Clinical trial NCT03220204: Researching Emotions And Cardiac Health: Phase III
Official title: A Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: a Randomized, Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Emotions
Patient Compliance
Keywords: Heart Failure
Positive Psychology
Adherence to Health Behaviors
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-07-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-blinded, controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of the PP-based Health Behavior Intervention
timeFrame: Change between baseline and 12 weeks
Secondary outcomes:
measure: Acceptability of the Exercises
timeFrame: 12 weeks
measure: Immediate Impact of the Exercises
timeFrame: Weekly, up to 12 weeks
measure: Change in PANAS Scores (Primary Psychological Outcome)
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Changes in LOT-R Scores
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Changes in SOM Scores
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Changes in HADS-Anxiety Subscale Scores
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in HADS-Depression Subscale Scores
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Changes in KCCQ Scores (Primary Functional Outcome)
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Changes in SF-12 Scores
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Changes in MOS SAS Scores
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Changes in Sodium Intake (as Measured With the SSQ)
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Changes in Self-Reported Medication Adherence (SRMA)
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Physical Activity
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in Moderate to Vigorous Physical Activity
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Feasibility of Actigraph
timeFrame: Baseline, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christopher Celano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Celano CM, Freedman ME, Harnedy LE, Park ER, Januzzi JL, Healy BC, Huffman JC. Feasibility and preliminary efficacy of a positive psychology-based intervention to promote health behaviors in heart failure: The REACH for Health study. J Psychosom Res. 2020 Dec;139:110285. doi: 10.1016/j.jpsychores.2020.110285. Epub 2020 Oct 29.