Congestive Heart Failure, Emotions, Patient Compliance
Conditions
Keywords
Heart Failure, Positive Psychology, Adherence to Health Behaviors
Brief summary
The focus of this study is to examine the feasibility, acceptability, and preliminary impact of a 12-week, telephone-delivered, positive psychology (PP)-based health behavior intervention in a group of patients with mild to moderate heart failure (HF), compared to a motivational interviewing- (MI-) based education condition and treatment as usual (TAU).
Detailed description
The investigators are proposing a study that will focus on the implementation of a novel PP-based health behavior intervention that is adapted for patients with HF. The MGH inpatient units, MGH Heart Center, and MGH primary care clinic outpatients will serve as the source of participants for the study, with patients who have a diagnosis of HF serving as potential participants. The investigators will enroll 60 HF patients, who will take part in a 12-week PP-based health behavior intervention. In this project, the investigators hope to do the following: 1. Test a 12-week, telephone-delivered health behavior intervention utilizing PP exercises and systematic goal-setting in a three-arm, randomized, controlled pilot trial in patients with mild to moderate HF (N=60). 2. Determine whether this optimized intervention is feasible in a small cohort of HF patients. 3. Explore potential benefits of the intervention on outcomes of interest (e.g., psychological health, functioning, and health behavior adherence) compared to a motivational interviewing- (MI) based education condition and treatment as usual (TAU). 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 disease, 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 undergo two in person visits during which they will meet with study staff in person (or if preferred over the phone). In their first visit, they will answer questionnaires related to psychological and physical health and functioning and will be asked to wear an accelerometer for one week to measure their baseline physical activity. At their second in-person visit, they will be randomized to receive (1) the PP-based health behavior intervention, (2) the MI-based educational condition, or (3) TAU. Participants in the TAU group will not receive any additional intervention but will complete follow-up phone calls at 12 and 24 weeks. Following randomization, participants in the two treatment groups will be provided a treatment manual corresponding with their treatment condition with weekly exercises, along with a copy of the Learning to Live with Heart Failure guide. The appropriate intervention will be introduced, and the first exercise will be assigned. Finally, participants in both treatment groups will receive a personal step counter to use over the course of the study. Following the second in-person visit, participants in the PP-based intervention and MI-based control condition groups will complete twelve 30- to 45-minute 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. At Weeks 12 and 24, a member of the study staff will call participants to repeat the self-report questionnaires that were administered at baseline. At these two time points, participants also will be asked to wear an accelerometer for an additional 7 days to measure physical activity.
Interventions
BEHAVIORALPP-based health behavior intervention
The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.
BEHAVIORALMI-based educational control condition
The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.
Sponsors
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and treating study staff will be aware of the participant's treatment condition. However, follow-up assessments will be performed by a study staff member that is masked to the participant's treatment condition.
