Heart Failure Self Care Education in Rwanda

NCT07722468 | Not Yet Recruiting

• 1 other identifier: H-45872
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

In Rwanda, patients with heart failure may have low health education about their condition. Heart failure care requires active patient involvement. Self-care of heart failure requires healthy lifestyle, attention to symptoms, proper action when new symptoms develop. However, many patients may choose to stop taking medications when they are feeling well, or disregard new symptoms when they develop and delaying care until their condition is more severe. Educating patients in self-care for heart failure can be achieved by clinical staff with the support of patient handbooks or flip books. Self-care education materials have been developed by the research team in Haiti and have been adapted for Rwanda. This study will use a cluster, stepped wedge design. Patients are already in clusters based on their health facility. The order of implementation will be randomized by the cluster. The primary outcome is heart failure knowledge assessed pre- and post-intervention through a structured survey.

Conditions

Heart Failure

Keywords

Heart failure education; Group education sessions; District hospital clinics; Rwanda

Outcome Measures

Primary Outcomes (1)

• Self-care of Heart Failure (HF)

  This outcome will be assessed with the Self-care of Heart Failure Index (SCHFI). which has subcategories for behaviors, self-monitoring activities and symptom recognition, behaviors based on recognized symptoms, and confidence in behaviors. The SCHFI is a 38-question survey and each question has a 5-point Likert scale response(1= strongly disagree, 5= strongly agree). Total scores can range from 38-190, and higher scores are more favorable.

  Baseline, 4 weeks, 3 months, 6 months

Study Arms (1)

Group-based HF Education

EXPERIMENTAL

A one-day group-based educational intervention about HF will be provided eligible participants,

Other: HF Education

Interventions

HF Education OTHER

The non-communicable disease clinic nurse educator will deliver the education. An illustrated flip book to guide the education. Participants will be given a simplified handout summarizing key educational objectives. These educational tools are translated in Kinyarwanda.

Group-based HF Education

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants living with heart failure followed at non-communicable disease clinics across three district hospitals (DHs) i- Butaro, Kirehe, and Rwinkwavu
• Able to provide informed consent; for minors, able to provide assent with parent or caregiver consent.
• Pediatric participants must be aged ≥10 years; consent will be obtained from a parent or caregiver, with age-appropriate assent from the child.

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• Boston Medical Center: lead
• Inshuti Mu Buzima, Rwanda: collaborator

Study Sites (1)

District Hospitals Butaro, Kirehe, and Rwinkwavu

Kigali, Rwanda

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Gene F Kwan, MD MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gene F Kwan, MD MPH

CONTACT

617 638 8760; genekwan@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A hybrid type 1 effectiveness-implementation design will be used to test the effect of an educational intervention on Self-Care of HF knowledge, HF clinical status and other clinical outcomes while observing and collecting implementation outcomes. Specifically, a cluster, stepped-wedge (non randomized) trial that will test the effect of an educational intervention will be conducted.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)