Researching Emotions And Cardiac Health (REACH)

Mass General Brigham

Status: Completed

Conditions: Patient Compliance; Emotions; Congestive Heart Failure

Treatments: Behavioral: Qualitative Interview and Adherence Measurements

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02737761

2015P000069

1K23HL123607-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of the study is to understand how positive emotions (e.g., optimism, happiness) are associated with health behavior adherence in patients with heart failure (HF), as well as whether performing exercises to improve positive emotions may help to improve health behavior adherence as well.

Full 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 interview 30 HF patients within two weeks of enrollment in the study, and again three months later.

In this project, the investigators hope to do the following:

1. Identify, through qualitative research, deficits in positive emotional and cognitive states in clinically stable patients with New York Heart Association (NYHA) class II or III HF.
2. Examine potential links between positive emotional deficits and impaired health behaviors (low sodium diet, physical activity, medication adherence), as well as links between positive emotional sufficiency and successful health behaviors.
3. Identify other barriers to health behavior completion.
4. Explore strategies to enhance positive emotional and cognitive states in HF patients and inquire about the utility of potential PP exercises in these patients.
5. Develop a preliminary PP-based intervention using the above information.
6. Assess the feasibility of our proposed survey-based measures for adherence, psychological health, and physical health in this group of patients.
7. Explore the feasibility of using methods to objectively measure medication adherence and physical activity (via electronic pillcaps and accelerometers, respectively) in this population.

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 undergo an open-ended, semi-structured interview within 2 weeks of enrollment. The interview will be approximately 1 hour in length, performed by study staff who have been trained in qualitative research methods. Participants will then undergo another qualitative interview and repeat the battery of questionnaires again at 12 weeks.

Participants will wear an Actigraph accelerometer for 2 weeks at Baseline and again at 12 weeks to measure physical activity, and will also use a MEMSCap electronic pill counter throughout the study to measure medication adherence, respectively.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with NYHA class II or III HF admitted to an MGH inpatient unit or outpatients at the MGH Heart Center. Investigators will enroll subjects who develop mild to moderate HF symptoms during activity but not at rest. NYHA class II/III HF patients comprise the majority of subjects in studies that identify links between physical activity and improved exercise capacity, QoL, and survival making them an ideal study population. HF diagnosis, clinical stability, and NYHA class will be clarified with the inpatient or outpatient cardiology team.

Exclusion criteria

• Cognitive deficits impeding a subject'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 subjects.
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Optimal Adherence

Experimental group

Description:

Participants will all undergo a qualitative interview and adherence measurements at baseline and 12 weeks after hospital discharge. In person the participants will receive a MEMSCaps device and an Actigraph accelerometer. They will be asked to begin wearing the accelerometer after their initial interview and to begin using the MEMSCaps device once they arrive at home. Participants will use the MEMSCap throughout the entire study and will wear the Actigraph for 2 weeks at baseline and again at 12 weeks.

Treatment:

Behavioral: Qualitative Interview and Adherence Measurements