<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/NCT03759873</url>
  </required_header>
  <id_info>
    <org_study_id>R61HL143305</org_study_id>
    <nct_id>NCT03759873</nct_id>
  </id_info>
  <brief_title>Incentives and Case Management to Improve Cardiac Care: Healthy Lifestyle Program</brief_title>
  <acronym>HeLP</acronym>
  <official_title>Improving Participation in Cardiac Rehabilitation Among Lower-Socioeconomic Status Patients: Efficacy of Early Case Management and Financial Incentives</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Vermont</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participation in outpatient cardiac rehabilitation (CR) decreases morbidity and mortality for&#xD;
      patients hospitalized with myocardial infarction, coronary bypass surgery or percutaneous&#xD;
      revascularization. Unfortunately, only 10-35% of patients for whom CR is indicated choose to&#xD;
      participate. Lower socioeconomic status (SES) is a robust predictor of CR non-participation.&#xD;
      There is growing recognition of the need to increase CR among economically disadvantaged&#xD;
      patients, but there are almost no evidence-based interventions available for doing so. The&#xD;
      present study will examine the efficacy of using early case management and financial&#xD;
      incentives for increasing CR participation among lower-SES patients. Case management has been&#xD;
      effective at promoting attendance at a variety of health-related programs (e.g. treatment for&#xD;
      diabetes, HIV, asthma, cocaine dependence) as well as reducing hospitalizations. Financial&#xD;
      incentives are also highly effective in altering health behaviors among disadvantaged&#xD;
      populations (e.g., smoking during pregnancy, weight loss) including CR participation in a&#xD;
      prior trial. For this study 209 CR-eligible lower-SES patients will be randomized to: a&#xD;
      treatment condition where patients are assigned a case manager while in hospital who will&#xD;
      facilitate CR attendance and coordinate cardiac care, a treatment condition where patients&#xD;
      receive financial incentives contingent on initiation of and continued attendance at CR&#xD;
      sessions, a combination of these two interventions, or to a &quot;usual-care&quot; condition.&#xD;
      Participants in all conditions will complete pre- and post-treatment assessments. Treatment&#xD;
      conditions will be compared on attendance at CR and end-of-intervention improvements in&#xD;
      fitness, executive function, and health-related quality of life. Cost effectiveness of the&#xD;
      treatment conditions will also be examined by comparing the costs of delivering the&#xD;
      interventions and the usual care condition, taking into account increases in CR&#xD;
      participation. Furthermore, the value of the interventions will be modeled based on increases&#xD;
      in participation rates, intervention costs, long-term medical costs, and health outcomes&#xD;
      after a coronary event. This systematic examination of promising interventions will allow&#xD;
      testing of the efficacy and cost-effectiveness of approaches that have the potential to&#xD;
      substantially increase CR participation and significantly improve health outcomes among&#xD;
      lower-SES cardiac patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Actual">May 1, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac Rehabilitation Attendance</measure>
    <time_frame>Within 4 months of the intake assessment</time_frame>
    <description>Number of cardiac rehabilitation sessions completed out of a possible 36</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiac Rehabilitation Completion</measure>
    <time_frame>Within 4 months of the intake assessment</time_frame>
    <description>Proportion of patients who complete 30+ sessions of cardiac rehabilitation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in fitness</measure>
    <time_frame>Within 4 months of the intake assessment</time_frame>
    <description>Changes in fitness level (peak oxygen uptake or METS as appropriate) will be measured from intake to completion of the intervention (4 months after intake).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body composition</measure>
    <time_frame>Within 4 months of the intake assessment</time_frame>
    <description>Changes in waist measurement will be measured from intake to completion of the intervention (4 months after intake).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in smoking status</measure>
    <time_frame>Within 4 months of the intake assessment</time_frame>
    <description>Changes in smoking status will be measured from intake to completion of the intervention (4 months after intake).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life - cardiac specific</measure>
    <time_frame>Within 4 months of the intake assessment</time_frame>
    <description>Changes in perceived quality of life (MacNew) questionnaires will be measured from intake to completion of the intervention (4 months after intake).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life - non-specific</measure>
    <time_frame>Within 4 months of the intake assessment</time_frame>
    <description>Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intake to completion of the intervention (4 months after intake).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in mental health</measure>
    <time_frame>Within 4 months of the intake assessment</time_frame>
    <description>Changes in mental health (Adult Self-Report) questionnaires will be measured from intake to completion of the intervention (4 months after intake).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in depressive symptoms</measure>
    <time_frame>Within 4 months of the intake assessment</time_frame>
    <description>Changes in reported depressive symptoms &quot;The Beck Depression Inventory (BDI)&quot; will be measured from intake to completion of the intervention (4 months after intake).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Executive Function (DD)</measure>