Intervention model description
Randomized, single-blinded, controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 or MGH-affiliated primary care clinic. 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) items regarding diet/exercise/medications. The MOS 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the PP-based Health Behavior Intervention | Change between baseline and 12 weeks | Feasibility will be measured by examining the number of completed exercises for individuals randomized to the Positive Psychology (PP)-based intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate Impact of the Exercises | Weekly, up to 12 weeks | Participants receiving the PP-based health behavior intervention will provide ratings of optimism and positive affect, before and after each exercise, measured on a 10-point Likert scale. |
| Change in PANAS Scores (Primary Psychological Outcome) | Baseline, 12 weeks, and 24 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 12 and 24 weeks. Higher scores indicate higher levels of positive affect. |
| Changes in LOT-R Scores | Baseline, 12 weeks, and 24 weeks | Life Orientation Test-Revised (LOT-R) 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 12 and 24 weeks. Higher scores indicate higher levels of dispositional optimism. |
| Changes in SOM Scores | Baseline, 12 weeks, and 24 weeks | The State Optimism Measure (SOM) will be used to measure state optimism (Range: 7-35). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of state optimism. |
| Changes in HADS-Anxiety Subscale Scores | Baseline, 12 weeks, and 24 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 12 weeks and 24 weeks. Higher scores indicate higher levels of anxiety. |
| Change in HADS-Depression Subscale Scores | Baseline, 12 weeks, and 24 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 12 weeks and 24 weeks. Higher scores indicate higher levels of depression. |
| Changes in KCCQ Scores (Primary Functional Outcome) | Baseline, 12 weeks, and 24 weeks | The Kansas City Cardiomyopathy Questionnaire (KCCQ) 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 12 weeks and 24 weeks. Higher QoL scores indicate better HF specific health-related QoL, and higher total symptom scores indicate fewer symptoms. |
| Acceptability of the Exercises | 12 weeks | Participants receiving the PP-based health behavior intervention will provide ratings of ease and utility after each exercise, measured on a 10-point Likert scale. |
| Changes in MOS SAS Scores | Baseline, 12 weeks, and 24 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 12 weeks and 24 weeks. Higher scores indicate better adherence to health behaviors. |
| Changes in Sodium Intake (as Measured With the SSQ) | Baseline, 12 weeks, and 24 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 12 weeks and 24 weeks. Higher scores indicate higher sodium intake. |
| Changes in Self-Reported Medication Adherence (SRMA) | Baseline, 12 weeks and 24 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: 0-100). Change was calculated by subtracting the score at baseline from the score at 10 weeks. |
| Change in Physical Activity | Baseline, 12 weeks, and 24 weeks | Assessed by ActiGraph GT3X+ step counters which are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. We will measure both number of steps per day (primary physical health outcome). Change scores will be calculated by subtracting the number of steps per day at baseline from number of steps per day at 12 weeks and 24 weeks. |
| Change in Moderate to Vigorous Physical Activity | Baseline, 12 weeks, and 24 weeks | Assessed with ActiGraph GT3X+ step counters, which are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. Change was calculated by subtracting the MVPA at baseline from the MVPA at 12 weeks and 24 weeks. |
| Feasibility of Actigraph | Baseline, 12 weeks and 24 weeks | Feasibility will be measured by examining the number of participants who provide adequate Actigraph data, defined in this study as at least 480 minutes for 5 days, at each time point. |
| Changes in SF-12 Scores | Baseline, 12 weeks, and 24 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 12 weeks and 24 weeks. Higher scores indicate higher level of health related QoL. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PP-based Health Behavior Intervention Participants will undergo a 12-week, Positive Psychology (PP)-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.
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 portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence. | 15 |
