An interventional study of The intervention will be mainly focused on the lifestyle modification and medication adherence, and self monitoring at home in Hypertension, sponsored by University of Rwanda. Completed at 1 site in Rwanda. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by University of Rwanda · Not applicable, Interventional, and Supportive care
This study will involve patients, families and healthcare providers in the following ways
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.
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
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 200 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
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Exclusion Criteria:
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.
Behavioral: The intervention will be mainly focused on the lifestyle modification and medication adherence, and self monitoring at home
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
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.
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
Time frame: This will be measured at 3 , 6 and 12 months from the time of data collection
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.
Time frame: Data will be collected from the 3 to 6 months of data collection
Cost, effectiveness and cost effectiveness of community health workers led multi components intervention
QALYs will be the primary measurement of efficacy outcomes. The incremental cost-effectiveness ratio (ICER) between the multicomponent intervention and normal care will be computed by dividing the cost difference by the difference in efficacy in quality-adjusted life years (QALYs). One-way sensitivity analysis will be used to address methodological and individual parameter uncertainties. A tornado diagram analysis will be conducted to determine the relative weight of each variable in terms of total uncertainty. Parameters for sensitivity analyses will be chosen based on systematic fluctuations around the basic model's parameters or disparities between trial data and published studies. The parameters investigated by one-way sensitivity analysis will include time horizon, discount rate for costs and QALYs, transition probabilities, relative risk of HTN events, and HTN. When 95% confidence intervals are available, they will be used to calculate ranges for 1-way sensitivity analyses.
Time frame: Will be evaluated retrospectively for the past 12 months following data collection from the intervention and control group
Plan to share: 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
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University of Rwanda