Researching Emotions And Cardiac Health (REACH): Phase II

NCT ID: NCT02938052

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-06
• Study Completion Date: 2017-08-10

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.

Conditions

Congestive Heart Failure; Emotions; Patient Compliance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PP-based health behavior intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christopher Celano

Assistant in Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher M Celano, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30273277 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K23HL123607-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016P001443

Identifier Type: -

Identifier Source: org_study_id