Explainable AI for Predicting Hospital Admissions in Heart Failure: ExplAIn-HF (ExplAIn-HF)
The goal of this observational study is to develop and validate an XAI based model that predicts HF events and identifies modifiable con-tributing factors, and to evaluate the added value of integrating high frequency smartwatch data compared to usual care in patients with heart failure. The main objectives of the study are:
- To develop and validate an XAI based model that predicts HF events and identifies modifiable contributing factors, and to evaluate the added value of integrating high frequency smartwatch data compared to usual care. In the Netherlands usual care includes remote monitoring of heartrate, blood pressure, weight and symptoms.
- To include insights of the smartwatch into activity patterns, impact on quality of life (KCCQ-12), and patient satisfaction with net promoter score (NPS).
Participants will wear a smartwatch for six months and perform an I-lead ecg with the smartwatch weekly.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
-
-
Enschede、オランダ
- Medisch Spectrum Twente
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patients will be selected after HF hospitalization at three hospitals: Medisch Spectrum Twente (MST), Hospital Group Twente (ZGT), and Deventer hospital.
説明
Inclusion Criteria:
- Adult HF patients
- NYHA class II, or NYHA III
- Rehospitalization for HF
- Usual care with active participation in the telemonitoring program "Zorg Bij Jou" (ZBJ)
- Possession of an iPhone 11 or newer and compatible with the study apps
Exclusion Criteria:
- Lack of digital literacy or inability to use the device
- Not capable to sign consent
- Referral to hospice
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
|
心不全患者
|
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 |
|---|---|---|
|
Heart failure (HF) event
時間枠：From enrollment to the end of follow-up at 6 months
|
HF event is defined as:
|
From enrollment to the end of follow-up at 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Activity patterns
時間枠：From enrollment to the end of follow-up at 6 months
|
Activity patterns measured with the smartwatch |
From enrollment to the end of follow-up at 6 months
|
|
Quality of life (QoL)
時間枠：Measured at baseline and at the end of follow-up at 6 months. The Kansas City Cardiomyopathy Questionnaire is scored on a scale of 0 to 100; higher scores indicate better health.
|
QoL measured with Kansas City Cardiomyopathy Questionnaire-12 |
Measured at baseline and at the end of follow-up at 6 months. The Kansas City Cardiomyopathy Questionnaire is scored on a scale of 0 to 100; higher scores indicate better health.
|
|
Net promotor score
時間枠：At the end of follow-up at 6 months
|
Net promotor score measures how likely patients are to recommend this technology to others. This score ranges from 0 to 10. Higher values indicate a greater likelihood of recommending to others. |
At the end of follow-up at 6 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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。