Researching Emotions And Cardiac Health: Phase III

Congestive Heart Failure Clinical Trial

— REACH III  

Official title:

A Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: a Randomized, Controlled Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03220204
• Other study ID #: 5K23HL123607-03
• Secondary ID: 5K23HL123607-03
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: September 9, 2019

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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 9, 2019
• Est. primary completion date: May 20, 2019
• 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 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.

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 portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.
• 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.

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 for individuals randomized to the Positive Psychology (PP)-based intervention.	Change between baseline and 12 weeks
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.	12 weeks
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.	Weekly, up to 12 weeks
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.	Baseline, 12 weeks, and 24 weeks
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.	Baseline, 12 weeks, and 24 weeks
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.	Baseline, 12 weeks, and 24 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 12 weeks and 24 weeks. Higher scores indicate higher levels of anxiety.	Baseline, 12 weeks, and 24 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 12 weeks and 24 weeks. Higher scores indicate higher levels of depression.	Baseline, 12 weeks, and 24 weeks
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.	Baseline, 12 weeks, and 24 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 12 weeks and 24 weeks. Higher scores indicate higher level of health related QoL.	Baseline, 12 weeks, and 24 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 12 weeks and 24 weeks. Higher scores indicate better adherence to health behaviors.	Baseline, 12 weeks, and 24 weeks
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.	Baseline, 12 weeks, and 24 weeks
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.	Baseline, 12 weeks and 24 weeks
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.	Baseline, 12 weeks, and 24 weeks
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.	Baseline, 12 weeks, and 24 weeks
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.	Baseline, 12 weeks and 24 weeks