| MI-based Educational Control Condition Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.
Motivational Interviewing (MI)-based educational control condition: The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management. | 15 |
| Treatment as Usual (TAU) Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits. | 15 |
| Total | 45 |
Baseline characteristics
| Characteristic | PP-based Health Behavior Intervention | MI-based Educational Control Condition | Treatment as Usual (TAU) | Total |
|---|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 8.5 | 74.6 years STANDARD_DEVIATION 10.4 | 71.8 years STANDARD_DEVIATION 10.6 | 70.8 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 15 Participants | 15 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Feasibility of Actigraph | 15 Participants | 15 Participants | 15 Participants | 45 Participants |
| Hospital Anxiety and Depression Scale (HADS) anxiety subscale | 6.47 units on a scale STANDARD_DEVIATION 3.72 | 6.33 units on a scale STANDARD_DEVIATION 4.01 | 5.60 units on a scale STANDARD_DEVIATION 4.56 | 6.13 units on a scale STANDARD_DEVIATION 4.04 |
| Hospital Anxiety and Depression Scale (HADS) depression subscale | 5.07 units on a scale STANDARD_DEVIATION 3.35 | 5.40 units on a scale STANDARD_DEVIATION 3.92 | 5.13 units on a scale STANDARD_DEVIATION 4.02 | 5.20 units on a scale STANDARD_DEVIATION 3.69 |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | 75.36 units on a scale STANDARD_DEVIATION 19.16 | 68.91 units on a scale STANDARD_DEVIATION 24.35 | 78.15 units on a scale STANDARD_DEVIATION 14.99 | 74.14 units on a scale STANDARD_DEVIATION 19.81 |
| Life Orientation Test-Revised (LOT-R) | 17.33 units on a scale STANDARD_DEVIATION 3.64 | 18.13 units on a scale STANDARD_DEVIATION 4.55 | 15.73 units on a scale STANDARD_DEVIATION 4.77 | 17.07 units on a scale STANDARD_DEVIATION 4.37 |
| Medical Outcomes Study Short Form-12 (SF-12) Mental Health Composite Score | 42.21 units on a scale STANDARD_DEVIATION 11.2 | 50.26 units on a scale STANDARD_DEVIATION 8.72 | 48.22 units on a scale STANDARD_DEVIATION 9.99 | 46.90 units on a scale STANDARD_DEVIATION 10.38 |
| Medical Outcomes Study Short Form-12 (SF-12) Physical Health Composite Score | 42.13 units on a scale STANDARD_DEVIATION 10.05 | 37.94 units on a scale STANDARD_DEVIATION 13.68 | 40.14 units on a scale STANDARD_DEVIATION 10.4 | 40.07 units on a scale STANDARD_DEVIATION 11.36 |
| Medical Outcomes Study Specific Adherence Scale (MOS SAS) | 11.87 units on a scale STANDARD_DEVIATION 2.33 | 12.60 units on a scale STANDARD_DEVIATION 2.1 | 12.73 units on a scale STANDARD_DEVIATION 1.28 | 12.40 units on a scale STANDARD_DEVIATION 1.95 |
| Moderate to Vigorous Physical Activity | 7.5 minutes/day STANDARD_DEVIATION 6.8 | 5.9 minutes/day STANDARD_DEVIATION 6.9 | 15.2 minutes/day STANDARD_DEVIATION 19.8 | 9.5 minutes/day STANDARD_DEVIATION 13.1 |
| Physical Activity | 3465 steps/day STANDARD_DEVIATION 1484 | 3458 steps/day STANDARD_DEVIATION 1616 | 4195 steps/day STANDARD_DEVIATION 2375 | 3706 steps/day STANDARD_DEVIATION 1857 |
| Positive and Negative Affect Schedule (PANAS) | 31.53 units on a scale STANDARD_DEVIATION 7.95 | 33.93 units on a scale STANDARD_DEVIATION 7.21 | 32.33 units on a scale STANDARD_DEVIATION 5.81 | 32.60 units on a scale STANDARD_DEVIATION 6.96 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 12 Participants | 14 Participants | 39 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 15 participants | 45 participants |
| Scored Sodium Questionnaire (SSQ) | 71.10 units on a scale STANDARD_DEVIATION 29.09 | 64.90 units on a scale STANDARD_DEVIATION 27.79 | 64.37 units on a scale STANDARD_DEVIATION 21.15 | 66.79 units on a scale STANDARD_DEVIATION 25.82 |
| Self-Reported Medication Adherence (SRMA) | 95.33 percentage STANDARD_DEVIATION 5.16 | 96.67 percentage STANDARD_DEVIATION 4.88 | 96.67 percentage STANDARD_DEVIATION 6.17 | 96.22 percentage STANDARD_DEVIATION 5.35 |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 11 Participants | 33 Participants |
| State Optimism Measure (SOM) | 26.33 units on a scale STANDARD_DEVIATION 4.85 | 26.93 units on a scale STANDARD_DEVIATION 5.54 | 27.67 units on a scale STANDARD_DEVIATION 4.51 | 26.98 units on a scale STANDARD_DEVIATION 4.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 3 / 15 | 5 / 15 | 1 / 15 |
| serious Total, serious adverse events | 1 / 15 | 1 / 15 | 1 / 15 |
Outcome results
Primary
Feasibility of the PP-based Health Behavior Intervention
Feasibility will be measured by examining the number of completed exercises for individuals randomized to the Positive Psychology (PP)-based intervention.
