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 our customized positive psychology (PP)-based health behavior intervention in a group of patients with mild to moderate heart failure (HF).
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.
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 exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.
Sponsors
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the PP-based Health Behavior Intervention | 10 weeks | Feasibility will be measured by examining the number of completed exercises. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Change in Physical Activity | Baseline and 10 weeks | Measured by Actigraph accelerometer, in number of steps per day. |
| 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. |
| Feasibility of Actigraph | Baseline and 10 weeks | Feasibility will be measured by examining the number of participants who use of the Actigraph. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Intervention Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Feasibility of Actigraph | 9 Participants |
| Hospital Anxiety and Depression Scale (HADS) anxiety subscale | 4.20 units on a scale STANDARD_DEVIATION 2.2 |
| Hospital Anxiety and Depression Scale (HADS) depression subscale | 1.40 units on a scale STANDARD_DEVIATION 1.26 |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) HRQoL score | 85.83 units on a scale STANDARD_DEVIATION 11.82 |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom score | 84.06 units on a scale STANDARD_DEVIATION 15.43 |
| Life Orientation Test-Revised (LOT-R) | 20.90 units on a scale STANDARD_DEVIATION 2.42 |
| Medical Outcomes Study Short Form-12 (SF-12) Mental Health Composite Score | 53.57 units on a scale STANDARD_DEVIATION 6.25 |
| Medical Outcomes Study Short Form-12 (SF-12) Physical Health Composite Score | 49.15 units on a scale STANDARD_DEVIATION 8.05 |
| Medical Outcomes Study Specific Adherence Scale (MOS SAS) | 12.70 units on a scale STANDARD_DEVIATION 1.34 |
| Moderate to Vigorous Physical Activity (measured via Actigraph) | 28.89 minutes/day STANDARD_DEVIATION 45.29 |
| Physical Activity | 6435 steps/day STANDARD_DEVIATION 6649 |
| Positive and Negative Affect Schedule (PANAS) | 38.70 units on a scale STANDARD_DEVIATION 3.53 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 10 participants |
| Scored Sodium Questionnaire (SSQ) | 56.70 units on a scale STANDARD_DEVIATION 22.38 |
| Self-Reported Medication Adherence (SRMA) | 96.00 percentage STANDARD_DEVIATION 5.16 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 2 / 10 |
Outcome results
Primary
Feasibility of the PP-based Health Behavior Intervention
Feasibility will be measured by examining the number of completed exercises.
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Feasibility of the PP-based Health Behavior Intervention | 7.8 Exercises Completed | Standard Deviation 2.7 |
Secondary
Acceptability of the Exercises: Ease Score
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Acceptability of the Exercises: Ease Score | 7.5 units on a scale | Standard Deviation 2.1 |
Secondary
Acceptability of the Exercises: Utility Score
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Acceptability of the Exercises: Utility Score | 7.8 units on a scale | Standard Deviation 1.8 |
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 10 weeks. Higher scores indicate worse outcome (i.e. greater levels of depression).
Time frame: Change in score from Baseline to 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change in HADS-Depression Subscale Scores | .11 units on a scale | Standard Deviation 1.17 |
Secondary
Change in Moderate to Vigorous Physical Activity (Actigraph)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change in Moderate to Vigorous Physical Activity (Actigraph) | .15 minutes/day | Standard Deviation 9.97 |
Secondary
Change in Physical Activity
Measured by Actigraph accelerometer, in number of steps per day.
Time frame: Baseline and 10 weeks
Population: Not all participants wore the Actigraph and provided adequate data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change in Physical Activity | 706 steps/day | Standard Deviation 1616 |
Secondary
Changes in Daily 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 10 weeks. Higher scores indicate higher sodium intake.
Time frame: Change in score from Baseline to 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Changes in Daily Sodium Intake (as Measured With the SSQ) | 16.31 units on a scale | Standard Deviation 18.92 |
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 10 weeks. Higher scores indicate higher levels of anxiety.
Time frame: Change in score from Baseline to 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Changes in HADS-Anxiety Subscale Scores | 2.0 units on a scale | Standard Deviation 2.18 |
Secondary
Changes in KCCQ Scores
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in KCCQ Scores | HRQoL score | 5.56 units on a scale | Standard Deviation 10.21 |
| Intervention Arm | Changes in KCCQ Scores | Total Symptom score | 6.60 units on a scale | Standard Deviation 10.44 |
Secondary
Changes in LOT-R Scores
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Changes in LOT-R Scores | 1.56 units on a scale | Standard Deviation 1.94 |
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 10 weeks. Higher scores indicate better adherence to health behaviors.
Time frame: Change in score from Baseline to 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Changes in MOS SAS Scores | 2.78 units on a scale | Standard Deviation 2.33 |
Secondary
Changes in PANAS Scores
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Changes in PANAS Scores | 2.44 units on a scale | Standard Deviation 3.54 |
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 10 weeks. Higher scores indicate higher level of health related QoL.
Time frame: Change in score from Baseline to 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Changes in SF-12 Scores | Physical Health Composite Score | 2.44 units on a scale | Standard Deviation 7.38 |
| Intervention Arm | Changes in SF-12 Scores | Metal Health Composite Score | 2.17 units on a scale | Standard Deviation 6.65 |
Secondary
Feasibility of Actigraph
Feasibility will be measured by examining the number of participants who use of the Actigraph.
Time frame: Baseline and 10 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Feasibility of Actigraph | Baseline Actigraph | 9 Participants |
| Intervention Arm | Feasibility of Actigraph | 10 Week Actigraph | 8 Participants |
Secondary
Immediate Impact of the Exercises: Optimism Rating
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Immediate Impact of the Exercises: Optimism Rating | Pre-Exercise Rating | 8.2 units on a scale | Standard Deviation 1.5 |
| Intervention Arm | Immediate Impact of the Exercises: Optimism Rating | Post-Exercise Rating | 8.4 units on a scale | Standard Deviation 1.3 |
Secondary
Immediate Impact of the Exercises: Positive Affect Rating
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Immediate Impact of the Exercises: Positive Affect Rating | Pre-Exercise Rating | 7.8 units on a scale | Standard Deviation 1.5 |
| Intervention Arm | Immediate Impact of the Exercises: Positive Affect Rating | Post-Exercise Rating | 8.6 units on a scale | Standard Deviation 1.1 |
Secondary
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: 0-10). 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Self-Reported Medication Adherence (SRMA) | .44 percentage of time | Standard Deviation 0.53 |