Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change in Moderate to Vigorous Physical Activity (MVPA)
研究概览
简要总结
The purpose of this study is to evaluate early preliminary efficacy of the eMotion intervention in US adults who have experienced a first cardiac event and participating in phase II cardiac rehabilitation.
This study will evaluate early efficacy and evaluate the cognitive processes as intervention response variables. Investigators will also examine the relationships between emotion regulation and other cognitive processes and symptoms (threat and stress, cognition and motivation), symptoms [depression, anxiety, pain, sleep, and fatigue]), and health related quality of life among adults enrolled in cardiac rehabilitation after a first cardiac event.
详细描述
Aim 1: Evaluate early preliminary efficacy of the eMotion intervention
Research hypothesis 1. Compared with adults randomized to active healthy living attention control and usual care control groups, adults randomized to eMotion will have greater improvement in these outcomes over time:
1.1. Improved minutes of moderate to vigorous physical activity 1.2. Symptom improvement (depression, anxiety, pain, sleep, and fatigue) 1.3. Health related quality of life.
Aim 2: Evaluate the cognitive processes as intervention response variables.
Research hypothesis 2. Compared with adults randomized to active healthy living attention control and usual care control groups, adults randomized to eMotion will have:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •First time major cardiac event as documented in medical record;
- •enrolled in cardiac rehabilitation phase II program;
- •living independently; and
- •at least mild symptoms of depression and/or anxiety (determined by standardized measure cutpoints).
排除标准
- •does not speak English;
- •major Axis 1 psychiatric diagnosis (e.g. schizophrenia);
- •terminal cancer; and
- •legally blind
研究组 & 干预措施
eMotion
The eMotion intervention is based on feasibility testing of the successful in-person program with critical refinement to improve accessibility. eMotion has undergone subsequent content validity testing with intervention development, self-management, cardiovascular health, and health information technology delivery experts. eMotion teaches a carefully selected repertoire of emotion regulation strategies well suited for aging rural adults following a first cardiac event in tandem with usual cardiac rehabilitation. The intervention helps patients recognize their emotions, balance emotional and physical wellbeing, and implement emotion regulation strategies effectively. Intervention provided in addition to usual cardiac rehabilitation.
干预措施: eMotion (Behavioral)
Healthy living active control
Healthy living strategies based on American Heart Association education. Intervention provided in addition to usual cardiac rehabilitation.
干预措施: Healthy Living Active Control (Behavioral)
Usual care
Usual cardiac rehabilitation with no additional intervention.
结局指标
主要结局
Change in Moderate to Vigorous Physical Activity (MVPA)
时间窗: 1 week trials at baseline, 12 weeks, 20 weeks, and 52 weeks
Minutes spent in MVPA
次要结局
- Change in Depression Symptoms(Baseline to 12 weeks, 20 weeks, and 52 weeks)
- Change in Pain Symptoms(Baseline to 12 weeks, 20 weeks, and 52 weeks)
- Change in Sleep efficiency(Baseline to 12 weeks, 20 weeks, and 52 weeks)
- Change in Fatigue Symptoms(Baseline to 12 weeks, 20 weeks, and 52 weeks)
- Change in Anxiety Symptoms(Baseline to 12 weeks, 20 weeks, and 52 weeks)
研究者
Kelly L. Wierenga
Assistant Professor, Nursing
Indiana University