治験レーダーAI | ||
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治験 NCT05412862 (PEACE-V)（対象：急性冠症候群、身体不活動）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
Positive Emotions Following Acute Cardiac Events (PEACE-V)
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.
Following the first in-person visit, participants in the treatment condition will complete twelve weekly phone sessions with a study trainer. The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment.
Participants in the treatment condition will receive twice weekly text messages throughout the intervention (Weeks 1-12) and initial follow-up period (Weeks 13-24). These messages will focus on the PP activity and physical activity. During Weeks 13-24, participants in the PP-MI condition will engage with twice weekly, automated, interactive text messages related to PP and physical activity.
At Weeks 12, 24, and 48, participants will complete follow-up visits. One week prior to these visits, participants will be mailed an accelerometer and will wear it until their study visit. During these study visits, participants will be asked to answer questionnaires related to psychological and physical health and functioning, have their blood pressure and weight measured, and be asked about cardiovascular outcomes, including hospitalizations, cardiovascular procedures, and cardiac-specific hospitalizations. They will also provide a fasting blood sample.
Finally, participants will complete phone sessions every 6 months until study end to inquire about hospitalizations and adverse cardiac events.
A Novel Psychological-behavioral Intervention to Promote Physical Activity After Acute Coronary Syndrome
- PEACE-V
- 2021P003302
Physical Activity
Motivational Interviewing
Adherence
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的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). | Positive Psychology + Motivational Interviewing The 12-week PP-MI intervention focuses on enhancing well-being (through PP) and increasing physical activity (through MI). Each week, participants will complete a PP activity and work towards a physical activity goal, then complete a phone session with a study trainer. The PP portion of the program will focus on the cultivation of well-being through the performance of easy-to complete activities (e.g., using a strength in a new way) and review of the positive feelings they generate. The MI portion of the program will focus on assisting participants to improve physical activity levels, resolve ambivalence to behavior change, set realistic physical activity goals, problem-solve barriers, and identify resources to complete behavior change. Finally, participants will receive twice weekly text messages (for 24 weeks) to encourage completion of PP activities and engagement in physical activity. |
非介入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. | 該当なし |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 24 weeks | MVPA will be measured via an accelerometer and recorded in mean minutes/day. | Measured for 7 days at baseline and 24 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in Light Intensity Activity | Light intensity activity will be measured via an accelerometer and recorded in mean minutes/day. | 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) | The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect. | Baseline, 12 weeks, 24 weeks, 48 weeks |
- 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)
- 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
Massachusetts General HospitalMassachusetts