REACH II: Researching Emotions And Cardiac Health (REACH): Phase II

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02938052
• Collaborator: National Institutes of Health (NIH) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.1
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The focus of this study is to examine the feasibility, acceptability, and preliminary impact of our customized positive psychology (PP)-based health behavior intervention in a group of patients with mild to moderate heart failure (HF).

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure; Emotions; Patient Compliance	Behavioral: PP-based health behavior intervention	N/A

Detailed Description

The investigators are proposing a study that will specifically and innovatively focus on the development of a novel positive psychology intervention that is adapted for patients with HF. The MGH inpatient units and MGH Heart Center outpatients will serve as the source of subjects for the study, with patients who have a diagnosis of HF serving as potential subjects. The investigators will enroll 10 HF patients, who will take part in an 10-week PP-based health behavior intervention.

In this project, the investigators hope to do the following:

1. Test an 10-week, telephone-delivered health behavior intervention utilizing PP exercises and systematic goal-setting in a brief, non-randomized, proof-of-concept trial (N=10).

2. Determine whether this initial intervention is feasible in a small cohort of HF patients.

3. Explore potential benefits of the intervention on outcomes of interest (e.g., optimism, positive affect).

Baseline information about enrolled participants will be obtained from the patients, care providers, and the electronic medical record as required for characterization of our population. This information will include data regarding medical history (history of prior acute coronary syndrome, coronary artery bypass graft, congestive HF, hypertension, diabetes mellitus, hyperlipidemia, and current smoking), current medical variables (renal function, left ventricular ejection fraction, NYHA class), medications, and sociodemographic data (age, gender, race/ethnicity, living alone).

Participants will under go an initial visit during which they will meet with study staff in person (or if preferred over the phone).

• They will fill out baseline questionnaires, and be provided a treatment manual with weekly exercises, along with a copy of Learning to Live with Heart Failure. The PP and goal-setting portions of the intervention will be introduced, and the first exercise will be assigned. Finally, participants will be provided an ActiGraph accelerometer to wear for 7 days, as well as a personal step counter to keep.

Participants will undergo weekly phone sessions for 10 weeks.

• For the positive psychology segment the participant will review the previous week's exercise, discuss of the rationale of the next week's exercise, and be assigned the next week's exercise.

• For the goal-setting segment the participant will review the health goal from the prior week, receive education about a health behavior, discuss ways to improve health behaviors, and set a goal for the next week.

Participants will undergo a follow-up phone call at 10 weeks that asks the same questions that were answered during the initial visit, as well as questions about their experience using the ActiGraph.

• At Week 10, participants will wear another ActiGraph for 7 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Developing a Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: proof-of Concept Trial
• Actual Study Start Date: Dec 6, 2016
• Actual Primary Completion Date: Jul 24, 2017
• Actual Study Completion Date: Aug 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Feasibility of the PP-based Health Behavior Intervention [10 weeks]

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

Secondary Outcome Measures

1. Changes in PANAS Scores [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.

2. Changes in LOT-R Scores [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.

3. Changes in HADS-Anxiety Subscale Scores [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.

4. Change in HADS-Depression Subscale Scores [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).

5. Changes in KCCQ Scores [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.

6. Changes in SF-12 Scores [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.

7. Changes in MOS SAS Scores [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.

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

9. Self-Reported Medication Adherence (SRMA) [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.

10. Change in Physical Activity [Baseline and 10 weeks]

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

11. Change in Moderate to Vigorous Physical Activity (Actigraph) [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.

12. Feasibility of Actigraph [Baseline and 10 weeks]

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

13. Acceptability of the Exercises: Utility Score [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.

14. Acceptability of the Exercises: Ease Score [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.

15. Immediate Impact of the Exercises: Optimism Rating [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.

16. Immediate Impact of the Exercises: Positive Affect Rating [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult patients with NYHA class I, II, or III HF admitted to an MGH inpatient unit or outpatients at the MGH Heart Center. Patients with NYHA class IV HF have ongoing HF symptoms at rest, making it difficult for them to increase physical activity and other health behaviors; therefore, they will not be included. HF diagnosis will be confirmed via chart review and with the patient's treatment team as needed.

• Suboptimal adherence to health behaviors. This will be defined as a total score of ≤15 on three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items regarding diet/exercise/medications. The MOS SAS has been used in multiple prior studies assessing adherence in cardiac patients, including our own studies in this population. This threshold score on the MOS SAS will ensure that all participants will have the potential to improve their health behaviors.

