심방세동 환자를 위한 모바일 헬스 애플리케이션 YouControl-AFib 평가
심방세동 환자의 신체 활동을 개선하기 위한 YouControl-AFib mHealth 애플리케이션(파일럿 버전) 구현
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Wisconsin
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Madison, Wisconsin, 미국, 53792
- UW School of Medicine and Public Health
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: YouControl-A-Fib 앱을 사용하는 사람들
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Participants will use the app for 3 months, includes 1 month phone call with Health Coach |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Average Number of Participants Recruited Per Month
기간: up to 6 months
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up to 6 months
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Maximum Number of Participants Recruited in a Single Month
기간: up to 6 months
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up to 6 months
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Mobile App Rating Scale Score
기간: 3 months
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in 6-minute Walk Distance (Compared to Baseline for Each Participant) After Using the mHealth App for 3 Months
기간: baseline, 3 months
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baseline, 3 months
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Weekly Step Count After Using the mHealth App for Three Months
기간: week 1, week 12
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week 1, week 12
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Intentional Activity Time (in One Week) After Using the mHealth App for Three Months
기간: week 1, week 12
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week 1, week 12
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General Quality of Life Questionnaire: SF-12 Physical Component Summary Score
기간: baseline, 3 months
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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
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General Quality of Life Questionnaire: SF-12 Mental Component Summary Score
기간: baseline, 3 months
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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
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Patient Health Questionnaire (PHQ-9) Score
기간: baseline, 3 months
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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
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Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) Score
기간: baseline, 3 months
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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
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Atrial Fibrillation Symptom Severity (AFSS) Score
기간: baseline, 3 months
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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
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Percent Correct on the Atrial Fibrillation Knowledge Assessment Tool (AFKAT)
기간: baseline, 3 months
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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
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Life's Essential 8 Score After Using the mHealth App for Three Months
기간: baseline, 3 months
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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
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Irregular Heart Rate Notifications (in One Week) After Using the mHealth App for Three Months
기간: baseline, 3 months
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baseline, 3 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in ECG-age After Using the mHealth App for Three Months
기간: baseline, 3 months
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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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Matthew M Kalscheur, MD, UW School of Medicine and Public Health
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
기타 연구 ID 번호
- 2024-0954
- A534225 (기타 식별자: UW Madison)
- Protocol Version 8/6/2024 (기타 식별자: UW Madison)
- 1UL1TR002373 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
Data from this study may be requested from other researchers 7 years after the completion of the primary endpoint by contacting the PI.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .