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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of California, Berkeley
Information provided by (Responsible Party):
Jeff C. Huffman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01709669
First received: September 21, 2012
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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, 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 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 2 weeks after ACS and improvement in biological markers of cardiac health at 6 months post-ACS.

Hypothesis: Higher levels of gratitude 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: To assess the association between gratitude 2 weeks after ACS and subsequent adherence to health behaviors known to improve post-ACS prognosis at 6 months.

Hypothesis: Higher levels of gratitude at 2 weeks will be associated with greater amounts of physical activity (measured by accelerometer) at 6 months, and greater improvements in self-reported adherence to health behaviors (diet and medication) between 2 weeks and 6 months.

Specific Aim #3: To assess the association between gratitude at 2 weeks and other critical medical, functional, and psychological outcomes at 6 months.

Hypothesis: Higher levels of gratitude 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
Myocardial Infarction
Unstable Angina

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Gratitude on Biology and Behavior in Persons With Heart Disease

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in GQ-6 scores [ Time Frame: At 2 weeks, 3 months, and 6 months after ACS ] [ Designated as safety issue: No ]
    The Gratitude Questionnaire 6 is a brief, validated six-item measure of dispositional gratitude.


Secondary Outcome Measures:
  • Change in Biomarkers [ Time Frame: 2 weeks and 6 months after ACS ] [ Designated as safety issue: No ]
    Levels of inflammation (IL-6), endothelial dysfunction (VEGF), cardiac cell damage (high sensitivity troponin T), lipid levels, and overall cardiac prognosis (NT-proBNP)


Other Outcome Measures:
  • Change in Physical Activity [ Time Frame: Intake and 6 months after ACS ] [ Designated as safety issue: No ]
    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.

  • Change in Depression [ Time Frame: 2 weeks, 3 months, and 6 months ] [ Designated as safety issue: No ]
    Patient Health Questionnaire-9 (PHQ-9)

  • Change in Anxiety [ Time Frame: 2 weeks, 3 months, and 6 months ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale (HADS)

  • Change in Health-Related Quality of Life [ Time Frame: 2 weeks, 3 months, and 6 months ] [ Designated as safety issue: No ]
    MOS Short Form-12 (SF-12)

  • Change in Function [ Time Frame: 2 weeks, 3 months, and 6 months ] [ Designated as safety issue: No ]
    Duke Activity Symptom Index (DASI)

  • Change in Cardiac Symptoms [ Time Frame: 2 weeks, 3 months, and 6 months ] [ Designated as safety issue: No ]
    A cardiac symptom scale adapted from the Women and Ischemia Syndrome Evaluation (WISE) study

  • Readmissions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of readmissions to the hospital


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), cardiac ischemia (ongoing heart damage) will be measured via high sensitivity Troponin T (hsTnT), endothelial function/angiogenesis will be measured by vascular endothelial growth factor (VEGF), overall cardiac prognosis will be assessed using N-terminal pro-brain natriuretic peptide (NT-proBNP), and lipid levels will be assessed by a fasting lipid profile. 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.


Estimated Enrollment: 150
Study Start Date: September 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Enrolling by invitation

  Hide Detailed Description

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 (converted to # of steps) 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 his/her 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.
    • 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-9,which is a 9-item scale.
    • Anxiety will be measured using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). The HADS is a 7-item scale.
    • Optimism will be measured using the Life Orientation Test-Revised (LOT-R), a short 6-item rating scale.
    • Spirituality will be measured using 4 brief questions from the Daily Spiritual Experience Scale (DSES).
  2. Biomarker collection. Subjects will also have a single blood draw (2 tablespoons or 10 ml/cc) for the following biological factors that are important to cardiac health and may be modified by psychological states. A total of 15 ml/cc 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 Actiped+ 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 ml/cc) for biomarkers, and inquire about readmissions since enrollment. We will gather additional information about readmissions from participants' physicians and the medical record for this exploratory outcome.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted to the Ellison Cardiac Care Units at Massachusetts General Hospital.

Criteria

Inclusion Criteria:

  • Adult patients admitted to cardiac units at MGH with a primary admission diagnosis of ACS (eligible patients must meet World Health Organization criteria66 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 MI42]). ACS diagnosis will be clarified with the inpatient care team and adjudicated by co-investigator cardiologist Dr. Januzzi as needed.

Exclusion Criteria:

  • '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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709669

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
University of California, Berkeley
Investigators
Principal Investigator: Jeff Huffman, M.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jeff C. Huffman, MD, Medical Director, Blake 11, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01709669     History of Changes
Other Study ID Numbers: 2012P001191
Study First Received: September 21, 2012
Last Updated: April 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
acute coronary syndrome
gratitude
health behavior
myocardial infarction
unstable angina

Additional relevant MeSH terms:
Angina, Unstable
Heart Diseases
Infarction
Myocardial Infarction
Angina Pectoris
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on July 20, 2014