    <time_frame>Within 4 months of the intake assessment</time_frame>
    <description>Changes in Executive function (delay discounting) will be measured from intake to completion of the intervention (4 months after intake).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Executive Function (DS)</measure>
    <time_frame>Within 4 months of the intake assessment</time_frame>
    <description>Changes in Executive function (digit span) will be measured from intake to completion of the intervention (4 months after intake).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Executive Function (Trail)</measure>
    <time_frame>Within 4 months of the intake assessment</time_frame>
    <description>Changes in Executive function (Trail making task) will be measured from intake to completion of the intervention (4 months after intake).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Executive Function (BRIEF)</measure>
    <time_frame>Within 4 months of the intake assessment</time_frame>
    <description>Changes in self-reported Executive function problems (BRIEF) will be measured from intake to completion of the intervention (4 months after intake).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Executive Function (SST)</measure>
    <time_frame>Within 4 months of the intake assessment</time_frame>
    <description>Changes in Executive function (Stop Signal Task) will be measured from intake to completion of the intervention (4 months after intake).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care contacts</measure>
    <time_frame>One year period starting at intake assessment.</time_frame>
    <description>Combined measure of number of Emergency Department (ED) visits and overnight hospitalizations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care costs</measure>
    <time_frame>One year period starting at intake assessment.</time_frame>
    <description>Costs associated with combined Emergency Department (ED) visits and overnight hospitalizations.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Maintenance of fitness following intervention.</measure>
    <time_frame>From completion of intervention (4 months) to follow-up (one-year).</time_frame>
    <description>Changes in fitness level (peak oxygen uptake or METS as appropriate) will be measured from intervention completion until follow-up (8 months after intervention completion).</description>
  </other_outcome>
  <other_outcome>
    <measure>Maintenance of waist circumference following intervention.</measure>
    <time_frame>From completion of intervention (4 months) to follow-up (one-year).</time_frame>
    <description>Changes in waist circumference will be measured from intervention completion until follow-up (8 months after intervention completion).</description>
  </other_outcome>
  <other_outcome>
    <measure>Maintenance of smoking status following intervention.</measure>
    <time_frame>From completion of intervention (4 months) to follow-up (one-year).</time_frame>
    <description>Changes in smoking status will be measured from intervention completion until follow-up (8 months after intervention completion).</description>
  </other_outcome>
  <other_outcome>
    <measure>Maintenance of quality of life (cardiac-specific) following intervention.</measure>
    <time_frame>From completion of intervention (4 months) to follow-up (one-year).</time_frame>
    <description>Changes in QoL(MacNew) will be measured from intervention completion until follow-up (8 months after intervention completion).</description>
  </other_outcome>
  <other_outcome>
    <measure>Maintenance of quality of life (noncardiac-specific) following intervention.</measure>
    <time_frame>From completion of intervention (4 months) to follow-up (one-year).</time_frame>
    <description>Changes in QoL (EuroQol) will be measured from intervention completion until follow-up (8 months after intervention completion).</description>
  </other_outcome>
  <other_outcome>
    <measure>Maintenance of mental health following intervention.</measure>
    <time_frame>From completion of intervention (4 months) to follow-up (one-year).</time_frame>
    <description>Changes in mental health (Adult Self-Report) will be measured from intervention completion until follow-up (8 months after intervention completion).</description>
  </other_outcome>
  <other_outcome>
    <measure>Maintenance of depressive symptoms following intervention.</measure>
    <time_frame>From completion of intervention (4 months) to follow-up (one-year).</time_frame>
    <description>Changes in depressive symptoms (BDI) will be measured from intervention completion until follow-up (8 months after intervention completion).</description>
  </other_outcome>
  <other_outcome>
    <measure>Maintenance of Executive Function (DD) following intervention.</measure>
    <time_frame>From completion of intervention (4 months) to follow-up (one-year).</time_frame>
    <description>Changes in Executive function (delay discounting) will be measured from intervention completion until follow-up (8 months after intervention completion).</description>
  </other_outcome>
  <other_outcome>
    <measure>Maintenance of Executive Function (DS) following intervention.</measure>
    <time_frame>From completion of intervention (4 months) to follow-up (one-year).</time_frame>
    <description>Changes in Executive function (digit span) will be measured from intervention completion until follow-up (8 months after intervention completion).</description>
  </other_outcome>
  <other_outcome>
    <measure>Maintenance of Executive Function (BRIEF) following intervention.</measure>
    <time_frame>From completion of intervention (4 months) to follow-up (one-year).</time_frame>
    <description>Changes in self-reported Executive function problems (BRIEF) will be measured from intervention completion until follow-up (8 months after intervention completion).</description>
