미세 랜덤 화 시험에 적응합니다 (ADAPT MRT)
The goal of this study is to collect quantitative and qualitative data that can be used to optimize the HeartSteps mHealth intervention for physical activity. The current version of the intervention is intended to help patients with heart disease increase and maintain their physical activity long-term. To accomplish this goal, a 3-month pilot micro-randomized trial (MRT) will be conducted with 60 patients who are currently completing or have recently completed phase II cardiac rehabilitation (CR).
The core of the study participation is the use of the HeartSteps intervention over the course of 3 months. This includes wearing the Fitbit Charge activity tracker during waking hours and using the HeartSteps intervention to support their efforts to be active. The HeartSteps intervention consists of two sets of intervention components: (1) components intended to improve participants' affective associations with physical activity, including activity suggestions designed to to trigger positive feelings and associate them with being active, and prompts to bring their awareness to intrinsically motivating aspects of being active; and (2) components that target reflective self-regulatory processes, including graphs for self-monitoring, prompts to plan activity, and weekly activity goals. How exactly, and how much, participants will use HeartSteps will not be prescribed since our goal is to understand naturalistic trajectory of engagement with the intervention.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Pedja Klasnja, Ph.D. in Information Science
- 전화번호: 734-763-3581
- 이메일: klasnja@umich.edu
연구 장소
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- 모병
- University of Michigan
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연락하다:
- Pedja Klasnja, Ph.D.
- 전화번호: 734-763-3581
- 이메일: klasnja@umich.edu
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부수사관:
- Jessica Golbus, M.D.
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부수사관:
- Brahmajee Nallamothu, M.D.
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부수사관:
- Mark Newman, Ph.D.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Must be a patient within the Michigan Medicine clinical system with data available in the electronic health record after January 1, 2020.
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Age > 18
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Owns and is a daily user of an Android or iPhone smartphone with study supported operating software.
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Understands English to enable informed consent, completion of study-related surveys, and compliance with study notifications.
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Will be completing within 30 days or have completed in the last 30 days the cardiac rehabilitation program at Michigan Medicine based on one of the following indications:
- Coronary artery disease (including acute coronary syndromes and stable angina) following percutaneous coronary intervention (PCI)
- Coronary artery disease following coronary artery bypass surgery (CABG)]
- Valve repair or replacement (either surgical or percutaneous)
- Coronary artery disease or an acute coronary syndrome not requiring revascularization
Exclusion Criteria:
- Orthopedic or neurological condition limiting ability to actively engage in moderate intensity physical activity (e.g., brisk walking)
- Greater than mild cognitive impairment
- Wrist too large to wear an activity tracker comfortably. This will be assessed by asking participants "If they have ever had difficulty wearing a watch in the past due to the band being too small."
- Currently receiving palliative care and/or in hospice care
- Severe valvular stenosis or regurgitation
- Unrevascularized left main coronary artery disease (> 50% obstruction on angiography) or proximal left anterior descending disease (>70% obstruction on angiography).
- Exercise-induced ventricular tachycardia
- Cardiac arrest within the prior 6 months
- New York Heart Association (NYHA) class III or IV heart failure
- Pulmonary arterial hypertension treated with inhaled or intravenous pulmonary hypertension-specific therapy
- Ejection fraction <40%
- Determined to be unsafe for participation in this program as assessed by a clinical nurse or investigative team.
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: Intervention
Participants receive the HeartSteps mHealth intervention for 3 months to support and increase physical activity. Components include:
Participants wear a Fitbit Charge tracker to monitor activity, synced to their MyDataHelps account. The intervention aims to optimize engagement and physical activity levels. |
HeartSteps is an innovative mobile health (mHealth) app designed for cardiac rehabilitation patients. The app features dynamic push notifications, daily and weekly surveys to capture psychosocial data, and an in-app dashboard that provides feedback on activity levels, goal progress, and reminders. Integrated with a Fitbit Charge tracker, HeartSteps emphasizes behavioral changes through engaging features. The intervention is personalized to meet individual needs and preferences, enhancing patient engagement and promoting sustained physical activity. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Weekly number of minutes of moderate to vigorous physical activity
기간: Baseline, 12 weeks
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The primary outcome of the study is number of weekly minutes of moderate to vigorous physical activity (MVPA), as assessed by the Fitbit Charge 6 activity tracker. Primary analysis will assess the difference in MVPA between the baseline week and the last (i.e. 12th) week of the study. |
Baseline, 12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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3-hour step count
기간: 12 weeks
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Number of steps, as assessed by the Fitbit Charge 6 activity tracker, measured in the three-hour window following the randomization of activity suggestions. This outcome will be assessed after each decision point for the micro-randomized activity suggestions. Each participant will have two decision points per day for the duration of the study. |
12 weeks
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Daily step count
기간: 12 weeks
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Number of steps per day, assessed by the Fitbit Charge 6 activity tracker. |
12 weeks
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Affective exercise experiences (AFFEXX) scale
기간: Baseline, 12 weeks
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A validated 36-item self-report instrument that assesses participants' affective associations with physical activity. AFFEXX scale will be administered weekly for the duration of the study. The main analysis of this outcome will assess pre-post differences in the AFFEXX score between baseline and 12th week. |
Baseline, 12 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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. .