Time frame: Change between baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PP-based Health Behavior Intervention | Feasibility of the PP-based Health Behavior Intervention | 8.7 sessions completed out of 12 sessions | Standard Deviation 4.9 |
Secondary
Acceptability of the Exercises
Participants receiving the PP-based health behavior intervention will provide ratings of ease and utility after each exercise, measured on a 10-point Likert scale.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PP-based Health Behavior Intervention | Acceptability of the Exercises | Ease | 7.5 rating out of 10 | Standard Deviation 1.7 |
| PP-based Health Behavior Intervention | Acceptability of the Exercises | Utility | 7.5 rating out of 10 | Standard Deviation 1.6 |
Secondary
Change in HADS-Depression Subscale Scores
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 12 weeks and 24 weeks. Higher scores indicate higher levels of depression.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: Not all participants provided follow-up data at both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PP-based Health Behavior Intervention | Change in HADS-Depression Subscale Scores | 12 weeks | -1.57 units on a scale | Standard Deviation 2.47 |
| PP-based Health Behavior Intervention | Change in HADS-Depression Subscale Scores | 24 weeks | -1.57 units on a scale | Standard Deviation 2.24 |
| MI-based Educational Control Condition | Change in HADS-Depression Subscale Scores | 12 weeks | -0.93 units on a scale | Standard Deviation 2.53 |
| MI-based Educational Control Condition | Change in HADS-Depression Subscale Scores | 24 weeks | -0.38 units on a scale | Standard Deviation 5.12 |
| Treatment as Usual (TAU) | Change in HADS-Depression Subscale Scores | 12 weeks | -1.00 units on a scale | Standard Deviation 2.63 |
| Treatment as Usual (TAU) | Change in HADS-Depression Subscale Scores | 24 weeks | -1.00 units on a scale | Standard Deviation 3.33 |
Secondary
Change in Moderate to Vigorous Physical Activity
Assessed with ActiGraph GT3X+ step counters, which are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. Change was calculated by subtracting the MVPA at baseline from the MVPA at 12 weeks and 24 weeks.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: Not all participants provided wore Actigraph GT3X+ step counters or provided follow-up data at both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PP-based Health Behavior Intervention | Change in Moderate to Vigorous Physical Activity | 12 weeks | 5.72 minutes/day | Standard Deviation 10.58 |
| PP-based Health Behavior Intervention | Change in Moderate to Vigorous Physical Activity | 24 weeks | 5.18 minutes/day | Standard Deviation 15.02 |
| MI-based Educational Control Condition | Change in Moderate to Vigorous Physical Activity | 12 weeks | 0.27 minutes/day | Standard Deviation 2.85 |
| MI-based Educational Control Condition | Change in Moderate to Vigorous Physical Activity | 24 weeks | -2.66 minutes/day | Standard Deviation 4.48 |
| Treatment as Usual (TAU) | Change in Moderate to Vigorous Physical Activity | 12 weeks | -4.11 minutes/day | Standard Deviation 19.02 |
| Treatment as Usual (TAU) | Change in Moderate to Vigorous Physical Activity | 24 weeks | -1.32 minutes/day | Standard Deviation 6.23 |
Secondary
Change in PANAS Scores (Primary Psychological Outcome)
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 12 and 24 weeks. Higher scores indicate higher levels of positive affect.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: Not all participants provided follow-up data at both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PP-based Health Behavior Intervention | Change in PANAS Scores (Primary Psychological Outcome) | 12 weeks | 5.38 units on a scale | Standard Deviation 7.84 |
| PP-based Health Behavior Intervention | Change in PANAS Scores (Primary Psychological Outcome) | 24 weeks | 5.43 units on a scale | Standard Deviation 5.15 |
