Clinical trial NCT06959134: Community Health Workers-led Multicomponent Intervention for Hypertension Control in Rwanda
Official title: Community Health Workers-led Multicomponent Intervention for Hypertension Control in Rwanda: A Cluster Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Community Health Workers
Multicomponent Intervention
Hypertension
Randomized clinical trials
Control
Lead sponsor: University of Rwanda
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.
2. 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.
3. 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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The proportion of patients with controlled hypertension and mean blood pressure between intervention and control group
timeFrame: This will be measured at 3 , 6 and 12 months from the time of data collection
Secondary outcomes:
measure: Facilitators and barriers in the implementation of community health workers-led multicomponents intervention to control hypertension among uncontrolled hypertensive patients
timeFrame: Data will be collected from the 3 to 6 months of data collection
Other outcomes:
measure: Cost, effectiveness and cost effectiveness of community health workers led multi components intervention
timeFrame: Will be evaluated retrospectively for the past 12 months following data collection from the intervention and control group
Locations:
city: Kigali
country: Rwanda
facility: Gasabo and Bugesera health centers
Study officials:
affiliation: University of Rwanda/School of Public Health
name: Richard KALISA, PhD
role: STUDY_DIRECTOR
affiliation: University of Rwanda/School of Public Health
name: Clarisse Marie Claudine SIMBI, PhD
role: STUDY_DIRECTOR
affiliation: University of Rwanda/ School of Public Health
name: Kevin NWANNA, PhD
role: STUDY_DIRECTOR
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