Trial Outcomes & Findings for Researching Emotions And Cardiac Health (REACH): Phase II (NCT NCT02938052)

NCT ID: NCT02938052

Last Updated: 2021-09-01

Results Overview

Feasibility will be measured by examining the number of completed exercises.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2021-09-01

Participant Flow

Participant milestones

Measure	PP-Based Health Behavior Intervention Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One participant was terminated prior to the completion of baselines as they developed an acute medical illness unrelated to the study.

Baseline characteristics by cohort

Measure	Intervention Arm n=10 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=10 Participants
Age, Categorical >=65 years	8 Participants n=10 Participants
Sex: Female, Male Female	4 Participants n=10 Participants
Sex: Female, Male Male	6 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	1 Participants n=10 Participants
Race (NIH/OMB) White	9 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants
Positive and Negative Affect Schedule (PANAS)	38.70 units on a scale STANDARD_DEVIATION 3.53 • n=10 Participants • One participant was terminated prior to the completion of baselines as they developed an acute medical illness unrelated to the study.
Life Orientation Test-Revised (LOT-R)	20.90 units on a scale STANDARD_DEVIATION 2.42 • n=10 Participants • One participant was terminated prior to the completion of baselines as they developed an acute medical illness unrelated to the study.
Hospital Anxiety and Depression Scale (HADS) anxiety subscale	4.20 units on a scale STANDARD_DEVIATION 2.20 • n=10 Participants • One participant was terminated prior to the completion of baselines as they developed an acute medical illness unrelated to the study.
Hospital Anxiety and Depression Scale (HADS) depression subscale	1.40 units on a scale STANDARD_DEVIATION 1.26 • n=10 Participants • One participant was terminated prior to the completion of baselines as they developed an acute medical illness unrelated to the study.
Kansas City Cardiomyopathy Questionnaire (KCCQ) HRQoL score	85.83 units on a scale STANDARD_DEVIATION 11.82 • n=10 Participants • One participant was terminated prior to the completion of baselines as they developed an acute medical illness unrelated to the study.
Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom score	84.06 units on a scale STANDARD_DEVIATION 15.43 • n=10 Participants • One participant was terminated prior to the completion of baselines as they developed an acute medical illness unrelated to the study.
Medical Outcomes Study Short Form-12 (SF-12) Physical Health Composite Score	49.15 units on a scale STANDARD_DEVIATION 8.05 • n=10 Participants • One participant was terminated prior to the completion of baselines as they developed an acute medical illness unrelated to the study.
Medical Outcomes Study Short Form-12 (SF-12) Mental Health Composite Score	53.57 units on a scale STANDARD_DEVIATION 6.25 • n=10 Participants • One participant was terminated prior to the completion of baselines as they developed an acute medical illness unrelated to the study.
Medical Outcomes Study Specific Adherence Scale (MOS SAS)	12.70 units on a scale STANDARD_DEVIATION 1.34 • n=10 Participants • One participant was terminated prior to the completion of baselines as they developed an acute medical illness unrelated to the study.
Scored Sodium Questionnaire (SSQ)	56.70 units on a scale STANDARD_DEVIATION 22.38 • n=10 Participants • One participant was terminated prior to the completion of baselines as they developed an acute medical illness unrelated to the study.
Self-Reported Medication Adherence (SRMA)	96.00 percentage STANDARD_DEVIATION 5.16 • n=10 Participants • One participant was terminated prior to the completion of baselines as they developed an acute medical illness unrelated to the study.
Moderate to Vigorous Physical Activity (measured via Actigraph)	28.89 minutes/day STANDARD_DEVIATION 45.29 • n=9 Participants • 2 participants did not wear the Actigraph and provide adequate data at baseline.
Feasibility of Actigraph	9 Participants n=10 Participants
Physical Activity	6435 steps/day STANDARD_DEVIATION 6649 • n=9 Participants • Not all participants wore an Actigraph and provided adequate data at baseline.

PRIMARY outcome

Timeframe: 10 weeks

Feasibility will be measured by examining the number of completed exercises.

