- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07606131
Testing a Registry-Based Strategy (ACT+) to Reduce Loss to Follow-Up in Rheumatic Heart Disease Screening in Uganda (SHIELD 2)
Developing and Testing a Registry-Enabled Strategy (ACT+) to Reduce Loss to Follow-Up Between Screening and Confirmation of Rheumatic Heart Disease in Uganda
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Isabella Brigham
- 전화번호: 513-517-1307
- 이메일: isabella.aspromonte@cchmc.org
연구 장소
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Kampala, 우간다
- Uganda Heart Institute
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연락하다:
- Jafes Pulle
- 전화번호: 0784936334
- 이메일: jpulle@rrcuganda.org
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수석 연구원:
- Jafes Pulles
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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 exclusion criteria beyond inability to provide informed consent. Individuals with significant cognitive or communication impairment precluding interview participation will not be enrolled.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Inspiration/Discovery (1A)
Semi-structured qualitative interviews with screen-positive community members (or parents/guardians of community members) and ADUNU providers to characterize multilevel barriers and facilitators.
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간섭 없음: Ideation/Design (1B)
A structured participatory design workshop with a 15-member HCD expert panel, followed by iterative co-design sessions to produce finalized ACT+ features and workflows.
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활성 비교기: Healthcare Facilities will receive ACT+ Intervention
The ACT+ strategy consists of three coordinated, registry-enabled implementation components co-designed and refined through the Aim 1 HCD process. Component 1: Digitized Pre-Confirmation Registry Entry and Patient Tracking ACT+ will enable entry of screen-positive individuals into the ACT registry at the time of positive screen (prior to confirmatory diagnosis). Component 2: Patient Tracing and Reminder System ACT+ will support automated and semi-automated outreach to screen-positive who have not yet completed confirmatory echocardiography. Component 3: Audit and Feedback for Providers and Facilities ACT+ dashboards will provide facility-level, real-time feedback on LTFU rates, confirmation completion, and the screening-to-SAP initiation cascade. |
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).
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간섭 없음: Control: Standard of Care
Facilities in the control arm will continue current standard ADUNU practice: screen-positive individuals receive verbal and written referral information to one of three confirmatory sites immediately following screening.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Facility-level linkage to confirmation rate
기간: 9 months
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The proportion of individuals with a positive ADUNU screening result who complete confirmatory echocardiography within the 9-month intervention period.
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9 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time (days) from positive screen to confirmatory echocardiography
기간: 9 months
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% providers entering >90% of screening records OR completing all monthly outreach activities
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9 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Andrea Beaton, Children's Hospital Medical Center, Cincinnati
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .