The Impact of Gratitude on Biology and Behavior in Persons With Heart Disease

Completed

Conditions studied: Myocardial Infarction, Unstable Angina

In brief

Overall, the investigators aim to recruit 150 subjects during their hospitalization for an acute coronary syndrome (ACS). At two weeks post-ACS, the investigators will assess levels of gratitude and optimism, draw blood for baseline levels of biomarkers, gather baseline information about health behaviors critical to cardiac health, and obtain baseline measures of symptoms and function. Finally, the investigators will repeat assessments of biomarkers, behavior, and function at 6 months to allow us to assess the impact of gratitude and optimism on these outcomes; the investigators will also have an objective measure of physical activity via accelerometer (step counter) at 6 months. Specific Aim #1: To prospectively assess the association between gratitude/optimism 2 weeks after ACS and improvement in biological markers of cardiac health at 6 months post-ACS. Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater reductions in levels of biomarkers associated with negative heart health between 2 weeks and 6 months. Specific Aim #2 (\*primary aim\*): To assess the association between gratitude/optimism 2 weeks after ACS and subsequent adherence to health behaviors known to improve post-ACS prognosis at 6 months. Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater amounts of physical activity (measured by accelerometer) at 6 months (primary study outcome measure), and greater improvements in self-reported adherence to health behaviors (activity, diet, and medication) between 2 weeks and 6 months. Specific Aim #3: To assess the association between gratitude/optimism at 2 weeks and non-elective cardiac rehospitalizations (and other clinical outcomes) at 6 months. Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater improvements in depression, health-related quality of life, function, cardiac symptoms, and possibly readmissions, between 2 weeks and 6 months.

Key facts

Study ID

NCT01709669

Run by

Massachusetts General Hospital

People needed

212

Starts

2012-09-01

Expected to finish

2014-08-01

Last updated by the study team

2015-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients admitted to cardiac units at MGH with a primary admission diagnosis of ACS (eligible patients must meet World Health Organization criteria for myocardial infarction or criteria for unstable angina [new-onset angina within 2 months, exacerbation of previous angina with rest pain or with minimal exercise, or angina within 2 weeks of MI]). ACS diagnosis will be clarified with the inpatient care team and adjudicated by co-investigator cardiologist Dr. Januzzi as needed.

You may not qualify if…

• 'Periprocedural' ACS (ACS that occurs in the setting of another medical procedure; such events may occur in the absence of structural heart disease and likely represent a different pathophysiology, course and prognosis than those with 'endogenous' ACS).
• Conditions likely to alter biomarkers of interest (renal failure requiring hemodialysis, inflammatory disease [e.g., systemic lupus erythematosus])
• Condition likely to lead to death within 6 months (e.g. cancer).
• Inability to complete physical activity due to unrelated medical condition (e.g., severe arthritis)
• Inability to complete self-report evaluations due to inability to speak or write in English or due to cognitive deficits (assessed using an established six-item screen).

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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