心房細動患者向けの mHealth アプリケーションである YouControl-AFib の評価
心房細動患者の身体活動を改善するための YouControl-AFib mHealth アプリケーション (パイロット版) の実装
This study is being done to establish the feasibility of performing a clinical trial using a mHealth application named YouControl-AFib designed to improve the cardiovascular health of persons with atrial fibrillation. The study will obtain feedback on the app design to inform future versions and will collect preliminary data to support proof-of-concept and potential effect sizes for future trial design.
調査の概要
詳細な説明
Primary Objective
- To effectively recruit participants for a clinical trial and obtain user feedback on the mHealth app using the Mobile App Rating Scale and focus group sessions.
Secondary Objectives
- To evaluate the impact of the YouControl-AFib mHealth app (pilot version, 3 months of use) on physical activity in persons with atrial fibrillation.
- To obtain several additional functional and disease specific endpoints that will help establish possible effect sizes to be evaluated more formally in subsequent versions of the mHealth application.
- To obtain user feedback on the mHealth app using the Mobile App Rating Scale and focus group sessions.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Wisconsin
-
Madison、Wisconsin、アメリカ、53792
- UW School of Medicine and Public Health
-
-
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
説明
Inclusion Criteria:
- Ability to understand and the willingness to sign a written informed consent document
- Willing to comply with all study procedures and be available for the duration of the study
- SmartPhone capable of pairing with a Fitbit Sense 2 and Fitbit App (Apple iOS 15 and higher or Android 10 or higher)
- Paroxysmal or persistent atrial fibrillation verified by 12-lead electrocardiogram (ECG) or other clinical grade monitoring
- body mass index (BMI) greater than 27
Exclusion Criteria:
- History of permanent atrial fibrillation
- Left ventricular ejection fraction (LVEF) less than 45 percent
- Myocardial infarction, coronary artery bypass grafting, or valve surgery within the last 12 months
- Moderate to severe valve disease
- Inability to participate in a structured exercise program due to musculoskeletal disease
- Already participating in a structured exercise program or achieving guideline directed physical activity
- Planned surgery or procedure during the next three months that limit ability to engage in physical activity
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：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：YouControl-A-Fib アプリを使用している人
|
Participants will use the app for 3 months, includes 1 month phone call with Health Coach |
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 |
|---|---|---|
|
Average Number of Participants Recruited Per Month
時間枠：up to 6 months
|
up to 6 months
|
|
|
Maximum Number of Participants Recruited in a Single Month
時間枠：up to 6 months
|
up to 6 months
|
|
|
Mobile App Rating Scale Score
時間枠：3 months
|
Mobile App Rating Scale contains several subscales that will each be scored on a scale of 1-5; B-functionality, C-aesthetics, and D-information. Higher scores indicate high levels of functionality, aesthetics, and information quality. The overall mean score for all sub-scales is reported here. |
3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in 6-minute Walk Distance (Compared to Baseline for Each Participant) After Using the mHealth App for 3 Months
時間枠：baseline, 3 months
|
baseline, 3 months
|
|
|
Weekly Step Count After Using the mHealth App for Three Months
時間枠：week 1, week 12
|
week 1, week 12
|
|
|
Intentional Activity Time (in One Week) After Using the mHealth App for Three Months
時間枠：week 1, week 12
|
week 1, week 12
|
|
|
General Quality of Life Questionnaire: SF-12 Physical Component Summary Score
時間枠：baseline, 3 months
|
SF-12 measures the impact of health on the participant's life and is scored from 0-100 where higher scores indicates higher health related quality of life. |
baseline, 3 months
|
|
General Quality of Life Questionnaire: SF-12 Mental Component Summary Score
時間枠：baseline, 3 months
|
SF-12 measures the impact of health on the participant's life and is scored from 0-100 where higher scores indicates higher health related quality of life. |
baseline, 3 months
|
|
Patient Health Questionnaire (PHQ-9) Score
時間枠：baseline, 3 months
|
PHQ-9 is a 9-item questionnaire scored on a 4 point likert scale from 0-3 for a total possible range of scores from 0-27. Higher scores indicate increased depression. |
baseline, 3 months
|
|
Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) Score
時間枠：baseline, 3 months
|
AFEQT is a 20-item survey scored on a 7 point likert scale from 1-7 (total possible range of scores is converted to be from 0-100) where higher scores indicate higher effect that atrial fibrillation has on the participant's quality of life. |
baseline, 3 months
|
|
Atrial Fibrillation Symptom Severity (AFSS) Score
時間枠：baseline, 3 months
|
AFSS is a 7-item survey scored on a likert scale from 0-5 for a total possible range of scores from 0-35 where higher scores indicate greater symptom severity. |
baseline, 3 months
|
|
Percent Correct on the Atrial Fibrillation Knowledge Assessment Tool (AFKAT)
時間枠：baseline, 3 months
|
AFKAT is a 21-item true / false assessment that measures knowledge about atrial fibrillation. Correct answers are scored with a 1 for a total possible range of scores from 0-21. Higher scores indicate increased knowledge of atrial fibrillation. Reported here is the percent correct. |
baseline, 3 months
|
|
Life's Essential 8 Score After Using the mHealth App for Three Months
時間枠：baseline, 3 months
|
Life's Essential 8 score (LE8) is a composite score between 0-100 that assesses a participant's adherence to 8 lifestyle recommendations with improve cardiovascular health: diet, physical activity, smoking habits, body mass index, cholesterol, blood glucose, and sleep duration. Higher scores are indicative of higher adherence to healthy lifestyle. |
baseline, 3 months
|
|
Irregular Heart Rate Notifications (in One Week) After Using the mHealth App for Three Months
時間枠：baseline, 3 months
|
baseline, 3 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in ECG-age After Using the mHealth App for Three Months
時間枠：baseline, 3 months
|
Participants will obtain single-lead ECGs at baseline and after three months. The time-voltage data are run through an ECG-AI model for estimating ECG-age. ECG-age is a novel metric developed by investigators at Wake Forest. See reference section for relevant publication describing a similar model. Summary results will be reported as ECG-age in years. |
baseline, 3 months
|
協力者と研究者
捜査官
- 主任研究者：Matthew M Kalscheur, MD、UW School of Medicine and Public Health
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
本研究に関する用語
その他の研究ID番号
- 2024-0954
- A534225 (その他の識別子：UW Madison)
- Protocol Version 8/6/2024 (その他の識別子：UW Madison)
- 1UL1TR002373 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. Every attempt will be made to publish results in peer-reviewed journals.
IPD 共有時間枠
Data from this study may be requested from other researchers 7 years after the completion of the primary endpoint by contacting the PI.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。