Clinical trial NCT02938052: Researching Emotions And Cardiac Health (REACH): Phase II
Official title: Developing a Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: proof-of Concept 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: 2016-10-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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. 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.

Primary outcomes:
measure: Feasibility of the PP-based Health Behavior Intervention
timeFrame: 10 weeks
Secondary outcomes:
measure: Changes in PANAS Scores
timeFrame: Change in score from Baseline to 10 weeks
measure: Changes in LOT-R Scores
timeFrame: Change of score from Baseline to 10 weeks
measure: Changes in HADS-Anxiety Subscale Scores
timeFrame: Change in score from Baseline to 10 weeks
measure: Change in HADS-Depression Subscale Scores
timeFrame: Change in score from Baseline to 10 weeks
measure: Changes in KCCQ Scores
timeFrame: Change in score from Baseline to 10 weeks
measure: Changes in SF-12 Scores
timeFrame: Change in score from Baseline to 10 weeks
measure: Changes in MOS SAS Scores
timeFrame: Change in score from Baseline to 10 weeks
measure: Changes in Daily Sodium Intake (as Measured With the SSQ)
timeFrame: Change in score from Baseline to 10 weeks
measure: Self-Reported Medication Adherence (SRMA)
timeFrame: Change in score from Baseline to 10 weeks
measure: Change in Physical Activity
timeFrame: Baseline and 10 weeks
measure: Change in Moderate to Vigorous Physical Activity (Actigraph)
timeFrame: Change in MVPA from Baseline to 10 weeks
measure: Feasibility of Actigraph
timeFrame: Baseline and 10 weeks
measure: Acceptability of the Exercises: Utility Score
timeFrame: Weeks 1-10
measure: Acceptability of the Exercises: Ease Score
timeFrame: Weeks 1-10
measure: Immediate Impact of the Exercises: Optimism Rating
timeFrame: Weeks 1-10
measure: Immediate Impact of the Exercises: Positive Affect Rating
timeFrame: Weeks 1-10
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christopher M Celano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Celano CM, Freedman ME, Beale EE, Gomez-Bernal F, Huffman JC. A Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: A Proof-of-Concept Trial. J Nerv Ment Dis. 2018 Oct;206(10):800-808. doi: 10.1097/NMD.0000000000000883.