  </other_outcome>
  <other_outcome>
    <measure>Maintenance of Executive Function (SST) following intervention.</measure>
    <time_frame>From completion of intervention (4 months) to follow-up (one-year).</time_frame>
    <description>Changes in Executive function (stop signal task) will be measured from intervention completion until follow-up (8 months after intervention completion).</description>
  </other_outcome>
  <other_outcome>
    <measure>Maintenance of Executive Function (Trail) following intervention.</measure>
    <time_frame>From completion of intervention (4 months) to follow-up (one-year).</time_frame>
    <description>Changes in Executive function (trail making task) will be measured from intervention completion until follow-up (8 months after intervention completion).</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>One year period starting at intake assessment.</time_frame>
    <description>Cost-effectiveness of the intervention will be determined. Cost-effectiveness is a single outcome (cost per per quality-adjusted life year gained) that is calculated by integrating the cost of delivering the intervention, the cost to the patient of receiving the intervention, and the benefits both in quality of life and in reductions in healthcare utilization.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">209</enrollment>
  <condition>Cardiac Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Incentives</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient earns incentives for completing cardiac rehabilitation sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Case Management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient is assigned a case manager while in hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Incentives and Case Management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient receives both the Incentives and Case Management interventions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This control condition does not receive either intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Incentives</intervention_name>
    <description>Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.</description>
    <arm_group_label>Incentives</arm_group_label>
    <arm_group_label>Incentives and Case Management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Case Management</intervention_name>
    <description>A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.</description>
    <arm_group_label>Case Management</arm_group_label>
    <arm_group_label>Incentives and Case Management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A recent myocardial infarction, coronary revascularization, diagnosis of congestive&#xD;
             heart failure (CHF) or heart valve replacement or repair&#xD;
&#xD;
          -  Enrolled in a state-supported insurance plan for low income individuals or receiving&#xD;
             other state benefits that are based on financial need (housing subsidy, food stamps,&#xD;
             etc.), or with a less than high school education.&#xD;
&#xD;
          -  Lives in and plans to remain in the greater Burlington, Vermont area (Chittenden&#xD;
             county) for the next 12 mos.&#xD;
&#xD;
          -  Copley Hospital (Morrisville, VT) transfer patient (enrolled in a state-supported&#xD;
             insurance plan for low income individuals or receiving other state benefits that are&#xD;
             based on financial need)&#xD;
&#xD;
          -  Northwestern Medical Center (St Albans, VT) transfer patient (enrolled in a&#xD;
             state-supported insurance plan for low income individuals or receiving other state&#xD;
             benefits that are based on financial need)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia (MMSE&lt;20) or current untreated Axis 1 psychiatric disorder other than&#xD;
             nicotine dependence as determined by medical history&#xD;
&#xD;
          -  Advanced cancer, advanced frailty, or other longevity-limiting systemic disease that&#xD;
             would preclude CR participation&#xD;
&#xD;
          -  Rest angina or very low threshold angina (&lt;2 METS) until adequate therapy is&#xD;
             instituted&#xD;
&#xD;
          -  Severe life threatening ventricular arrhythmias unless adequately controlled (e.g.&#xD;
             intracardiac defibrillator)&#xD;
&#xD;
          -  Class 4 chronic heart failure (symptoms at rest)&#xD;
&#xD;
          -  Exercise-limiting non-cardiac disease such as severe arthritis, past stroke, severe&#xD;
             lung disease&#xD;
&#xD;
          -  Previous successful attendance at cardiac rehabilitation (defined as completing 6+&#xD;
             sessions in the past 10 years)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Vermont Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>May 12, 2023</last_update_submitted>
  <last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vermont</investigator_affiliation>
    <investigator_full_name>Diann Gaalema</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Incentives</keyword>
  <keyword>Case management</keyword>
  <keyword>Socioeconomic status</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 8, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03759873/Prot_SAP_004.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 16, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03759873/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03759873
org study id: R61HL143305
nct id: NCT03759873
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Participation in outpatient cardiac rehabilitation (CR) decreases morbidity and mortality for
      patients hospitalized with myocardial infarction, coronary bypass surgery or percutaneous
      revascularization. Unfortunately, only 10-35% of patients for whom CR is indicated choose to
      participate. Lower socioeconomic status (SES) is a robust predictor of CR non-participation.
