Back to search results

Observational Study on Enhanced Supports for Rheumatic Heart Disease

This study is looking at ways to help children and adults with Rheumatic Heart Disease (RHD) better stick to their Secondary Antibiotic Prophylaxis (SAP) treatment. SAP is a regular antibiotic treatment used to prevent further heart damage. The study will test a program delivered by Community Health Workers (CHWs) that includes reminders, education, and help connecting to care. Researchers want to see if these enhanced supports improve how well people take their SAP in Brazil and Timor-Leste. The study is open to adults with RHD, guardians of children with RHD, and children aged 12-17 with RHD. The main goal is to see if these CHW-led supports are practical and well-received, and if they increase SAP adherence over 12 months. The current recruitment status is unclear.

Study design
This is an observational study involving about 308 participants. It uses a pre-post design to evaluate the impact of CHW-led supports on SAP adherence.
What's involved
Participants will have their SAP adherence tracked for 12 months before and after the intervention. Demographic data and RHD history will be collected at enrollment.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the feasibility and acceptability of the intervention at 24 months, and SAP adherence at 12 months post-intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07666048

Adapting Enhanced Supports to Improve Patient Adherence to Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease

Not Yet Recruiting
Not specifiedAll AgesObservational
Children's Hospital Medical Center, Cincinnati
~308 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:CHW Delivered SAP Adherence Supports

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility and acceptability of the adapted CHW-led SAP support intervention
Measured over 24 months

Conditions

Rheumatic Heart Disease in Children

Explore related trials

Rheumatic Heart Disease

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Sarah de Loizaga, Medical Doctor · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati
  • Andrea Beaton, Medical Doctor · STUDY_DIRECTOR · Children's Hospital Medical Center, Cincinnati

Who to contact

Principal Investigator, Assistant Professor
[email protected]
5136364432
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Adults living with rheumatic heart disease (RHD): age ≥18 years; diagnosed with RHD; prescribed secondary antibiotic prophylaxis (SAP)
Guardians of children living with RHD: age ≥18 years; caregiver/guardian of a child aged 5-17 years with diagnosed RHD who is prescribed SAP
Children living with RHD: age 12-17 years; diagnosed with RHD; prescribed SAP
Community health workers (CHWs): age ≥18 years; associated with a healthcare center providing care to patients with RHD
Healthcare workers (HCWs): age ≥18 years; employed at a healthcare center providing care to patients with RHD; able to provide informed consent in English or the local language

Exclusion

Adults living with RHD: medical contraindication to SAP; inability to provide informed consent (e.g., significant cognitive or communication impairment precluding participation)
Guardians of children living with RHD: child has a medical contraindication to SAP; inability to provide informed consent
Children living with RHD: medical contraindication to SAP; inability to provide informed assent (e.g., significant cognitive or communication impairment precluding participation)
Community health workers: none
Healthcare workers: none

What this trial measures

  • Feasibility and acceptability of the adapted CHW-led SAP support intervention24 months

    Proportion of participants reporting the intervention as acceptable (e.g., via standardized acceptability surveys) Proportion of intended intervention components successfully implemented (fidelity/adoption)