Researching Emotions And Cardiac Health (REACH): Phase II

NCT02938052 | Completed Results DMC

• 2 other identifiers: 2016P0014431K23HL123607-01A1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Congestive Heart Failure; Emotions; Patient Compliance

Keywords

Heart Failure; Positive Psychology; Adherence to Health Behaviors

Outcome Measures

Primary Outcomes (1)

• Feasibility of the PP-based Health Behavior Intervention

  Feasibility will be measured by examining the number of completed exercises.

  10 weeks

Secondary Outcomes (16)

• Changes in PANAS Scores

  Change in score from Baseline to 10 weeks

• Changes in LOT-R Scores

  Change of score from Baseline to 10 weeks

• Changes in HADS-Anxiety Subscale Scores

  Change in score from Baseline to 10 weeks

• Change in HADS-Depression Subscale Scores

  Change in score from Baseline to 10 weeks

• Changes in KCCQ Scores

  Change in score from Baseline to 10 weeks

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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.

Behavioral: PP-based health behavior intervention

Interventions

PP-based health behavior intervention 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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 30273277 DERIVED

MeSH Terms

Conditions

Heart Failure; Patient Compliance

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Was performed at a single academic medical center and had a largely White population. It was a small sample size and there was no control condition in this initial trial.

Results Point of Contact

• Title: Dr. Christopher Celano
• Organization: Massachusetts General Hospital

ccelano@partners.org

617-726-6485

Study Officials

• Christopher M Celano, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Psychiatry

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 19, 2016
• Study Start: December 6, 2016
• Primary Completion: July 24, 2017
• Study Completion: August 10, 2017
• Last Updated: September 1, 2021
• Results First Posted: September 19, 2018

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)