Outcome measures

Measure

Intervention Arm n=10 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.

Feasibility of the PP-based Health Behavior Intervention

7.8 Exercises Completed Standard Deviation 2.7

SECONDARY outcome

Timeframe: Change in score from Baseline to 10 weeks

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). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher scores indicate higher levels of positive affect.

Outcome measures

Measure

Intervention Arm n=9 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.

Changes in PANAS Scores

2.44 units on a scale Standard Deviation 3.54

SECONDARY outcome

Timeframe: Change of score from Baseline to 10 weeks

Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher scores indicate higher levels of optimism.

Outcome measures

Measure

Intervention Arm n=9 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.

Changes in LOT-R Scores

1.56 units on a scale Standard Deviation 1.94

SECONDARY outcome

Timeframe: Change in score from Baseline to 10 weeks

The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale was 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). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher scores indicate higher levels of anxiety.

Outcome measures

Measure

Intervention Arm n=9 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.

Changes in HADS-Anxiety Subscale Scores

2.0 units on a scale Standard Deviation 2.18

SECONDARY outcome

Timeframe: Change in score from Baseline to 10 weeks

The Hospital Anxiety and Depression Scale (HADS)-depression subscale was 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: 0-21). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher scores indicate worse outcome (i.e. greater levels of depression).

Outcome measures

Measure

Intervention Arm n=9 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.

Change in HADS-Depression Subscale Scores

.11 units on a scale Standard Deviation 1.17

SECONDARY outcome

Timeframe: Change in score from Baseline to 10 weeks

The Kansas City Cardiomyopathy Questionnaire is a well-validated questionnaire of health status in HF. The full scale will be used to measure HF-specific health-related QoL (HRQoL), and an eight-question subset of the KCCQ will be used as a measure of HF symptoms (QoL score range: 0-100; total symptom score range: 0-100). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher QoL scores indicate better HF specific health-related QoL, and higher total symptom scores indicate fewer symptoms.

Outcome measures

Measure	Intervention Arm n=9 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.
Changes in KCCQ Scores HRQoL score	5.56 units on a scale Standard Deviation 10.21
Changes in KCCQ Scores Total Symptom score	6.60 units on a scale Standard Deviation 10.44

SECONDARY outcome

Timeframe: Change in score from Baseline to 10 weeks

The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher scores indicate higher level of health related QoL.

Outcome measures

Measure	Intervention Arm n=9 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.
Changes in SF-12 Scores Physical Health Composite Score	2.44 units on a scale Standard Deviation 7.38
Changes in SF-12 Scores Metal Health Composite Score	2.17 units on a scale Standard Deviation 6.65

SECONDARY outcome

Timeframe: Change in score from Baseline to 10 weeks

Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score (Range: 3-18). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher scores indicate better adherence to health behaviors.

Outcome measures

Measure

Intervention Arm n=9 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.

Changes in MOS SAS Scores

2.78 units on a scale Standard Deviation 2.33

SECONDARY outcome

Timeframe: Change in score from Baseline to 10 weeks

The Scored Sodium Questionnaire (SSQ) is a self-report scale that assesses the frequency with which participants consume a variety of sodium-containing foods, ranging from "Rarely or Never Eaten" to "At Least Once Daily." It is used to calculate daily sodium intake (Range: 0-215). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher scores indicate higher sodium intake.

Outcome measures

Measure

Intervention Arm n=8 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.

Changes in Daily Sodium Intake (as Measured With the SSQ)

16.31 units on a scale Standard Deviation 18.92

SECONDARY outcome

Timeframe: Change in score from Baseline to 10 weeks

The Self-Reported Medication Adherence (SRMA) asks what percent of the time (in 10% increments) participants took all of their medications as prescribed in the past week and in the past 2 weeks (Range: 0-10). Change was calculated by subtracting the score at baseline from the score at 10 weeks.

Outcome measures

Measure

Intervention Arm n=9 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.

