Rheumatic Heart Disease
Conditions
Keywords
Rheumatic heart disease, SHIELD
Brief summary
This study aims to improve follow-up care after positive rheumatic heart disease (RHD) screening in Northern Uganda. It will identify barriers and co-develop an enhanced ACT+ strategy, then evaluate its effectiveness in increasing linkage to confirmatory echocardiography, along with its adoption, acceptability, and feasibility. Secondary outcomes include time to diagnosis, initiation of treatment, and factors influencing implementation.
Interventions
OTHERThe ACT+ Strategy
The Active Community Case Management Tool (ACT) is a cloud-based, dynamic RHD case management tool developed by CCHMC in partnership with global stakeholders, including UHI and the RRCU. ACT provides real-time data on patient status, clinical outcomes, and care processes, supporting both individual patient management (electronic medical record functions) and system-level quality improvement (registry and dashboard functions).
Sponsors
Children's Hospital Medical Center, Cincinnati
Uganda Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
This study employs a sequential, mixed-methods design with two phases corresponding to Aims 1 and 2. Aim 1 - Human-Centered Design (HCD) (Year 1) Aim 1 will use a theory-informed HCD framework to adapt the ACT registry and develop implementation strategies tailored to the Ugandan context. Aim 2 - Hybrid Effectiveness-Implementation Trial (Year 2) Aim 2 will evaluate ACT+ using a mixed-methods, hybrid effectiveness-implementation trial with a cluster randomized controlled design. Sixteen primary healthcare facilities (clusters) will be randomized in a 1:1 ratio to receive ACT+ (intervention arm, n=8) or standard of care (control arm, n=8). The 9-month intervention period will be followed by quantitative and qualitative evaluation.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Community Members * 18 years of age or older * Received a positive ADUNU echocardiographic screening result within the past 24 months OR parent/legal guardian of a minor who received a positive ADUNU echocardiographic screening result within the past 24 months Inclusion Criteria: Providers * Employed at an ADUNU-participating facility or confirmatory echo facilities at the time of study * Holds a designated ADUNU role (nurse screener, confirmatory provider, or referral support staff) or is involved in RHD screening, diagnosis or care * Ability to provide informed consent in Acholi, Luo, or English Inclusion Criteria: Regional RHT ACT Nurse Coordinator * Employed as a Regional ACT Nurse at the time of study * Has familiarity with ADUNU program * Ability to provide informed consent in Acholi, Luo, or English Inclusion Criteria: District Health Office Team Members and District RHD Focal Persons * Employed at District Health Office within an ADUNU-participating district * Has familiarity with ADUNU program * Ability to provide informed consent in Acholi, Luo, or English
Exclusion criteria
* No formal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facility-level linkage to confirmation rate | 9 months | The proportion of individuals with a positive ADUNU screening result who complete confirmatory echocardiography within the 9-month intervention period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time (days) from positive screen to confirmatory echocardiography | 9 months | % providers entering \>90% of screening records OR completing all monthly outreach activities |
Countries
Uganda
Contacts
CONTACTIsabella Brigham
PRINCIPAL_INVESTIGATORAndrea Beaton
Children's Hospital Medical Center, Cincinnati
Outcome results
None listed