Supportive Training After Cardiac Rehabilitation Including Virtual Engagement: The STRIVE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Step counts
研究概览
简要总结
The proposed research seeks to determine whether virtual coaching and social support focusing on key social cognitive factors will be an effective strategy for maintaining physical activity (PA) after completing cardiac rehabilitation (CR). Despite the well-documented benefits of CR, only 15-50% of individuals continue to exercise 6 months after completing CR.4-6 Thus, after 36 sessions (typically 12 weeks), many patients are left without the support necessary to sustain physical activity (PA) and prevent adverse secondary cardiac events. Though previous research has explored interventions to sustain PA after CR, many studies have been lacking in a theoretical basis, objective measurement of PA, measurement, and analysis of psychosocial and social cognitive factors, and long-term impact on clinical outcomes. Low-cost, pragmatic approaches to maintaining PA after CR is urgently needed for older adults, and virtual technologies offer promising solutions to promote adherence to PA. The three specific aims of the project are to: 1) determine the effect of virtual coaching and social support on adherence to PA (measured by objective step counts) in the intervention vs. control groups; secondary measures will be amount of sedentary time, functional fitness, and self-reported exercise; 2) determine the effect of virtual coaching and social support on psychosocial and social cognitive factors in the intervention vs. control groups; 2a) evaluate the extent to which psychosocial and social cognitive factors mediate the effect of the intervention on PA adherence; 3) examine differences in cardiovascular (CVD) risk factors (blood pressure, lipids, HbA1c, BMI) between groups.
详细描述
The investigators propose a randomized clinical trial in which the "STRIVE" control group will receive the Trainerize mobile app for (1) daily self monitoring of exercise, blood pressure, and weight; (2) education via weekly text messages; and (3) assigned monthly videos on various health topics. The "STRIVE +" intervention group will receive the same app for self-monitoring and education via text messages as the control group PLUS individually-tailored virtual coaching with goal-setting and social support/networking. Our specific aims are to:
Aim 1: Determine the effect of virtual coaching and social support on adherence to physical activity (PA; measured by objective step counts) in the intervention vs. control groups; secondary measures will be amount of sedentary time, functional fitness, and self-reported exercise.
Hypothesis 1: The intervention group will have more PA steps and self-reported exercise, less sedentary time, and higher functional fitness compared to the control group.
Aim 2: Determine the effect of virtual coaching and social support on psychosocial and social cognitive factors in the intervention vs. control groups.
Hypothesis 2: The intervention group will have lower depression/loneliness and higher self-efficacy/perceived social support compared to the control group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study population: We will recruit 286 older adults who are 55 years and older with qualifying diagnoses for cardiac rehabilitation (CR).
- •Inclusion Criteria:
- •≥ 55 years of age
- •History of CVD that qualified patient for CR (myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, heart failure, valve replacement, etc.)
- •Adherence (>50% of sessions for ≥1 month) to outpatient Phase II CR and pending completion
排除标准
- •Participation in Phase III CR (optional extended CR after outpatient Phase II CR for those who pay out-of-pocket)
- •Cognitive impairment (per Mini-Cog assessment tool with score 0-2)
- •Lack of English or Spanish proficiency/literacy
- •Clinical conditions including:
- •Unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm or symptomatic anemia
- •Active infection
- •Uncontrolled hypertension: resting systolic >180 mmHg, diastolic >100 mmHg
- •Decompensated heart failure, NYHA Class III-IV
- •Current unstable angina
- •2nd or 3rd degree heart block or exercise induced arrhythmias
研究组 & 干预措施
Mobile App Alone
Mobile app control group. Exposure time will be similar between participants in both the intervention and control groups as both will have: (1) continuous access to the app for self-monitoring of exercise, blood pressure, and weight; (2) weekly "push" text messages with access to a library of educational content for learning that is self-paced on the app over 6 months; and (3) assigned 1 video per month on a variety of health topics related to older adults via the app that match exposure time (approximately 20-30 minutes) with the intervention group. The videos will be created or resourced from reputable organizations. The coach will send weekly short one-way messages on goals, self-management, etc. that the intervention group will also receive. The 1-way messages will be derived from a bank of 210 secondary prevention messages for CVD (PA, nutrition, stress management, heart disease facts, etc.).
Mobile app + Social
The intervention group will also receive Virtual coaching. The coach will evaluate goals, progress, facilitators (use of the buddy system) and challenges with an emphasis on forming healthy PA habits that will be sustained long-term over the life course. Social support: For the social support component, we will provide ground rules for communication (e.g., positive posts, use of "likes", comments, etc.). Groups will be comprised of 4-6 participants with consecutive recruitment.
干预措施: Virtual Coaching and social support (Behavioral)
结局指标
主要结局
Step counts
时间窗: At baseline, 3, and 6 months
The primary outcome of step counts will be collected from the Fitbit. Baseline measurements will be compared to repeated measures over time. Patients will wear the Fitbit for the 1-week run-in period before randomization then will wear it for 2 weeks at the end of month 3 and again at the end of month 6.
次要结局
- Physical Activity, barriers and sedentary time: Rapid Assessment of Physical Activity scale(Baseline, 3, 6, and 12 months)
- Physical Activity, barriers and sedentary time: Exercise Barriers Scale(Baseline, 3, 6, and 12 months)
- Physical Activity, barriers and sedentary time: Self-reported sedentary time(Baseline, 3, 6, and 12 months)
- Functional fitness tests: sit-to-stand(Baseline, 3, 6, and 12 months)
- Functional fitness tests: 2 minute step test(Baseline, 3, 6, and 12 months)
- Functional fitness tests: dumbbell curl test(Baseline, 3, 6, and 12 months)
- Psychosocial factors: Depression(Baseline, 3, 6, and 12 months)
- Psychosocial factors: Loneliness(Baseline, 3, 6, and 12 months)
- Social cognitive factors: Self-efficacy(Baseline, 3, 6, and 12 months)
- Social cognitive factors: Self-regulation(Baseline, 3, 6, and 12 months)
- Social cognitive factors: Perceived social support(Baseline, 3, 6, and 12 months)
- CV risk factors: hyperlipidemia(Baseline, 3, 6, 12, and 18 months)
- CV risk factors: hypertension(Baseline, 3, 6, 12, and 18 months)
- CV risk factors: diabetes(Baseline, 3, 6, 12, and 18 months)
- CV risk factors: obesity(Baseline, 3, 6, 12, and 18 months)