outcome occured during the research period.
- Health care provider; This will involves healthcare providers on different level mainly the Community health workers and Nurses working in Non Communicable disease Clinic at the health centers.
Methods: A cluster randomized controlled trial will be randomly assigned to four health centers in the intervention arm and another four health centers for routine health care hypertensive care, enrolling 25 patients with uncontrolled hypertension per health center, equivalent to 200 total sample size.
Participants: Patients with uncontrolled hypertension followed-up from health centers non-communicable disease (NCD) clinics in eight health centers(Gihogwe, Kagugu, Remera and Bumbogo in Gasabo and Nyamata, Mayange, Gashora and Ntarama health center in Bugesera district.
Interventions: Participants in the intervention arm will receive an integrated community health worker led- multicomponent intervention (CHW led-MCI) which includes CHW-led home-based intervention including health coaching, monthly home blood pressure monitoring and feedback, lifestyle changes and medication adherence. While those in the control arm received routine health center nurse led management of hypertension in Non-communicable diseases (NCD) clinics ('standard of care').
Outcomes: Effectiveness of the CHW led-MCI will be evaluated through three main research objectives and their outcomes. To evaluate if Integrated CHW led-MCI can control hypertension will be measured through primary outcome clinical outcomes are (i) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the CHW led-MCI intervention and control groups at 3, 6, 9 and 12 months and secondary on lowing blood pressure, mean blood pressure will be reported, dietary sodium consumption, glucose, BMI as well as improving medication adherence between the CHW led-MCI intervention and control groups at 3, 6, 9 and 12 months (Objective 1). We will explore the facilitators and barriers in the implementation of CHW-led MCI to control hypertension at Rwandan health centers from the patient, health center nurses, facility managers, and policymakers perspectives (objective 2). Finally, we will evaluate the cost, effectiveness, and cost-effectiveness of CHW-led MCI implementation outcomes to inform policymakers on a scale out of the intervention (objective 3).
Study utility: This study will help policymakers to understand if the recent task-shifting of nurses to manage hypertension at the health center level is working as well as generate additional evidence on CHW-led intervention to improve hypertension control at the community/household level in Rwanda and other low-resource countries.
Detailed description
This randomised controlled trials will be conducted in eight health centers, and will have three main sub studies:
The first substudy will mainly evaluate the community health workers multicomponent intervention, which will assist the routine care patients receive from the health centers provided by nurses to control hypertension, especially those patients with uncontrolled hypertension. These will include home visits, health education, monitoring blood pressure at home and physical activity of these patients.
Substudy two; this substudy will mainly consist of the evaluation of facilitators and barriers which may be implicated in the community health workers multicomponent intervention to control hypertension among hypertensive patients. This part will be a qualitative study where the investigator will evaluate the opinion of patients , NCD clinic nurses at health centers, health center managers but also policymakers perspectives in the ministry of health about the multicomponent intervention. And each group of participants will mention the possible facilitators and barriers which may make this intervention to run smoothly and therefore benefit patients.
Sub study three; This part will evaluate the financial burden means that A health system perspective system will be used to determine the cost, effectiveness, and cost-effectiveness of CHW-led multicomponent intervention on uncontrolled hypertensive patients attending Rwanda health centers. Participants' data will be used to estimate CHWs-led MCI effects and HTN control. It's main objective will be to determine the cost, effectiveness, and cost-effectiveness of CHW-led multicomponent intervention on hypertensive patients attending Rwanda health centers
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| An experimental arm will be composed with 100 patients with uncontrolled blood pressure | Experimental | Behavioral: The intervention will be mainly focused on the lifestyle modification and medication adherence, and self monitoring at homeIn the intervention arm patients with uncontrolled hypertension will be getting routine care form the NCD clinic at the health center and in addition to this , they will receive an assistance from the community health workers where they will give the patients health education mainly on lifestyle modifications, medication adherence and self monitoring of blood pressure at home for detecting the variability and report them accordingly. |
| In this arm which will be no intervention, there will be100 patients with uncontrolled hypertension | No intervention | –In this arm patient will receive the routine care from the health center NCD clinic and at the end of the study data collection period , data will be compared to those blood pressure measurement from the intervention group |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Blood Pressure above or equal to 130/80
- Male and female aged 21 years old and above
- Patients attending NCD clinics in the eight selected Rwanda health centers during the period of data collection.
Key exclusion criteria (4 listed)
- Blood Pressure below 130/80 mmHg
- Patients without other adult living in the same house
- Hypertensive patients with active systemic illness (fever, known liver disease), clinically unstable heart failure, advanced CKD
- Patients deemed mentally unfit.
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 |
|---|---|---|
| The intervention will be mainly focused on the lifestyle modification and medication adherence, and self monitoring at homeIn the intervention arm, study participants will received health education mainly based on lifemodification changes which will include; eating healthy diet, adopting healthy physical exercise, smoking cessation , moderate alcohol consumption and stress amanagement), and will be taugh on medication adherence, but also on self monitoring of blood pressure for detecting the variation and react accordingly. | Behavioural | An experimental arm will be composed with 100 patients with uncontrolled blood pressure |
Primary outcome
The proportion of patients with controlled hypertension and mean blood pressure between intervention and control group
Time frame: This will be measured at 3 , 6 and 12 months from the time of data collection
the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the CHW led-MCI intervention and control groups at 3, 6, 9 and 12 months and secondary on lowing blood pressure, mean blood pressure will be reported, BMI as well as improving medication adherence between the CHW led-MCI intervention and control groups at 3, 6, 9 and 12 months
1 secondary outcome
Facilitators and barriers in the implementation of community health workers-led multicomponents intervention to control hypertension among uncontrolled hypertensive patients
Time frame: Data will be collected from the 3 to 6 months of data collection
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 6 May 2025.
- Individual participant dataSharing planned: No. To ensure the privacy of study participants, the individual participant data will not be shared but also as one of the requirements of the clinicalTrials.gov
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Richard KALISA, PhD study director
University of Rwanda/School of Public Health
Clarisse Marie Claudine SIMBI, PhD study director
University of Rwanda/School of Public Health
Kevin NWANNA, PhD study director
University of Rwanda/ School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention will be mainly focused on the lifestyle modification and medication adherence, and self monitoring at home in people with Hypertension, run by University of Rwanda at 1 site in Rwanda.
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 4 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 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. 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?
The proportion of patients with controlled hypertension and mean blood pressure between intervention and control group (time frame: This will be measured at 3 , 6 and 12 months from the time of data collection). 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 6 May 2025.