      There is growing recognition of the need to increase CR among economically disadvantaged
      patients, but there are almost no evidence-based interventions available for doing so. The
      present study will examine the efficacy of using early case management and financial
      incentives for increasing CR participation among lower-SES patients. Case management has been
      effective at promoting attendance at a variety of health-related programs (e.g. treatment for
      diabetes, HIV, asthma, cocaine dependence) as well as reducing hospitalizations. Financial
      incentives are also highly effective in altering health behaviors among disadvantaged
      populations (e.g., smoking during pregnancy, weight loss) including CR participation in a
      prior trial. For this study 209 CR-eligible lower-SES patients will be randomized to: a
      treatment condition where patients are assigned a case manager while in hospital who will
      facilitate CR attendance and coordinate cardiac care, a treatment condition where patients
      receive financial incentives contingent on initiation of and continued attendance at CR
      sessions, a combination of these two interventions, or to a "usual-care" condition.
      Participants in all conditions will complete pre- and post-treatment assessments. Treatment
      conditions will be compared on attendance at CR and end-of-intervention improvements in
      fitness, executive function, and health-related quality of life. Cost effectiveness of the
      treatment conditions will also be examined by comparing the costs of delivering the
      interventions and the usual care condition, taking into account increases in CR
      participation. Furthermore, the value of the interventions will be modeled based on increases
      in participation rates, intervention costs, long-term medical costs, and health outcomes
      after a coronary event. This systematic examination of promising interventions will allow
      testing of the efficacy and cost-effectiveness of approaches that have the potential to
      substantially increase CR participation and significantly improve health outcomes among
      lower-SES cardiac patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Cardiac Rehabilitation Attendance
time frame: Within 4 months of the intake assessment
description: Number of cardiac rehabilitation sessions completed out of a possible 36
measure: Cardiac Rehabilitation Completion
time frame: Within 4 months of the intake assessment
description: Proportion of patients who complete 30+ sessions of cardiac rehabilitation
measure: Change in fitness
time frame: Within 4 months of the intake assessment
description: Changes in fitness level (peak oxygen uptake or METS as appropriate) will be measured from intake to completion of the intervention (4 months after intake).
measure: Change in body composition
time frame: Within 4 months of the intake assessment
description: Changes in waist measurement will be measured from intake to completion of the intervention (4 months after intake).
measure: Changes in smoking status
time frame: Within 4 months of the intake assessment
description: Changes in smoking status will be measured from intake to completion of the intervention (4 months after intake).
measure: Changes in quality of life - cardiac specific
time frame: Within 4 months of the intake assessment
description: Changes in perceived quality of life (MacNew) questionnaires will be measured from intake to completion of the intervention (4 months after intake).
measure: Changes in quality of life - non-specific
time frame: Within 4 months of the intake assessment
description: Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intake to completion of the intervention (4 months after intake).
measure: Changes in mental health
time frame: Within 4 months of the intake assessment
description: Changes in mental health (Adult Self-Report) questionnaires will be measured from intake to completion of the intervention (4 months after intake).
measure: Changes in depressive symptoms
time frame: Within 4 months of the intake assessment
description: Changes in reported depressive symptoms "The Beck Depression Inventory (BDI)" will be measured from intake to completion of the intervention (4 months after intake).
measure: Changes in Executive Function (DD)
time frame: Within 4 months of the intake assessment
description: Changes in Executive function (delay discounting) will be measured from intake to completion of the intervention (4 months after intake).
measure: Changes in Executive Function (DS)
time frame: Within 4 months of the intake assessment
description: Changes in Executive function (digit span) will be measured from intake to completion of the intervention (4 months after intake).
measure: Changes in Executive Function (Trail)
time frame: Within 4 months of the intake assessment
description: Changes in Executive function (Trail making task) will be measured from intake to completion of the intervention (4 months after intake).
measure: Changes in Executive Function (BRIEF)
time frame: Within 4 months of the intake assessment
description: Changes in self-reported Executive function problems (BRIEF) will be measured from intake to completion of the intervention (4 months after intake).
