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
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Isabella Brigham
- 電話番号：513-517-1307
- メール：isabella.aspromonte@cchmc.org
研究場所
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Kampala、ウガンダ
- Uganda Heart Institute
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コンタクト：
- Jafes Pulle
- 電話番号：0784936334
- メール：jpulle@rrcuganda.org
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主任研究者：
- Jafes Pulles
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ふるい分け
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし：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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介入なし：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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アクティブコンパレータ：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Facility-level linkage to confirmation rate
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Time (days) from positive screen to confirmatory echocardiography
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Andrea Beaton、Children's Hospital Medical Center, Cincinnati
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。