The Impact of Gratitude on Biology and Behavior in Persons With Heart Disease (GRACE)
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|ClinicalTrials.gov Identifier: NCT01709669|
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : April 29, 2015
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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.
|Condition or disease|
|Myocardial Infarction Unstable Angina|
|Study Type :||Observational|
|Actual Enrollment :||212 participants|
|Official Title:||The Impact of Gratitude on Biology and Behavior in Persons With Heart Disease|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
|Enrolling by invitation|
- Physical Activity [ Time Frame: Intake and 6 months after ACS ]Subjects' level of physical activity as measured by an activity recall log and number of steps taken over a two week period measured by an accelerometer.
- Biomarkers [ Time Frame: 2 weeks and 6 months after ACS ]Levels of inflammation (IL-6, hsCRP, sCAM-1, TNF-α) and overall cardiac prognosis (NT-proBNP)
- Readmissions (cardiac and all-cause) [ Time Frame: 6 months after ACS ]Non-elective readmissions for cardiac and all causes, ascertained by patient report, report of medical providers, and review of medical records.
- Depression [ Time Frame: 2 weeks, 3 months, and 6 months ]Patient Health Questionnaire-9 (PHQ-9)
- Anxiety [ Time Frame: 2 weeks, 3 months, and 6 months ]Hospital Anxiety and Depression Scale Anxiety Subscale (HADS-A)
- Health-Related Quality of Life [ Time Frame: 2 weeks, 3 months, and 6 months ]MOS Short Form-12 (SF-12)
- Function [ Time Frame: 2 weeks, 3 months, and 6 months ]Duke Activity Symptom Index (DASI)
- Cardiac Symptoms [ Time Frame: 2 weeks, 3 months, and 6 months ]A cardiac symptom scale adapted from the Women and Ischemia Syndrome Evaluation (WISE) study
- Adherence to Medical Recommendations [ Time Frame: 2 weeks, 3 months, and 6 months ]The MOS Specific Adherence Scale (SAS)
Biospecimen Retention: Samples Without DNA
Analyzed Blood Samples:
Subjects will have a blood draw for the following biological factors that are important to cardiac health and may be modified by psychological states: Inflammation will be measured via interleukin-6 (IL-6) and high sensitivity C-reactive protein (hsCRP), soluble intercellular adhesion molecule-1 (sICAM-1), tumor necrosis factor alpha (TNF-α), and overall cardiac prognosis will be assessed using N-terminal pro-brain natriuretic peptide (NT-proBNP). A total of 15 ml/cc of blood will be drawn (this is equivalent to 3 tablespoons of blood).
Retained Blood Samples:
Given that additional, more sensitive/critical markers of cardiac outcomes may be identified in the near future, participants will be given the option to allow us to store their blood samples for additional biomarker analysis.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- '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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709669
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Jeff Huffman, M.D.||Massachusetts General Hospital|
|Responsible Party:||Jeff C. Huffman, MD, Medical Director, Blake 11, Massachusetts General Hospital|
|Other Study ID Numbers:||
|First Posted:||October 18, 2012 Key Record Dates|
|Last Update Posted:||April 29, 2015|
|Last Verified:||March 2015|
acute coronary syndrome