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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01709669
Other study ID # 2012P001191
Secondary ID
Status Completed
Phase N/A
First received September 21, 2012
Last updated April 28, 2015
Start date September 2012
Est. completion date August 2014

Study information

Verified date March 2015
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Description:

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Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Depression Patient Health Questionnaire-9 (PHQ-9) 2 weeks, 3 months, and 6 months No
Other Anxiety Hospital Anxiety and Depression Scale Anxiety Subscale (HADS-A) 2 weeks, 3 months, and 6 months No
Other Health-Related Quality of Life MOS Short Form-12 (SF-12) 2 weeks, 3 months, and 6 months No
Other Function Duke Activity Symptom Index (DASI) 2 weeks, 3 months, and 6 months No
Other Cardiac Symptoms A cardiac symptom scale adapted from the Women and Ischemia Syndrome Evaluation (WISE) study 2 weeks, 3 months, and 6 months No
Other Adherence to Medical Recommendations The MOS Specific Adherence Scale (SAS) 2 weeks, 3 months, and 6 months No
Primary Physical Activity 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. Intake and 6 months after ACS No
Secondary Biomarkers Levels of inflammation (IL-6, hsCRP, sCAM-1, TNF-a) and overall cardiac prognosis (NT-proBNP) 2 weeks and 6 months after ACS No
Secondary Readmissions (cardiac and all-cause) Non-elective readmissions for cardiac and all causes, ascertained by patient report, report of medical providers, and review of medical records. 6 months after ACS No
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