A Novel Psychological-behavioral Intervention to Promote Physical Activity After Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 24 weeks
研究概览
简要总结
The focus of this study is to test the efficacy of a 12-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks), compared to post-acute coronary syndrome (ACS) treatment as usual, in a randomized trial of 280 post-ACS patients with low baseline physical activity.
详细描述
The investigators are proposing a study that will focus on testing the efficacy of a PP-MI intervention, with additional twice text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks) in post-ACS patients. The investigators will enroll 280 post-ACS patients, who will take part in either a 12-week intervention (with 24 weeks of supplemental text messages), or receive post-ACS treatment as usual.
In this project, the investigators hope to do the following:
- Examine the efficacy of a 12-week, phone-delivered PP-MI intervention for individuals with ACS on physical activity-related outcomes, as compared to the treatment as usual group.
- Assess the intervention's impact on psychological (e.g. positive affect), functional (e.g. physical function), and behavioral (e.g. overall adherence) outcomes.
- Explore the intervention's impact on markers of cardiovascular health (e.g., cardiac biomarkers), as well as major adverse cardiac events/readmissions.
Participants will be screened and enrolled during admission for an ACS. They will be provided with a accelerometer to monitor their physical activity for one week prior to their first in-person visit. At their first visit, they will answer questionnaires related to psychological and physical health and functioning, have their blood pressure and weight measured, and provide a fasting blood sample. Upon confirmation of adequate physical activity, participants will be randomized to receive the PP-MI intervention or treatment as usual.
Participants in the intervention will be provided a treatment manual, an activity tracker, and other treatment materials. The intervention will be introduced, and the first exercise will be assigned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and treating study staff will be aware of the participant's treatment condition. However, follow-up assessments will be performed by a study staff member that is masked to the participant's treatment condition.
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ACS (myocardial infarction or unstable angina)
- •Suboptimal physical activity (score of < 6 on the Medical Outcomes study Specific Adherence Scale item related to physical activity)
排除标准
- •Cognitive deficits (assessed via a 6-item cognitive screening tool)
- •Medical conditions likely to lead to death within 6 months.
- •Moderate-severe depression (Patient Health Questionnaire-9 [PHQ-9] score ≥15)
- •Inability to participate in physical activity due to another medical condition (e.g., arthritis)
- •Inability to read, write, or speak in English
- •Inability to receive text-messages
- •Current participation in another intervention or program that has been designed to promote well-being or physical activity
研究组 & 干预措施
Positive Psychology + Motivational Interviewing
Each week, participants in the PP-MI intervention group will complete a PP activity and work towards a physical activity goal, then complete a phone session with a study trainer. Each phone session will include PP and goal setting portions. In the PP portion, the study trainer will (a) review the week's PP exercise, (b) discuss the rationale of the next week's PP exercise through a guided review of the PP-MI manual, and (c) assign the next week's PP exercise. In the goal-setting portion, the trainer will (a) review the participant's physical activity goal from the prior week, (b) discuss techniques for improving physical activity (e.g. tracking activity), and (c) help the participant to set a physical activity goal for the next week. Participants also will receive supplemental text messages throughout the 12 weeks of the intervention and during the initial follow-up period (Week 13-24).
干预措施: Positive Psychology + Motivational Interviewing (Behavioral)
Treatment as Usual
Participants in the treatment as usual (TAU) arm will not receive any specific intervention, though they will be free to receive any post-ACS treatment.
结局指标
主要结局
Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 24 weeks
时间窗: Measured for 7 days at baseline and 24 weeks
MVPA will be measured via an accelerometer and recorded in mean minutes/day.
次要结局
- Change in Light Intensity Activity(Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks)
- Change in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items)(Baseline, 12 weeks, 24 weeks, 48 weeks)
研究者
Jeff C. Huffman, MD
Director, Cardiac Psychiatry Research Program
Massachusetts General Hospital