MObile Health Intervention to INcrease Activity in Heart Failure Study: A Micro-Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Step count 4 hours after a decision point for micro-randomized messages
研究概览
简要总结
Physical activity is known to help patients with heart failure feel better and live longer though few patients with heart failure are sufficiently active. This study is evaluating whether a mobile health intervention can help patients with heart failure increase physical activity levels and remain active over time. The mobile health intervention consists of three parts: Notifications encouraging physical activity, a digital health coach trained in motivational interviewing, and a mobile application which encourages goal setting and activity monitoring.
详细描述
Hypotheses:
- Push notifications as part of a mobile health intervention will increase immediate (4 hour) physical activity levels among participants with heart failure.
- A multicomponent mobile health intervention will increase physical activity levels at 3 months among participants with heart failure.
- An artificial intelligence (AI) based health coach promoting physical activity will be safe among participants with heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Michigan Medicine patient with a diagnosis of heart failure (HF)
- •Age 18 years and older at screening and able to provide consent
- •New York Heart Association class 2 or 3 HF symptoms
- •Safe for home physical activity as determined by treating clinician
- •Own a smartphone with a compatible Apple or Android operating system
- •Fluent in spoken and written English
排除标准
- •Hospitalized for HF within the prior 6 weeks
- •Orthopedic or neurological condition significantly limiting physical activity
- •Greater than mild cognitive impairment
- •Enrolled in hospice care
- •Severe valvular stenosis
- •Exercise-induced ventricular tachycardia
- •Obstructive left main or proximal left anterior descending coronary artery disease
- •Pulmonary hypertension treated with inhaled or intravenous therapy
- •Currently pregnant or planning to become pregnant
- •Determined to be unsafe for participation as assessed by the investigative team.
研究组 & 干预措施
Mobile application intervention
All participants will have a 1-week baseline period to establish participants pre-intervention step counts.
干预措施: Mobile application intervention (Behavioral)
结局指标
主要结局
Step count 4 hours after a decision point for micro-randomized messages
时间窗: 4 hours after a decision point
次要结局
- Change in mean daily step count from baseline to 3 months(Baseline, 3 months)
- Percentage of transcripts with a recommendation that is deemed unsafe by the study team(3-month intervention)
- Changes in autonomous motivation from baseline to 3 months on the Behavioral Regulation in Exercise Questionnaire version 3 (BREQ-3)(Baseline, 3 months)
- Change in controlled motivation from baseline to 3 months on the Behavioral Regulation in Exercise Questionnaire version 3 (BREQ-3).(Baseline, 3 months)
- Change in mean daily step count by week over the study duration(Weekly up to 3 months (intervention period))
研究者
Jessica Rachel Golbus
Assistant Professor Cardiology
University of Michigan