Ignite Creation Date:
2024-05-06 @ 5:44 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05412862
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2022-05-25
Brief Title:
Positive Emotions Following Acute Cardiac Events
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Novel Psychological-behavioral Intervention to Promote Physical Activity After Acute Coronary Syndrome
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEACE-V
Brief Summary:
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
Detailed Description:
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
1 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
2 Assess the interventions impact on psychological eg positive affect functional eg physical function and behavioral eg overall adherence outcomes
3 Explore the interventions impact on markers of cardiovascular health eg cardiac biomarkers as well as major adverse cardiac eventsreadmissions
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 weeks session content and a discussion of the rationale and assignment of the next weeks exerciseassignment
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
In this project the investigators hope to do the following
1 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
2 Assess the interventions impact on psychological eg positive affect functional eg physical function and behavioral eg overall adherence outcomes
3 Explore the interventions impact on markers of cardiovascular health eg cardiac biomarkers as well as major adverse cardiac eventsreadmissions
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 weeks session content and a discussion of the rationale and assignment of the next weeks exerciseassignment
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None