measure: Changes in Executive Function (SST)
time frame: Within 4 months of the intake assessment
description: Changes in Executive function (Stop Signal Task) will be measured from intake to completion of the intervention (4 months after intake).
measure: Health care contacts
time frame: One year period starting at intake assessment.
description: Combined measure of number of Emergency Department (ED) visits and overnight hospitalizations.
measure: Health care costs
time frame: One year period starting at intake assessment.
description: Costs associated with combined Emergency Department (ED) visits and overnight hospitalizations.
measure: Maintenance of fitness following intervention.
time frame: From completion of intervention (4 months) to follow-up (one-year).
description: Changes in fitness level (peak oxygen uptake or METS as appropriate) will be measured from intervention completion until follow-up (8 months after intervention completion).
measure: Maintenance of waist circumference following intervention.
time frame: From completion of intervention (4 months) to follow-up (one-year).
description: Changes in waist circumference will be measured from intervention completion until follow-up (8 months after intervention completion).
measure: Maintenance of smoking status following intervention.
time frame: From completion of intervention (4 months) to follow-up (one-year).
description: Changes in smoking status will be measured from intervention completion until follow-up (8 months after intervention completion).
measure: Maintenance of quality of life (cardiac-specific) following intervention.
time frame: From completion of intervention (4 months) to follow-up (one-year).
description: Changes in QoL(MacNew) will be measured from intervention completion until follow-up (8 months after intervention completion).
measure: Maintenance of quality of life (noncardiac-specific) following intervention.
time frame: From completion of intervention (4 months) to follow-up (one-year).
description: Changes in QoL (EuroQol) will be measured from intervention completion until follow-up (8 months after intervention completion).
measure: Maintenance of mental health following intervention.
time frame: From completion of intervention (4 months) to follow-up (one-year).
description: Changes in mental health (Adult Self-Report) will be measured from intervention completion until follow-up (8 months after intervention completion).
measure: Maintenance of depressive symptoms following intervention.
time frame: From completion of intervention (4 months) to follow-up (one-year).
description: Changes in depressive symptoms (BDI) will be measured from intervention completion until follow-up (8 months after intervention completion).
measure: Maintenance of Executive Function (DD) following intervention.
time frame: From completion of intervention (4 months) to follow-up (one-year).
description: Changes in Executive function (delay discounting) will be measured from intervention completion until follow-up (8 months after intervention completion).
measure: Maintenance of Executive Function (DS) following intervention.
time frame: From completion of intervention (4 months) to follow-up (one-year).
description: Changes in Executive function (digit span) will be measured from intervention completion until follow-up (8 months after intervention completion).
measure: Maintenance of Executive Function (BRIEF) following intervention.
time frame: From completion of intervention (4 months) to follow-up (one-year).
description: Changes in self-reported Executive function problems (BRIEF) will be measured from intervention completion until follow-up (8 months after intervention completion).
measure: Maintenance of Executive Function (SST) following intervention.
time frame: From completion of intervention (4 months) to follow-up (one-year).
description: Changes in Executive function (stop signal task) will be measured from intervention completion until follow-up (8 months after intervention completion).
measure: Maintenance of Executive Function (Trail) following intervention.
time frame: From completion of intervention (4 months) to follow-up (one-year).
description: Changes in Executive function (trail making task) will be measured from intervention completion until follow-up (8 months after intervention completion).
measure: Cost-effectiveness
time frame: One year period starting at intake assessment.
description: Cost-effectiveness of the intervention will be determined. Cost-effectiveness is a single outcome (cost per per quality-adjusted life year gained) that is calculated by integrating the cost of delivering the intervention, the cost to the patient of receiving the intervention, and the benefits both in quality of life and in reductions in healthcare utilization.
arm group label: Incentives
arm group type: Experimental
description: Patient earns incentives for completing cardiac rehabilitation sessions.
arm group label: Case Management
arm group type: Experimental
description: Patient is assigned a case manager while in hospital.
arm group label: Incentives and Case Management
arm group type: Experimental
description: Patient receives both the Incentives and Case Management interventions.
arm group label: Usual care
arm group type: No Intervention
description: This control condition does not receive either intervention.
intervention type: Behavioral
intervention name: Incentives
description: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.
arm group label: Incentives
arm group label: Incentives and Case Management
intervention type: Behavioral
intervention name: Case Management
description: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.
arm group label: Case Management
arm group label: Incentives and Case Management
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Vermont
investigator full name: Diann Gaalema
investigator title: Assistant Professor
sharing ipd: No
provided document: 
provided document: 