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NCT01709669 · ClinicalTrials.gov registry record
The Impact of Gratitude on Biology and Behavior in Persons With Heart Disease
A clinical trial, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 212
- Enrollment target
NCT01709669: Completed study, sponsored by Massachusetts General Hospital.
NCT01709669 is a clinical trial that has completed, run by Massachusetts General Hospital. The registered enrollment target is 212 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01709669 has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 212 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-08 |
What the finished NCT01709669 record still lists
NCT01709669 is an observational study that tracks outcomes without assigning an intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01709669 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01709669 about?
NCT01709669 is a clinical study titled "The Impact of Gratitude on Biology and Behavior in Persons With Heart Disease". 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 beha...
What is the current status of trial NCT01709669?
This trial is currently completed. The enrollment target is 212 participants. The study started on 2012-09. Estimated completion is 2014-08.
Who is sponsoring clinical trial NCT01709669?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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