Exclusion Criteria:

• Cognitive deficits impeding a participant's ability to provide informed consent or participate, assessed via a 6-item cognitive test that is sensitive and specific for screening for cognitive impairment in research participants.

• Medical conditions precluding interviews or likely to lead to death within 6 months.

• Inability to speak English, inability to read or write, inability to walk, or lack of a telephone.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• National Institutes of Health (NIH)
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Christopher M Celano, MD, Massachusetts General Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 28, 2017

More Information

Publications

None provided.

• Responsible Party: Christopher Celano, Assistant in Psychiatry, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02938052
• Other Study ID Numbers: 2016P001443; 1K23HL123607-01A1
• First Posted: Oct 19, 2016
• Last Update Posted: Sep 1, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Christopher Celano, Assistant in Psychiatry, Massachusetts General Hospital: Heart Failure; Positive Psychology; Adherence to Health Behaviors
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Arm/Group Title	PP-Based Health Behavior Intervention
Arm/Group Description	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.
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Intervention Arm
Arm/Group Description	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 Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 20%
>=65 years	8 80%
Sex: Female, Male (Count of Participants)
Female	4 40%
Male	6 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	10 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 10%
White	9 90%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%
Positive and Negative Affect Schedule (PANAS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	38.70 (3.53)
Life Orientation Test-Revised (LOT-R) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	20.90 (2.42)
Hospital Anxiety and Depression Scale (HADS) anxiety subscale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.20 (2.20)
Hospital Anxiety and Depression Scale (HADS) depression subscale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.40 (1.26)
Kansas City Cardiomyopathy Questionnaire (KCCQ) (units on a scale) [Mean (Standard Deviation) ]
HRQoL score	85.83 (11.82)
Total Symptom score	84.06 (15.43)
Medical Outcomes Study Short Form-12 (SF-12) (units on a scale) [Mean (Standard Deviation) ]
Physical Health Composite Score	49.15 (8.05)
Mental Health Composite Score	53.57 (6.25)
Medical Outcomes Study Specific Adherence Scale (MOS SAS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	12.70 (1.34)
Scored Sodium Questionnaire (SSQ) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	56.70 (22.38)
Self-Reported Medication Adherence (SRMA) (percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage]	96.00 (5.16)
Moderate to Vigorous Physical Activity (measured via Actigraph) (minutes/day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes/day]	28.89 (45.29)
Feasibility of Actigraph (Count of Participants)
Count of Participants [Participants]	9 90%
Physical Activity (steps/day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [steps/day]	6435 (6649)

Outcome Measures

1. Primary Outcome

Title	Feasibility of the PP-based Health Behavior Intervention
Description	Feasibility will be measured by examining the number of completed exercises.
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Deviation) [Exercises Completed]	7.8 (2.7)

2. Secondary Outcome

Title	Changes in PANAS Scores
Description	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.
Time Frame	Change in score from Baseline to 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP-Based Health Behavior Intervention
Arm/Group Description	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.
Measure Participants	9
Mean (Standard Deviation) [units on a scale]	2.44 (3.54)

3. Secondary Outcome

Title	Changes in LOT-R Scores
Description	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.
Time Frame	Change of score from Baseline to 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP-Based Health Behavior Intervention
Arm/Group Description	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.
Measure Participants	9
Mean (Standard Deviation) [units on a scale]	1.56 (1.94)

4. Secondary Outcome

Title	Changes in HADS-Anxiety Subscale Scores
Description	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.
Time Frame	Change in score from Baseline to 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP-Based Health Behavior Intervention
Arm/Group Description	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.
Measure Participants	9
Mean (Standard Deviation) [units on a scale]	2.0 (2.18)

5. Secondary Outcome

Title	Change in HADS-Depression Subscale Scores
Description	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).
Time Frame	Change in score from Baseline to 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP-Based Health Behavior Intervention
Arm/Group Description	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.
Measure Participants	9
Mean (Standard Deviation) [units on a scale]	.11 (1.17)

6. Secondary Outcome

Title	Changes in KCCQ Scores
Description	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.
Time Frame	Change in score from Baseline to 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP-Based Health Behavior Intervention
Arm/Group Description	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.
Measure Participants	9
HRQoL score	5.56 (10.21)
Total Symptom score	6.60 (10.44)

