Researching Emotions And Cardiac Health

Not Applicable

Completed

• Conditions: Congestive Heart Failure; Emotions; Patient Compliance

• Registration Number: NCT02737761
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-08
• Study First Posted: 2016-04-14
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Themes related to how deficits in positive emotional states are associated with health behavior adherence	Qualitative data collected at Baseline	Subjects will complete a structured interview at baseline, providing information about their own positive emotional states, identifying strategies to enhance positive emotions, linking the presence of positive emotions to better adherence to health-related behaviors, and identifying additional barriers (e.g., logistic, financial) to completing such behaviors.

Secondary Outcome Measures

Name	Time	Method
Feasibility of MEMSCaps	Baseline and 12 weeks	Feasibility will be measured by examining the rates of use of the MEMSCap.
Changes in LOT-R Scores	Baseline, 12 weeks	Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism.
Changes in HADS Scores	Baseline, 12 weeks	The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.
Changes in PANAS Scores	Baseline, 12 weeks	The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect.
Changes in MOS SAS Scores	Baseline, 12 weeks	Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score.
Changes in daily sodium intake (as measured with the ASA24)	Baseline, 12 weeks	The Automated Self-administered 24-hour recall (ASA24) is an online assessment tool based on the U.S. Department of Agriculture's (USDA) Automated Multi-Pass Method (AMPM). It will be used to calculate daily sodium intake.
Changes in KCCQ Scores	Baseline, 12 weeks	The Kansas City Cardiomyopathy Questionnaire is a well-validated questionnaire of health status in HF. The full scale will be used to measure HF-specific health-related QoL (HRQoL), and an eight-question subset of the KCCQ will be used as a measure of HF symptoms.
Changes in SF-12 Scores	Baseline, 12 weeks	The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past.
Medication Adherence (MEMSCaps)	12 weeks	The MEMSCap has been used in patients with HF and is the most prevalent system for measuring adherence to PO medications. Investigators will measure adherence to a once-daily prescribed medication (aspirin, thiazide diuretic, statin, ACE inhibitor, or another once-daily cardiac medication, chosen in that order). Data will be continuously collected, and adherence noted by presence of bottle opening each day. Participants will use the pill counter throughout the study.
Physical Activity Adherence (Actigraph)	12 weeks	ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer to assess the feasibility of doing so and to ensure adequate capture of physical activity.
Feasibility of Actigraph	Baseline and 12 weeks	Feasibility will be measured by examining the rates of use of the Actigraph.
Themes related to how deficits in positive emotional states are associated with health behavior adherence at 12 weeks	Qualitative data collected at 12 weeks	Subjects will complete a structured interview at 12 weeks, providing information about their own positive emotional states, identifying strategies to enhance positive emotions, linking the presence of positive emotions to better adherence to health-related behaviors, and identifying additional barriers (e.g., logistic, financial) to completing such behaviors.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States