<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01709669</url>
  </required_header>
  <id_info>
    <org_study_id>2012P001191</org_study_id>
    <nct_id>NCT01709669</nct_id>
  </id_info>
  <brief_title>The Impact of Gratitude on Biology and Behavior in Persons With Heart Disease</brief_title>
  <acronym>GRACE</acronym>
  <official_title>The Impact of Gratitude on Biology and Behavior in Persons With Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Berkeley</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Overall, the investigators aim to recruit 150 subjects during their hospitalization for an&#xD;
      acute coronary syndrome (ACS). At two weeks post-ACS, the investigators will assess levels of&#xD;
      gratitude and optimism, draw blood for baseline levels of biomarkers, gather baseline&#xD;
      information about health behaviors critical to cardiac health, and obtain baseline measures&#xD;
      of symptoms and function. Finally, the investigators will repeat assessments of biomarkers,&#xD;
      behavior, and function at 6 months to allow us to assess the impact of gratitude and optimism&#xD;
      on these outcomes; the investigators will also have an objective measure of physical activity&#xD;
      via accelerometer (step counter) at 6 months.&#xD;
&#xD;
      Specific Aim #1: To prospectively assess the association between gratitude/optimism 2 weeks&#xD;
      after ACS and improvement in biological markers of cardiac health at 6 months post-ACS.&#xD;
&#xD;
      Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater&#xD;
      reductions in levels of biomarkers associated with negative heart health between 2 weeks and&#xD;
      6 months.&#xD;
&#xD;
      Specific Aim #2 (*primary aim*): To assess the association between gratitude/optimism 2 weeks&#xD;
      after ACS and subsequent adherence to health behaviors known to improve post-ACS prognosis at&#xD;
      6 months.&#xD;
&#xD;
      Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater&#xD;
      amounts of physical activity (measured by accelerometer) at 6 months (primary study outcome&#xD;
      measure), and greater improvements in self-reported adherence to health behaviors (activity,&#xD;
      diet, and medication) between 2 weeks and 6 months.&#xD;
&#xD;
      Specific Aim #3: To assess the association between gratitude/optimism at 2 weeks and&#xD;
      non-elective cardiac rehospitalizations (and other clinical outcomes) at 6 months.&#xD;
&#xD;
      Hypothesis: Higher levels of gratitude/optimism at 2 weeks will be associated with greater&#xD;
      improvements in depression, health-related quality of life, function, cardiac symptoms, and&#xD;
      possibly readmissions, between 2 weeks and 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Enrollment Patients will be enrolled during their acute admission for an ACS. At this visit,&#xD;
      patients will be introduced to the study and given a follow-up study visit at the MGH Heart&#xD;
      Center 2 weeks following their ACS. We will also ask them about their physical activity&#xD;
      levels in the time before their ACS.&#xD;
&#xD;
      On the date of enrollment, study staff will estimate baseline physical activity using the&#xD;
      Stanford 7-day Physical Activity Recall Scale (PAR). Additionally, contact information&#xD;
      (address, phone number, email) will be obtained from the subject along with his/her social&#xD;
      security number in order to provide a check for compensation.&#xD;
&#xD;
      Initial Evaluation:&#xD;
&#xD;
      After enrollment, subjects will have a visit 2 weeks post-ACS in the MGH Heart Center.&#xD;
      Several procedures will occur during this visit.&#xD;
&#xD;
        1. Baseline assessments. Subjects will complete self-report measures to assess the&#xD;
           following:&#xD;
&#xD;
             -  Gratitude will be assessed using the Gratitude Questionnaire-6 (GQ-6). The GQ-6 is&#xD;
                a brief, validated six-item measure of dispositional gratitude.&#xD;
&#xD;
             -  Optimism will be measured using the Life Orientation Test-Revised (LOT-R), a short&#xD;
                6-item rating scale.&#xD;
&#xD;
             -  Baseline adherence to health behaviors will be measured using items from the MOS&#xD;
                Specific Adherence Scale (SAS) that ask about diet and medication adherence.&#xD;
&#xD;
             -  Baseline medical and functional status will be measured using the MOS Short Form-12&#xD;
                (SF-12). The SF-12 is a cardiac symptom scale adapted from the Women and Ischemia&#xD;
                Syndrome Evaluation (WISE) study, and the Duke Activity Symptom Index (DASI) for&#xD;
                function.&#xD;
&#xD;
             -  Depression will be measured using the Patient Health Questionnaire-9,which is a&#xD;
                9-item scale.&#xD;
&#xD;
             -  Anxiety will be measured using the anxiety subscale of the Hospital Anxiety and&#xD;
                Depression Scale (HADS-A). The HADS-A is a 7-item scale.&#xD;