7. Secondary Outcome

Title	Changes in SF-12 Scores
Description	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.
Time Frame	Change in score from Baseline to 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP-Based Health Behavior Intervention
Arm/Group Description	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.
Measure Participants	9
Physical Health Composite Score	2.44 (7.38)
Metal Health Composite Score	2.17 (6.65)

8. Secondary Outcome

Title	Changes in MOS SAS Scores
Description	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.
Time Frame	Change in score from Baseline to 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP-Based Health Behavior Intervention
Arm/Group Description	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.
Measure Participants	9
Mean (Standard Deviation) [units on a scale]	2.78 (2.33)

9. Secondary Outcome

Title	Changes in Daily Sodium Intake (as Measured With the SSQ)
Description	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.
Time Frame	Change in score from Baseline to 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP-Based Health Behavior Intervention
Arm/Group Description	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.
Measure Participants	8
Mean (Standard Deviation) [units on a scale]	16.31 (18.92)

10. Secondary Outcome

Title	Self-Reported Medication Adherence (SRMA)
Description	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.
Time Frame	Change in score from Baseline to 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP-Based Health Behavior Intervention
Arm/Group Description	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.
Measure Participants	9
Mean (Standard Deviation) [percentage of time]	.44 (.53)

11. Secondary Outcome

Title	Change in Physical Activity
Description	Measured by Actigraph accelerometer, in number of steps per day.
Time Frame	Baseline and 10 weeks

Outcome Measure Data

Analysis Population Description

Not all participants wore the Actigraph and provided adequate data.

Arm/Group Title	PP-Based Health Behavior Intervention
Arm/Group Description	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.
Measure Participants	8
Mean (Standard Deviation) [steps/day]	706 (1616)

12. Secondary Outcome

Title	Change in Moderate to Vigorous Physical Activity (Actigraph)
Description	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.
Time Frame	Change in MVPA from Baseline to 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP-Based Health Behavior Intervention
Arm/Group Description	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.
Measure Participants	8
Mean (Standard Deviation) [minutes/day]	.15 (9.97)

13. Secondary Outcome

Title	Feasibility of Actigraph
Description	Feasibility will be measured by examining the number of participants who use of the Actigraph.
Time Frame	Baseline and 10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP-Based Health Behavior Intervention
Arm/Group Description	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.
Measure Participants	10
Baseline Actigraph	9 90%
10 Week Actigraph	8 80%

14. Secondary Outcome

Title	Acceptability of the Exercises: Utility Score
Description	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.
Time Frame	Weeks 1-10

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Deviation) [units on a scale]	7.8 (1.8)

15. Secondary Outcome

Title	Acceptability of the Exercises: Ease Score
Description	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.
Time Frame	Weeks 1-10

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Deviation) [units on a scale]	7.5 (2.1)

16. Secondary Outcome

Title	Immediate Impact of the Exercises: Optimism Rating
Description	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.
Time Frame	Weeks 1-10

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP-Based Health Behavior Intervention
Arm/Group Description	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.
Measure Participants	10
Pre-Exercise Rating	8.2 (1.5)
Post-Exercise Rating	8.4 (1.3)

17. Secondary Outcome

Title	Immediate Impact of the Exercises: Positive Affect Rating
Description	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.
Time Frame	Weeks 1-10

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP-Based Health Behavior Intervention
Arm/Group Description	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.
Measure Participants	10
Pre-Exercise Rating	7.8 (1.5)
Post-Exercise Rating	8.6 (1.1)

Adverse Events

Time Frame	1 year and 8 months
Arm/Group Title	Intervention Arm
Arm/Group Description	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.
All Cause Mortality
	Intervention Arm
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Intervention Arm
	Affected / at Risk (%)	# Events
Total	2/10 (20%)
Cardiac disorders
Arrhythmia	1/10 (10%)	1
Injury, poisoning and procedural complications
Unexpected Fall	1/10 (10%)	1
Other (Not Including Serious) Adverse Events
	Intervention Arm
	Affected / at Risk (%)	# Events
Total	1/10 (10%)
Injury, poisoning and procedural complications
Small, unexpected fall	1/10 (10%)	1

Limitations/Caveats

Was performed at a single academic medical center and had a largely White population. It was a small sample size and there was no control condition in this initial trial.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.