Clinical trial NCT05412862: Positive Emotions Following Acute Cardiac Events
Official title: A Novel Psychological-behavioral Intervention to Promote Physical Activity After Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
Physical Inactivity
Keywords: Positive psychology
Physical Activity
Motivational Interviewing
Adherence
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-blinded, controlled trial
Primary purpose: TREATMENT

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 intervention's impact on psychological (e.g. positive affect), functional (e.g. physical function), and behavioral (e.g. overall adherence) outcomes.
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 24 weeks
timeFrame: Measured for 7 days at baseline and 24 weeks
Secondary outcomes:
measure: Change in Light Intensity Activity
timeFrame: Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks
measure: Change in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
Other outcomes:
measure: Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 12 and 48 weeks
timeFrame: Measured for 7 days at baseline, 12 weeks, and 48 weeks
measure: Change in Sedentary time
timeFrame: Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks
measure: Change in optimism (Life Orientation Test - Revised [LOT-R])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in depressive symptoms (Patient Health Questionnaire [PHQ-9])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in anxiety (Hospital Anxiety and Depression Scale - anxiety subscale [HADS-A])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in locus of control (Form C of the Multidimensional Health Locus of Control scale [MHLC Form C])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in perceived social support (Multidimensional Scale of Perceived Social Support [MSPSS])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in exercise-related self-efficacy (Self-efficacy for Exercise Scale [SEE])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in physical function (PROMIS 20-item Physical Function Short Form [PF-20])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in mental health-related quality of life(Medical Outcomes Study Short Form-12 [SF-12] mental component score)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in physical health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] physical component score)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in adherence to cardiac medications
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in Fat/saturated fat/cholesterol intake (Meat, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks [MEDFICTS])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in self-reported MVPA (International Physical Activity Questionnaire [IPAQ])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in self-reported sedentary time (International Physical Activity Questionnaire [IPAQ])
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Major adverse cardiac events (MACE)
timeFrame: Through study completion, an average of 2.7 years
measure: All-cause hospitalizations
timeFrame: Through study completion, an average of 2.7 years
measure: Attendance at cardiac rehabilitation
timeFrame: 12 weeks, 24 weeks, 48 weeks
measure: Change in weight (kilograms)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in body mass index (kilograms per square meter)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in blood pressure (millimeters of mercury)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol (milligrams per deciliter)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in triglycerides (milligrams per deciliter)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in glucose (milligrams per deciliter)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in interleukin-6 (picograms per milliliter)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in high sensitivity C-reactive protein (milligrams per liter)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
measure: Change in endothelin-1 (picograms per milliliter)
timeFrame: Baseline, 12 weeks, 24 weeks, 48 weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jeff C Huffman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: