Clinical trial NCT02737761: Researching Emotions And Cardiac Health
Official title: Developing a Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: Qualitative Research Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Emotions
Patient Compliance
Keywords: Heart Failure
Positive Psychology
Adherence to Health Behaviors
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-04-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Themes related to how deficits in positive emotional states are associated with health behavior adherence
timeFrame: Qualitative data collected at Baseline
Secondary outcomes:
measure: Changes in PANAS Scores
timeFrame: Baseline, 12 weeks
measure: Changes in LOT-R Scores
timeFrame: Baseline, 12 weeks
measure: Changes in HADS Scores
timeFrame: Baseline, 12 weeks
measure: Changes in KCCQ Scores
timeFrame: Baseline, 12 weeks
measure: Changes in SF-12 Scores
timeFrame: Baseline, 12 weeks
measure: Changes in MOS SAS Scores
timeFrame: Baseline, 12 weeks
measure: Changes in daily sodium intake (as measured with the ASA24)
timeFrame: Baseline, 12 weeks
measure: Medication Adherence (MEMSCaps)
timeFrame: 12 weeks
measure: Physical Activity Adherence (Actigraph)
timeFrame: 12 weeks
measure: Feasibility of MEMSCaps
timeFrame: Baseline and 12 weeks
measure: Feasibility of Actigraph
timeFrame: Baseline and 12 weeks
measure: Themes related to how deficits in positive emotional states are associated with health behavior adherence at 12 weeks
timeFrame: Qualitative data collected at 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christopher M Celano, MD
role: PRINCIPAL_INVESTIGATOR
References: