Community Health Workers-led Multicomponent Intervention for Hypertension Control in Rwanda

NCT06959134 | Completed

• 1 other identifier: 695/CMHS IRB/2024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will involve patients, families and healthcare providers in the following ways

1. 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. 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. 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.

Conditions

Hypertension

Keywords

Community Health Workers; Multicomponent Intervention; Hypertension; Randomized clinical trials; Control

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Data will be collected from the 3 to 6 months of data collection

Other Outcomes (1)

• Cost, effectiveness and cost effectiveness of community health workers led multi components intervention

  Will be evaluated retrospectively for the past 12 months following data collection from the intervention and control group

Study Arms (2)

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.

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

Interventions

The intervention will be mainly focused on the lifestyle modification and medication adherence, and self monitoring at home BEHAVIORAL

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.

An experimental arm will be composed with 100 patients with uncontrolled blood pressure

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rwanda: lead

Study Sites (1)

Gasabo and Bugesera health centers

Kigali, Rwanda

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Richard KALISA, PhD

  University of Rwanda/School of Public Health

  STUDY DIRECTOR

• Clarisse Marie Claudine SIMBI, PhD

  University of Rwanda/School of Public Health

  STUDY DIRECTOR

• Kevin NWANNA, PhD

  University of Rwanda/ School of Public Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 6, 2025
• Study Start: December 1, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 30, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)