| MI-based Educational Control Condition | Change in PANAS Scores (Primary Psychological Outcome) | 12 weeks | 2.50 units on a scale | Standard Deviation 8.26 |
| MI-based Educational Control Condition | Change in PANAS Scores (Primary Psychological Outcome) | 24 weeks | -0.46 units on a scale | Standard Deviation 7.29 |
| Treatment as Usual (TAU) | Change in PANAS Scores (Primary Psychological Outcome) | 12 weeks | 2.50 units on a scale | Standard Deviation 5.6 |
| Treatment as Usual (TAU) | Change in PANAS Scores (Primary Psychological Outcome) | 24 weeks | 3.75 units on a scale | Standard Deviation 7.44 |
Secondary
Change in Physical Activity
Assessed by ActiGraph GT3X+ step counters which are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. We will measure both number of steps per day (primary physical health outcome). Change scores will be calculated by subtracting the number of steps per day at baseline from number of steps per day at 12 weeks and 24 weeks.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: Not all participants provided wore Actigraph GT3X+ step counters or provided follow-up data at both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PP-based Health Behavior Intervention | Change in Physical Activity | 12 weeks | 454 steps/day | Standard Deviation 1066 |
| PP-based Health Behavior Intervention | Change in Physical Activity | 24 weeks | 821 steps/day | Standard Deviation 2232 |
| MI-based Educational Control Condition | Change in Physical Activity | 12 weeks | 409 steps/day | Standard Deviation 1033 |
| MI-based Educational Control Condition | Change in Physical Activity | 24 weeks | -330 steps/day | Standard Deviation 1287 |
| Treatment as Usual (TAU) | Change in Physical Activity | 12 weeks | -412 steps/day | Standard Deviation 1305 |
| Treatment as Usual (TAU) | Change in Physical Activity | 24 weeks | 76 steps/day | Standard Deviation 1207 |
Secondary
Changes in HADS-Anxiety Subscale Scores
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 12 weeks and 24 weeks. Higher scores indicate higher levels of anxiety.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: Not all participants provided follow-up data at both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PP-based Health Behavior Intervention | Changes in HADS-Anxiety Subscale Scores | 24 weeks | -2.21 units on a scale | Standard Deviation 1.72 |
| PP-based Health Behavior Intervention | Changes in HADS-Anxiety Subscale Scores | 12 weeks | -1.79 units on a scale | Standard Deviation 3.42 |
| MI-based Educational Control Condition | Changes in HADS-Anxiety Subscale Scores | 12 weeks | -2.00 units on a scale | Standard Deviation 2.54 |
| MI-based Educational Control Condition | Changes in HADS-Anxiety Subscale Scores | 24 weeks | -1.69 units on a scale | Standard Deviation 3.47 |
| Treatment as Usual (TAU) | Changes in HADS-Anxiety Subscale Scores | 12 weeks | -2.07 units on a scale | Standard Deviation 3.85 |
| Treatment as Usual (TAU) | Changes in HADS-Anxiety Subscale Scores | 24 weeks | -2.50 units on a scale | Standard Deviation 4.44 |
Secondary
Changes in KCCQ Scores (Primary Functional Outcome)
The Kansas City Cardiomyopathy Questionnaire (KCCQ) 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 12 weeks and 24 weeks. Higher QoL scores indicate better HF specific health-related QoL, and higher total symptom scores indicate fewer symptoms.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: Not all participants provided follow-up data at both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PP-based Health Behavior Intervention | Changes in KCCQ Scores (Primary Functional Outcome) | 12 weeks HRQoL | 7.74 units on a scale | Standard Deviation 24.99 |
| PP-based Health Behavior Intervention | Changes in KCCQ Scores (Primary Functional Outcome) | 12 weeks Total Symptom | 2.31 units on a scale | Standard Deviation 21.39 |