Self-Reported Medication Adherence (SRMA)

.44 percentage of time Standard Deviation .53

SECONDARY outcome

Timeframe: Baseline and 10 weeks

Population: Not all participants wore the Actigraph and provided adequate data.

Measured by Actigraph accelerometer, in number of steps per day.

Outcome measures

Measure

Intervention Arm n=8 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.

Change in Physical Activity

706 steps/day Standard Deviation 1616

SECONDARY outcome

Timeframe: Change in MVPA from Baseline to 10 weeks

ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline and again for one week at 10 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity. Change was calculated by subtracting the MVPA at baseline from the MVPA at 10 weeks.

Outcome measures

Measure

Intervention Arm n=8 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.

Change in Moderate to Vigorous Physical Activity (Actigraph)

.15 minutes/day Standard Deviation 9.97

SECONDARY outcome

Timeframe: Baseline and 10 weeks

Feasibility will be measured by examining the number of participants who use of the Actigraph.

Outcome measures

Measure	Intervention Arm n=10 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.
Feasibility of Actigraph Baseline Actigraph	9 Participants
Feasibility of Actigraph 10 Week Actigraph	8 Participants

SECONDARY outcome

Timeframe: Weeks 1-10

Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0-10). Higher scores indicate greater utility of the exercise. Weekly utility ratings were averaged to provide an overall utility score of the exercises.

Outcome measures

Measure

Intervention Arm n=10 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.

Acceptability of the Exercises: Utility Score

7.8 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: Weeks 1-10

Participants will provide ratings of ease after each exercise, measured on a 10-point Likert scale (0-10). Higher scores indicate greater ease of the exercise. Weekly ease ratings were averaged to provide an overall easy score of the exercises.

Outcome measures

Measure

Intervention Arm n=10 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.

Acceptability of the Exercises: Ease Score

7.5 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Weeks 1-10

Participants will provide ratings of optimism before and after each exercise, measured on a 10-point Likert scale (0-10). Weekly pre- and post-exercise ratings of optimism were averaged to provide an overall pre- and post-exercise optimism score. Higher scores indicate higher levels of optimism.

Outcome measures

Measure	Intervention Arm n=10 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.
Immediate Impact of the Exercises: Optimism Rating Pre-Exercise Rating	8.2 units on a scale Standard Deviation 1.5
Immediate Impact of the Exercises: Optimism Rating Post-Exercise Rating	8.4 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Weeks 1-10

Participants will provide ratings of positive affect, before and after each exercise, measured on a 10-point Likert scale (0-10). Weekly pre- and post-exercise ratings of happiness were averaged to provide an overall pre- and post-exercise score. Higher scores indicate higher levels of positive affect.

Outcome measures

Measure	Intervention Arm n=10 Participants Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.
Immediate Impact of the Exercises: Positive Affect Rating Pre-Exercise Rating	7.8 units on a scale Standard Deviation 1.5
Immediate Impact of the Exercises: Positive Affect Rating Post-Exercise Rating	8.6 units on a scale Standard Deviation 1.1

Adverse Events

Intervention Arm

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention Arm n=10 participants at risk Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.
Injury, poisoning and procedural complications Unexpected Fall	10.0% 1/10 • Number of events 1 • 1 year and 8 months
Cardiac disorders Arrhythmia	10.0% 1/10 • Number of events 1 • 1 year and 8 months

Other adverse events

Measure

Intervention Arm n=10 participants at risk Participants will all undergo a 10-week PP-based health behavior intervention and adherence measurements (baseline and Week 10). The participants will receive an ActiGraph accelerometer. They will be asked to begin wearing the accelerometer after their initial visit. Participants will wear the ActiGraph for 7 days at baseline and again at 10 weeks. PP-based health behavior intervention: The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.

Injury, poisoning and procedural complications Small, unexpected fall

10.0% 1/10 • Number of events 1 • 1 year and 8 months

Additional Information

Dr. Christopher Celano

Massachusetts General Hospital

Phone: 617-726-6485

Email: ccelano@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place