&#xD;
        2. Biomarker collection. Subjects will also have a single blood draw (2 tablespoons or 10&#xD;
           ml/cc) for the following biological factors that are important to cardiac health and may&#xD;
           be modified by psychological states. A total of 15 ml/cc of blood will be drawn.&#xD;
&#xD;
        3. Chart review for baseline variables. We will review subjects electronic medical record&#xD;
           to gather data on sociodemographic variables (age, gender), medical information&#xD;
           (severity of initial ACS), and overall cardiac function.&#xD;
&#xD;
      3 month phone call:&#xD;
&#xD;
      Three months after enrolling in the study, we will call participants to help them test the&#xD;
      accelerometer. We will also schedule their 6-month study visit and repeat all self-report&#xD;
      measures. Finally, we will remind them to wear the accelerometer for 14 days prior to their&#xD;
      6-month visit and record their physical activity each day for 14 days. We will schedule this&#xD;
      call at a convenient time for the participant (on a weekday, weeknight, or weekend).&#xD;
&#xD;
      Provision of accelerometer:&#xD;
&#xD;
      One month before their six-month visit, we will mail the Pebble uniaxial accelerometer&#xD;
      (Fitlinxx, Shelton, CT) to the participant, along with an instruction sheet and technical&#xD;
      support contact information. We will contact subjects shortly after to make sure the&#xD;
      accelerometer arrived, and we will have them wear the devices for several days to ensure that&#xD;
      there are no troubles with fit, operation, or remembering to use the devices.&#xD;
&#xD;
      6 month assessment:&#xD;
&#xD;
      Finally, subjects will return to the MGH Heart Center Clinic 6 months post-ACS. At this&#xD;
      assessment, we will repeat all self-report measures, collect accelerometers, draw blood (2&#xD;
      tablespoons or 10 ml/cc) for biomarkers, and inquire about readmissions since enrollment. We&#xD;
      will gather additional information about readmissions from participants' physicians and&#xD;
      medical records for this exploratory outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>Intake and 6 months after ACS</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarkers</measure>
    <time_frame>2 weeks and 6 months after ACS</time_frame>
    <description>Levels of inflammation (IL-6, hsCRP, sCAM-1, TNF-α) and overall cardiac prognosis (NT-proBNP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmissions (cardiac and all-cause)</measure>
    <time_frame>6 months after ACS</time_frame>
    <description>Non-elective readmissions for cardiac and all causes, ascertained by patient report, report of medical providers, and review of medical records.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Depression</measure>
    <time_frame>2 weeks, 3 months, and 6 months</time_frame>
    <description>Patient Health Questionnaire-9 (PHQ-9)</description>
  </other_outcome>
  <other_outcome>
    <measure>Anxiety</measure>
    <time_frame>2 weeks, 3 months, and 6 months</time_frame>
    <description>Hospital Anxiety and Depression Scale Anxiety Subscale (HADS-A)</description>
  </other_outcome>
  <other_outcome>
    <measure>Health-Related Quality of Life</measure>
    <time_frame>2 weeks, 3 months, and 6 months</time_frame>
    <description>MOS Short Form-12 (SF-12)</description>
  </other_outcome>
  <other_outcome>
    <measure>Function</measure>
    <time_frame>2 weeks, 3 months, and 6 months</time_frame>
    <description>Duke Activity Symptom Index (DASI)</description>
  </other_outcome>
  <other_outcome>
    <measure>Cardiac Symptoms</measure>
    <time_frame>2 weeks, 3 months, and 6 months</time_frame>
    <description>A cardiac symptom scale adapted from the Women and Ischemia Syndrome Evaluation (WISE) study</description>
  </other_outcome>
  <other_outcome>
    <measure>Adherence to Medical Recommendations</measure>
    <time_frame>2 weeks, 3 months, and 6 months</time_frame>
    <description>The MOS Specific Adherence Scale (SAS)</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">212</enrollment>
  <condition>Myocardial Infarction</condition>
  <condition>Unstable Angina</condition>
  <arm_group>
    <arm_group_label>Enrolling by invitation</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Analyzed Blood Samples:&#xD;
&#xD;
      Subjects will have a blood draw for the following biological factors that are important to&#xD;
      cardiac health and may be modified by psychological states: Inflammation will be measured via&#xD;
      interleukin-6 (IL-6) and high sensitivity C-reactive protein (hsCRP), soluble intercellular&#xD;
      adhesion molecule-1 (sICAM-1), tumor necrosis factor alpha (TNF-α), and overall cardiac&#xD;
      prognosis will be assessed using N-terminal pro-brain natriuretic peptide (NT-proBNP). A&#xD;
      total of 15 ml/cc of blood will be drawn (this is equivalent to 3 tablespoons of blood).&#xD;
&#xD;
