Researching Emotions And Cardiac Health

NCT ID: NCT02737761

Last Updated: 2016-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-08-31

Brief Summary

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.

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 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.

Conditions

Congestive Heart Failure; Emotions; Patient Compliance

Keywords

Heart Failure; Positive Psychology; Adherence to Health Behaviors

Study Design

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

Study Groups

Optimal Adherence

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.

Group Type: EXPERIMENTAL

Qualitative Interview and Adherence Measurements

Intervention Type: BEHAVIORAL

Subjects will undergo an open-ended, semi-structured interview within two weeks of enrollment. The interview will be approximately 1 hour in length, performed by study staff who have been trained in qualitative research methods. This interview will be completed again 12 weeks later. Subjects will complete the MOS SAS, Automated Self-Administered 24-hour recall (ASA24), Life Orientation Test-Revised (LOT-R), Positive and Negative Affect Schedule (PANAS), Hospital Anxiety and Depression Scale (HADS), Kansas City Cardiomyopathy Questionnaire (KCCQ), and Medical Outcomes Study Short Form-12 (SF-12) at baseline and again at 12 weeks.

Interventions

Qualitative Interview and Adherence Measurements

Subjects will undergo an open-ended, semi-structured interview within two weeks of enrollment. The interview will be approximately 1 hour in length, performed by study staff who have been trained in qualitative research methods. This interview will be completed again 12 weeks later. Subjects will complete the MOS SAS, Automated Self-Administered 24-hour recall (ASA24), Life Orientation Test-Revised (LOT-R), Positive and Negative Affect Schedule (PANAS), Hospital Anxiety and Depression Scale (HADS), Kansas City Cardiomyopathy Questionnaire (KCCQ), and Medical Outcomes Study Short Form-12 (SF-12) at baseline and again at 12 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• 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

Instructor 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

Other Identifiers

1K23HL123607-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015P000069

Identifier Type: -

Identifier Source: org_study_id