Ignite Creation Date:
2024-05-06 @ 12:58 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01709669
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2012-09-21
Brief Title:
The Impact of Gratitude on Biology and Behavior in Persons With Heart Disease
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
The Impact of Gratitude on Biology and Behavior in Persons With Heart Disease
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRACE
Brief 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 gratitudeoptimism 2 weeks after ACS and improvement in biological markers of cardiac health at 6 months post-ACS
Hypothesis Higher levels of gratitudeoptimism 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 gratitudeoptimism 2 weeks after ACS and subsequent adherence to health behaviors known to improve post-ACS prognosis at 6 months
Hypothesis Higher levels of gratitudeoptimism 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 gratitudeoptimism at 2 weeks and non-elective cardiac rehospitalizations and other clinical outcomes at 6 months
Hypothesis Higher levels of gratitudeoptimism 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
Specific Aim 1 To prospectively assess the association between gratitudeoptimism 2 weeks after ACS and improvement in biological markers of cardiac health at 6 months post-ACS
Hypothesis Higher levels of gratitudeoptimism 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 gratitudeoptimism 2 weeks after ACS and subsequent adherence to health behaviors known to improve post-ACS prognosis at 6 months
Hypothesis Higher levels of gratitudeoptimism 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 gratitudeoptimism at 2 weeks and non-elective cardiac rehospitalizations and other clinical outcomes at 6 months
Hypothesis Higher levels of gratitudeoptimism 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
Detailed Description:
Enrollment Patients will be enrolled during their acute admission for an ACS At this visit patients will be introduced to the study and given a follow-up study visit at the MGH Heart Center 2 weeks following their ACS We will also ask them about their physical activity levels in the time before their ACS
On the date of enrollment study staff will estimate baseline physical activity using the Stanford 7-day Physical Activity Recall Scale PAR Additionally contact information address phone number email will be obtained from the subject along with hisher social security number in order to provide a check for compensation
Initial Evaluation
After enrollment subjects will have a visit 2 weeks post-ACS in the MGH Heart Center Several procedures will occur during this visit
1 Baseline assessments Subjects will complete self-report measures to assess the following
Gratitude will be assessed using the Gratitude Questionnaire-6 GQ-6 The GQ-6 is a brief validated six-item measure of dispositional gratitude
Optimism will be measured using the Life Orientation Test-Revised LOT-R a short 6-item rating scale
Baseline adherence to health behaviors will be measured using items from the MOS Specific Adherence Scale SAS that ask about diet and medication adherence
Baseline medical and functional status will be measured using the MOS Short Form-12 SF-12 The SF-12 is a cardiac symptom scale adapted from the Women and Ischemia Syndrome Evaluation WISE study and the Duke Activity Symptom Index DASI for function
Depression will be measured using the Patient Health Questionnaire-9which is a 9-item scale
Anxiety will be measured using the anxiety subscale of the Hospital Anxiety and Depression Scale HADS-A The HADS-A is a 7-item scale
2 Biomarker collection Subjects will also have a single blood draw 2 tablespoons or 10 mlcc for the following biological factors that are important to cardiac health and may be modified by psychological states A total of 15 mlcc of blood will be drawn
3 Chart review for baseline variables We will review subjects electronic medical record to gather data on sociodemographic variables age gender medical information severity of initial ACS and overall cardiac function
3 month phone call
Three months after enrolling in the study we will call participants to help them test the accelerometer We will also schedule their 6-month study visit and repeat all self-report measures Finally we will remind them to wear the accelerometer for 14 days prior to their 6-month visit and record their physical activity each day for 14 days We will schedule this call at a convenient time for the participant on a weekday weeknight or weekend
Provision of accelerometer
One month before their six-month visit we will mail the Pebble uniaxial accelerometer Fitlinxx Shelton CT to the participant along with an instruction sheet and technical support contact information We will contact subjects shortly after to make sure the accelerometer arrived and we will have them wear the devices for several days to ensure that there are no troubles with fit operation or remembering to use the devices
6 month assessment
Finally subjects will return to the MGH Heart Center Clinic 6 months post-ACS At this assessment we will repeat all self-report measures collect accelerometers draw blood 2 tablespoons or 10 mlcc for biomarkers and inquire about readmissions since enrollment We will gather additional information about readmissions from participants physicians and medical records for this exploratory outcome
On the date of enrollment study staff will estimate baseline physical activity using the Stanford 7-day Physical Activity Recall Scale PAR Additionally contact information address phone number email will be obtained from the subject along with hisher social security number in order to provide a check for compensation
Initial Evaluation
After enrollment subjects will have a visit 2 weeks post-ACS in the MGH Heart Center Several procedures will occur during this visit
1 Baseline assessments Subjects will complete self-report measures to assess the following
Gratitude will be assessed using the Gratitude Questionnaire-6 GQ-6 The GQ-6 is a brief validated six-item measure of dispositional gratitude
Optimism will be measured using the Life Orientation Test-Revised LOT-R a short 6-item rating scale
Baseline adherence to health behaviors will be measured using items from the MOS Specific Adherence Scale SAS that ask about diet and medication adherence
Baseline medical and functional status will be measured using the MOS Short Form-12 SF-12 The SF-12 is a cardiac symptom scale adapted from the Women and Ischemia Syndrome Evaluation WISE study and the Duke Activity Symptom Index DASI for function
Depression will be measured using the Patient Health Questionnaire-9which is a 9-item scale
Anxiety will be measured using the anxiety subscale of the Hospital Anxiety and Depression Scale HADS-A The HADS-A is a 7-item scale
2 Biomarker collection Subjects will also have a single blood draw 2 tablespoons or 10 mlcc for the following biological factors that are important to cardiac health and may be modified by psychological states A total of 15 mlcc of blood will be drawn
3 Chart review for baseline variables We will review subjects electronic medical record to gather data on sociodemographic variables age gender medical information severity of initial ACS and overall cardiac function
3 month phone call
Three months after enrolling in the study we will call participants to help them test the accelerometer We will also schedule their 6-month study visit and repeat all self-report measures Finally we will remind them to wear the accelerometer for 14 days prior to their 6-month visit and record their physical activity each day for 14 days We will schedule this call at a convenient time for the participant on a weekday weeknight or weekend
Provision of accelerometer
One month before their six-month visit we will mail the Pebble uniaxial accelerometer Fitlinxx Shelton CT to the participant along with an instruction sheet and technical support contact information We will contact subjects shortly after to make sure the accelerometer arrived and we will have them wear the devices for several days to ensure that there are no troubles with fit operation or remembering to use the devices
6 month assessment
Finally subjects will return to the MGH Heart Center Clinic 6 months post-ACS At this assessment we will repeat all self-report measures collect accelerometers draw blood 2 tablespoons or 10 mlcc for biomarkers and inquire about readmissions since enrollment We will gather additional information about readmissions from participants physicians and medical records for this exploratory outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None