| PP-based Health Behavior Intervention | Changes in KCCQ Scores (Primary Functional Outcome) | 24 weeks HRQoL | 1.19 units on a scale | Standard Deviation 22.13 |
| PP-based Health Behavior Intervention | Changes in KCCQ Scores (Primary Functional Outcome) | 24 weeks Total Symptom | 1.93 units on a scale | Standard Deviation 18.49 |
| MI-based Educational Control Condition | Changes in KCCQ Scores (Primary Functional Outcome) | 24 weeks Total Symptom | -5.37 units on a scale | Standard Deviation 14.14 |
| MI-based Educational Control Condition | Changes in KCCQ Scores (Primary Functional Outcome) | 12 weeks HRQoL | 4.76 units on a scale | Standard Deviation 23.28 |
| MI-based Educational Control Condition | Changes in KCCQ Scores (Primary Functional Outcome) | 24 weeks HRQoL | 7.05 units on a scale | Standard Deviation 26.75 |
| MI-based Educational Control Condition | Changes in KCCQ Scores (Primary Functional Outcome) | 12 weeks Total Symptom | -1.19 units on a scale | Standard Deviation 10.89 |
| Treatment as Usual (TAU) | Changes in KCCQ Scores (Primary Functional Outcome) | 24 weeks Total Symptom | 0.87 units on a scale | Standard Deviation 16.66 |
| Treatment as Usual (TAU) | Changes in KCCQ Scores (Primary Functional Outcome) | 12 weeks Total Symptom | 2.60 units on a scale | Standard Deviation 16.65 |
| Treatment as Usual (TAU) | Changes in KCCQ Scores (Primary Functional Outcome) | 24 weeks HRQoL | 10.42 units on a scale | Standard Deviation 12.87 |
| Treatment as Usual (TAU) | Changes in KCCQ Scores (Primary Functional Outcome) | 12 weeks HRQoL | 10.12 units on a scale | Standard Deviation 13.94 |
Secondary
Changes in LOT-R Scores
Life Orientation Test-Revised (LOT-R) 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 12 and 24 weeks. Higher scores indicate higher levels of dispositional optimism.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: Not all participants provided follow-up data at both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PP-based Health Behavior Intervention | Changes in LOT-R Scores | 12 weeks | 2.43 units on a scale | Standard Deviation 4.18 |
| PP-based Health Behavior Intervention | Changes in LOT-R Scores | 24 weeks | 3.50 units on a scale | Standard Deviation 3.35 |
| MI-based Educational Control Condition | Changes in LOT-R Scores | 12 weeks | 1.29 units on a scale | Standard Deviation 3.05 |
| MI-based Educational Control Condition | Changes in LOT-R Scores | 24 weeks | 1.23 units on a scale | Standard Deviation 4.66 |
| Treatment as Usual (TAU) | Changes in LOT-R Scores | 12 weeks | 2.93 units on a scale | Standard Deviation 5.92 |
| Treatment as Usual (TAU) | Changes in LOT-R Scores | 24 weeks | 2.83 units on a scale | Standard Deviation 6.62 |
Secondary
Changes in MOS SAS Scores
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 12 weeks and 24 weeks. Higher scores indicate better adherence to health behaviors.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: Not all participants provided follow-up data at both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PP-based Health Behavior Intervention | Changes in MOS SAS Scores | 12 weeks | 2.50 units on a scale | Standard Deviation 2.59 |
| PP-based Health Behavior Intervention | Changes in MOS SAS Scores | 24 weeks | 2.29 units on a scale | Standard Deviation 2.81 |
| MI-based Educational Control Condition | Changes in MOS SAS Scores | 12 weeks | 2.64 units on a scale | Standard Deviation 2.27 |
| MI-based Educational Control Condition | Changes in MOS SAS Scores | 24 weeks | 2.23 units on a scale | Standard Deviation 3.56 |
| Treatment as Usual (TAU) | Changes in MOS SAS Scores | 12 weeks | 1.14 units on a scale | Standard Deviation 2.38 |
| Treatment as Usual (TAU) | Changes in MOS SAS Scores | 24 weeks | 1.42 units on a scale | Standard Deviation 1.73 |
Secondary
Changes in Self-Reported Medication Adherence (SRMA)
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: 0-100). Change was calculated by subtracting the score at baseline from the score at 10 weeks.