      Retained Blood Samples:&#xD;
&#xD;
      Given that additional, more sensitive/critical markers of cardiac outcomes may be identified&#xD;
      in the near future, participants will be given the option to allow us to store their blood&#xD;
      samples for additional biomarker analysis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the Ellison Cardiac Care Units at Massachusetts General Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients admitted to cardiac units at MGH with a primary admission diagnosis of&#xD;
             ACS (eligible patients must meet World Health Organization criteria for myocardial&#xD;
             infarction or criteria for unstable angina [new-onset angina within 2 months,&#xD;
             exacerbation of previous angina with rest pain or with minimal exercise, or angina&#xD;
             within 2 weeks of MI]). ACS diagnosis will be clarified with the inpatient care team&#xD;
             and adjudicated by co-investigator cardiologist Dr. Januzzi as needed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  'Periprocedural' ACS (ACS that occurs in the setting of another medical procedure;&#xD;
             such events may occur in the absence of structural heart disease and likely represent&#xD;
             a different pathophysiology, course and prognosis than those with 'endogenous' ACS).&#xD;
&#xD;
          -  Conditions likely to alter biomarkers of interest (renal failure requiring&#xD;
             hemodialysis, inflammatory disease [e.g., systemic lupus erythematosus])&#xD;
&#xD;
          -  Condition likely to lead to death within 6 months (e.g. cancer).&#xD;
&#xD;
          -  Inability to complete physical activity due to unrelated medical condition (e.g.,&#xD;
             severe arthritis)&#xD;
&#xD;
          -  Inability to complete self-report evaluations due to inability to speak or write in&#xD;
             English or due to cognitive deficits (assessed using an established six-item screen).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeff Huffman, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>April 28, 2015</last_update_submitted>
  <last_update_submitted_qc>April 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Jeff C. Huffman, MD</investigator_full_name>
    <investigator_title>Medical Director, Blake 11</investigator_title>
  </responsible_party>
  <keyword>acute coronary syndrome</keyword>
  <keyword>gratitude</keyword>
  <keyword>health behavior</keyword>
  <keyword>myocardial infarction</keyword>
  <keyword>unstable angina</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Angina, Unstable</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01709669
org study id: 2012P001191
nct id: NCT01709669
lead sponsor: 
collaborator: 
has dmc: No
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.
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 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.

             -  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-9,which 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
           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 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 ml/cc) 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.
observational model: Cohort
time perspective: Prospective
measure: Physical Activity
time frame: Intake and 6 months after ACS
description: 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.
measure: Biomarkers
time frame: 2 weeks and 6 months after ACS
description: Levels of inflammation (IL-6, hsCRP, sCAM-1, TNF-α) and overall cardiac prognosis (NT-proBNP)
measure: Readmissions (cardiac and all-cause)
time frame: 6 months after ACS
description: Non-elective readmissions for cardiac and all causes, ascertained by patient report, report of medical providers, and review of medical records.
measure: Depression
time frame: 2 weeks, 3 months, and 6 months
description: Patient Health Questionnaire-9 (PHQ-9)
measure: Anxiety
time frame: 2 weeks, 3 months, and 6 months
description: Hospital Anxiety and Depression Scale Anxiety Subscale (HADS-A)
measure: Health-Related Quality of Life
time frame: 2 weeks, 3 months, and 6 months
description: MOS Short Form-12 (SF-12)
measure: Function
time frame: 2 weeks, 3 months, and 6 months
description: Duke Activity Symptom Index (DASI)
measure: Cardiac Symptoms
time frame: 2 weeks, 3 months, and 6 months
description: A cardiac symptom scale adapted from the Women and Ischemia Syndrome Evaluation (WISE) study
measure: Adherence to Medical Recommendations
time frame: 2 weeks, 3 months, and 6 months
description: The MOS Specific Adherence Scale (SAS)
arm group label: Enrolling by invitation
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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeff Huffman, M.D.
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Jeff C. Huffman, MD
investigator title: Medical Director, Blake 11
mesh term: Myocardial Infarction
mesh term: Heart Diseases
mesh term: Angina, Unstable
mesh term: Infarction