Researching Emotions And Cardiac Health



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2015
End Date:August 2016

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Developing a Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: Qualitative Research Phase

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.

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.

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.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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