Time frame: Baseline, 12 weeks and 24 weeks
Population: Not all participants provided follow-up data at both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PP-based Health Behavior Intervention | Changes in Self-Reported Medication Adherence (SRMA) | 12 weeks | 43 percentage of time | Standard Deviation 51 |
| PP-based Health Behavior Intervention | Changes in Self-Reported Medication Adherence (SRMA) | 24 weeks | 36 percentage of time | Standard Deviation 50 |
| MI-based Educational Control Condition | Changes in Self-Reported Medication Adherence (SRMA) | 12 weeks | 0 percentage of time | Standard Deviation 39 |
| MI-based Educational Control Condition | Changes in Self-Reported Medication Adherence (SRMA) | 24 weeks | 8 percentage of time | Standard Deviation 64 |
| Treatment as Usual (TAU) | Changes in Self-Reported Medication Adherence (SRMA) | 12 weeks | 21 percentage of time | Standard Deviation 70 |
| Treatment as Usual (TAU) | Changes in Self-Reported Medication Adherence (SRMA) | 24 weeks | 8 percentage of time | Standard Deviation 100 |
Secondary
Changes in SF-12 Scores
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 12 weeks and 24 weeks. Higher scores indicate higher level of health related QoL.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: Not all participants provided follow-up data at both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PP-based Health Behavior Intervention | Changes in SF-12 Scores | 12 weeks Mental Health Composite Score | 7.03 units on a scale | Standard Deviation 9.94 |
| PP-based Health Behavior Intervention | Changes in SF-12 Scores | 24 weeks Mental Health Composite Score | 7.54 units on a scale | Standard Deviation 9.61 |
| PP-based Health Behavior Intervention | Changes in SF-12 Scores | 12 weeks Physical Health Composite Score | 1.88 units on a scale | Standard Deviation 9.22 |
| PP-based Health Behavior Intervention | Changes in SF-12 Scores | 24 weeks Physical Health Composite Score | 2.13 units on a scale | Standard Deviation 10.07 |
| MI-based Educational Control Condition | Changes in SF-12 Scores | 24 weeks Mental Health Composite Score | -1.36 units on a scale | Standard Deviation 11.32 |
| MI-based Educational Control Condition | Changes in SF-12 Scores | 12 weeks Mental Health Composite Score | 1.51 units on a scale | Standard Deviation 8.39 |
| MI-based Educational Control Condition | Changes in SF-12 Scores | 24 weeks Physical Health Composite Score | 1.00 units on a scale | Standard Deviation 8.27 |
| MI-based Educational Control Condition | Changes in SF-12 Scores | 12 weeks Physical Health Composite Score | 0.42 units on a scale | Standard Deviation 7.18 |
| Treatment as Usual (TAU) | Changes in SF-12 Scores | 24 weeks Mental Health Composite Score | 8.28 units on a scale | Standard Deviation 8.73 |
| Treatment as Usual (TAU) | Changes in SF-12 Scores | 12 weeks Physical Health Composite Score | 0.83 units on a scale | Standard Deviation 10.61 |
| Treatment as Usual (TAU) | Changes in SF-12 Scores | 24 weeks Physical Health Composite Score | 0.75 units on a scale | Standard Deviation 11.3 |
| Treatment as Usual (TAU) | Changes in SF-12 Scores | 12 weeks Mental Health Composite Score | 5.19 units on a scale | Standard Deviation 5.73 |
Secondary
Changes in Sodium Intake (as Measured With the SSQ)
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 12 weeks and 24 weeks. Higher scores indicate higher sodium intake.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: Not all participants provided follow-up data at both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PP-based Health Behavior Intervention | Changes in Sodium Intake (as Measured With the SSQ) | 24 weeks | -13.18 units on a scale | Standard Deviation 20.14 |
