Researching Emotions And Cardiac Health (REACH): Phase II

Congestive Heart Failure Clinical Trial

— REACH II  

Official title:

Developing a Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: proof-of Concept Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938052
• Other study ID #: 2016P001443
• Secondary ID: 1K23HL123607-01A
• Status: Completed
• Phase: N/A
• Start date: December 6, 2016
• Est. completion date: August 10, 2017

Study information

• Verified date: August 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 10, 2017
• Est. primary completion date: July 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Emotions
• Heart Failure
• Patient Compliance

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the PP-based Health Behavior Intervention	Feasibility will be measured by examining the number of completed exercises.	10 weeks
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.	Change in score from Baseline to 10 weeks
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.	Change of score from Baseline to 10 weeks
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.	Change in score from Baseline to 10 weeks
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).	Change in score from Baseline to 10 weeks
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.	Change in score from Baseline to 10 weeks
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.	Change in score from Baseline to 10 weeks
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.	Change in score from Baseline to 10 weeks
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.	Change in score from Baseline to 10 weeks
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.	Change in score from Baseline to 10 weeks
Secondary	Change in Physical Activity	Measured by Actigraph accelerometer, in number of steps per day.	Baseline and 10 weeks
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.	Change in MVPA from Baseline to 10 weeks
Secondary	Feasibility of Actigraph	Feasibility will be measured by examining the number of participants who use of the Actigraph.	Baseline and 10 weeks
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.	Weeks 1-10
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.	Weeks 1-10
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.	Weeks 1-10
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.	Weeks 1-10