Positive Emotions Following Acute Cardiac Events

Acute Coronary Syndrome Clinical Trial

— PEACE-V  

Official title:

A Novel Psychological-behavioral Intervention to Promote Physical Activity After Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05412862
• Other study ID #: 2021P003302
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: Jeff C Huffman, M.D.
• Phone: 617-724-2910
• Email: jhuffman[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Physical Inactivity
• Syndrome

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 12 and 48 weeks	MVPA will be measured via an accelerometer and recorded in mean minutes/day.	Measured for 7 days at baseline, 12 weeks, and 48 weeks
Other	Change in Sedentary time	Sedentary time 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
Other	Change in optimism (Life Orientation Test - Revised [LOT-R])	Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of dispositional optimism.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in depressive symptoms (Patient Health Questionnaire [PHQ-9])	The Patient Health Questionnaire-9 (PHQ-9) will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-27). Higher scores indicate higher levels of depression.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in anxiety (Hospital Anxiety and Depression Scale - anxiety subscale [HADS-A])	The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of anxiety.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in locus of control (Form C of the Multidimensional Health Locus of Control scale [MHLC Form C])	Locus of control will be measured using the 18-item Multidimensional Health Locus of Control scale [MHLC Form C]. Scores on this scale range from 6-36, with higher scores indicating greater internal health locus of control.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in perceived social support (Multidimensional Scale of Perceived Social Support [MSPSS])	The MSPSS is a 12-item scale designed to measure perceived social support from three sources: Family, Friends, and a Significant Other. Scores on this scale range from 0-84, with higher scores indicating greater perceived social support.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in exercise-related self-efficacy (Self-efficacy for Exercise Scale [SEE])	The Self-efficacy for Exercise Scale will be used to measure exercise self-efficacy. This is a 9-item scale used to assess an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 20+ minutes per session in the future. Scores on this scale range from 0-90, with higher scores indicating greater self-efficacy for exercise.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in physical function (PROMIS 20-item Physical Function Short Form [PF-20])	The PROMIS 20-item short form (PF-20) will be used to assess physical function. Scores on this scale range from 20-100, with higher scores indicating greater physical function.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in mental health-related quality of life(Medical Outcomes Study Short Form-12 [SF-12] mental component score)	The SF-12 mental component score will be used to assess mental health-related quality of life (Range: 0-100). Higher scores indicate higher levels of mental health-related quality of life.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in physical health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] physical component score)	The SF-12 physical component score will be used to assess physical health-related quality of life (Range: 0-100). Higher scores indicate higher levels of physical health-related quality of life.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in adherence to cardiac medications	Medication adherence will be measured with the self-report medication adherence tool from the NHLBI Heart and Soul Study.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	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])	Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in self-reported MVPA (International Physical Activity Questionnaire [IPAQ])	Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure assesses the types of intensity of physical activity that people do as part of their daily lives. Moderate and vigorous intensity activities will be converted to multiples of resting energy expenditure (MET) minutes per week.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in self-reported sedentary time (International Physical Activity Questionnaire [IPAQ])	Measured by the self-report International Physical Activity Questionnaire (IPAQ). Measured in hours per day.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Major adverse cardiac events (MACE)	MACE will be defined as mortality or hospitalization for heart failure or an acute coronary event (percutaneous coronary intervention or acute coronary syndrome). Data regarding hospitalizations and mortality will be obtained using a three-pronged approach consisting of systematic queries of participants, electronic health record review, and review of records from the National Death Index.	Through study completion, an average of 2.7 years
Other	All-cause hospitalizations	We will record all-cause hospitalizations for all participants from enrollment to the end of the study data collection period, using systematic queries of participants and review of electronic health records from all Mass General Brigham-affiliated hospitals.	Through study completion, an average of 2.7 years
Other	Attendance at cardiac rehabilitation	We will query participants at each follow-up time point to determine whether they have attended cardiac rehabilitation.	12 weeks, 24 weeks, 48 weeks
Other	Change in weight (kilograms)	Weight will be measured during study visits.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in body mass index (kilograms per square meter)	Height and weight will be measured during study visits.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in blood pressure (millimeters of mercury)	Blood pressure (diastolic and systolic) will be measured by trained nurses using a standardized protocol.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol (milligrams per deciliter)	Fasting blood samples will be obtained at study visits.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in triglycerides (milligrams per deciliter)	Fasting blood samples will be obtained at study visits.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in glucose (milligrams per deciliter)	Fasting blood samples will be obtained at study visits.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in interleukin-6 (picograms per milliliter)	Blood samples will be obtained at study visits.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in high sensitivity C-reactive protein (milligrams per liter)	Blood samples will be obtained at study visits.	Baseline, 12 weeks, 24 weeks, 48 weeks
Other	Change in endothelin-1 (picograms per milliliter)	Blood samples will be obtained at study visits.	Baseline, 12 weeks, 24 weeks, 48 weeks
Primary	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
Secondary	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
Secondary	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