| PP-based Health Behavior Intervention | Changes in Sodium Intake (as Measured With the SSQ) | 12 weeks | -18.25 units on a scale | Standard Deviation 17.62 |
| MI-based Educational Control Condition | Changes in Sodium Intake (as Measured With the SSQ) | 12 weeks | -12.93 units on a scale | Standard Deviation 15.9 |
| MI-based Educational Control Condition | Changes in Sodium Intake (as Measured With the SSQ) | 24 weeks | -14.65 units on a scale | Standard Deviation 20.26 |
| Treatment as Usual (TAU) | Changes in Sodium Intake (as Measured With the SSQ) | 12 weeks | -11.68 units on a scale | Standard Deviation 19.77 |
| Treatment as Usual (TAU) | Changes in Sodium Intake (as Measured With the SSQ) | 24 weeks | -0.63 units on a scale | Standard Deviation 23.95 |
Secondary
Changes in SOM Scores
The State Optimism Measure (SOM) will be used to measure state optimism (Range: 7-35). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of state optimism.
Time frame: Baseline, 12 weeks, and 24 weeks
Population: Not all participants provided follow-up data at both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PP-based Health Behavior Intervention | Changes in SOM Scores | 12 weeks | 2.14 units on a scale | Standard Deviation 4.38 |
| PP-based Health Behavior Intervention | Changes in SOM Scores | 24 weeks | 2.00 units on a scale | Standard Deviation 4.61 |
| MI-based Educational Control Condition | Changes in SOM Scores | 12 weeks | 1.29 units on a scale | Standard Deviation 4.63 |
| MI-based Educational Control Condition | Changes in SOM Scores | 24 weeks | 1.38 units on a scale | Standard Deviation 5.74 |
| Treatment as Usual (TAU) | Changes in SOM Scores | 12 weeks | 2.36 units on a scale | Standard Deviation 3.97 |
| Treatment as Usual (TAU) | Changes in SOM Scores | 24 weeks | -0.17 units on a scale | Standard Deviation 5.61 |
Secondary
Feasibility of Actigraph
Feasibility will be measured by examining the number of participants who provide adequate Actigraph data, defined in this study as at least 480 minutes for 5 days, at each time point.
Time frame: Baseline, 12 weeks and 24 weeks
Population: Not all participants provided wore Actigraph GT3X+ step counters or provided follow-up data at both timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PP-based Health Behavior Intervention | Feasibility of Actigraph | 24 weeks | 12 Participants with adequate activity data |
| PP-based Health Behavior Intervention | Feasibility of Actigraph | 12 weeks | 11 Participants with adequate activity data |
| MI-based Educational Control Condition | Feasibility of Actigraph | 24 weeks | 11 Participants with adequate activity data |
| MI-based Educational Control Condition | Feasibility of Actigraph | 12 weeks | 13 Participants with adequate activity data |
| Treatment as Usual (TAU) | Feasibility of Actigraph | 24 weeks | 10 Participants with adequate activity data |
| Treatment as Usual (TAU) | Feasibility of Actigraph | 12 weeks | 11 Participants with adequate activity data |
Secondary
Immediate Impact of the Exercises
Participants receiving the PP-based health behavior intervention will provide ratings of optimism and positive affect, before and after each exercise, measured on a 10-point Likert scale.
Time frame: Weekly, up to 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PP-based Health Behavior Intervention | Immediate Impact of the Exercises | Optimism | 0.64 units on a scale | Standard Deviation 1.14 |
| PP-based Health Behavior Intervention | Immediate Impact of the Exercises | Positive Affect | 0.97 units on a scale | Standard Deviation 1.38 |