<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/NCT03834155</url>
  </required_header>
  <id_info>
    <org_study_id>18-1290</org_study_id>
    <nct_id>NCT03834155</nct_id>
  </id_info>
  <brief_title>Enhancing Cardiac Rehabilitation Through Behavioral Nudges</brief_title>
  <official_title>Enhancing Cardiac Rehabilitation Adherence Through Home-based Rehabilitation and Behavioral Nudges: ERA Nudge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Denver Health and Hospital Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Denver Health and Hospital Authority</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>
      Adherence to cardiac rehabilitation is poor, and worse for minorities, women, and those with&#xD;
      lower levels of education. Patients less likely to be referred to and complete cardiac rehab&#xD;
      are at highest risk of adverse outcomes and thus have the most to gain from participation in&#xD;
      cardiac rehab. To improve participation, healthcare systems need to limit barriers to&#xD;
      enrollment and promote adherence to rehabilitation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to (1) iteratively develop and program a theoretically informed&#xD;
      technology-based nudge message library for a diverse patient population using multiple and&#xD;
      iterative N of 1 within subject studies. Investigators will also engage patient, provider and&#xD;
      health systems stakeholders in designing and refining the messages. (2)Develop a one-page&#xD;
      decision aid tool to present information designed with principles of shared decision making&#xD;
      including pros and cons of hospital and home-based rehabilitation. Investigators will engage&#xD;
      patients, providers, and health systems stakeholders to provide feedback on the information&#xD;
      sheet. (3) Conduct a 2x2 factorial design randomized trial of a) choice and b) nudge&#xD;
      messaging to improve primary outcome of CR adherence. Secondary outcomes will include&#xD;
      enrollment and completion of CR, exercise capacity, patient engagement, quality of life,&#xD;
      hospitalizations, and healthcare utilization. The study will additionally evaluate the&#xD;
      interventions using a mixed methods approach applying the RE-AIM (reach, effectiveness,&#xD;
      adoption, implementation, and maintenance) framework and a cost-effectiveness analysis. The&#xD;
      cost-effectiveness analysis sub-study will evaluate the implementation cost of home-based and&#xD;
      hospital-based cardiac rehabilitation programs in addition to the incremental cost&#xD;
      effectiveness ratios for each intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2023</primary_completion_date>
  <phase>N/A</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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will be randomized to hospital-based cardiovascular rehabilitation (CR), or choice of hospital-based or home-based CR. All participants will also have access to the the application. Participants will be randomized to either application only or application + NUDGE messaging.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to cardiovascular rehabilitation measured by self-report in the Movn Application or through EHR/exercise physiologist report in RedCap</measure>
    <time_frame>12 weeks</time_frame>
    <description>Attendance for 4 weeks (8 or more) exercise sessions for hospital-based CR or logging exercise data for 4 weeks for home-based rehabilitation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Active enrollment of 280 DH participants</measure>
    <time_frame>3.5 yrs</time_frame>
    <description>Attending one visit following baseline visit or logging exercise data at least once for home-based CR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completion of cardiovascular rehabilitation as defined by attending or logging 18 exercise sessions</measure>
    <time_frame>12 weeks</time_frame>
    <description>Attending or logging 18 exercise sessions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise capacity measured by a 6-minute walk test.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Exercise capacity will be measured at the index visit, 6 weeks, 12 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient activation and engagement will be measured using the 13-item Patient Activation Measure (PAM)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The low-literacy version of the 13-item Patient Activation Measure (PAM), both in English and Spanish, will be used to assess the effect of the intervention on patient activation. This validated and predictive tool assesses patient knowledge, skill and confidence in self-management. A single point change in PAM score is clinically meaningful and increases in the PAM are associated with increased self-management behavior. The PAM will be measured at the index visit, 6 weeks, 12 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reported quality of life measured by Ferrans and Powers Quality of Life Index</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Ferrans and Powers Quality of Life Index (QLI) will be used to assess quality of life. The QLI is a 35 question instrument that uses a 6 point scale ranging from &quot;very unimportant (lower end of the scale)&quot; to &quot;very important (higher end of the scale)&quot;. The outcomes of these scales are averaged to compute the total score. The QLI is valid, reliable, sensitive to change in both CR and PR populations, and is available in English and in Spanish. The QLI will be administered at the index visit, 6 weeks and 12 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants hospitalized over four months using EHR review and ICD-10s</measure>
    <time_frame>6 months</time_frame>
    <description>All-cause hospitalizations will be ascertained via the EHR using ICD-10 codes. Follow-up for hospitalizations will occur through 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who attend or log of 36 cardiovascular rehabilitation sessions measured by self-report in the Movn Application or through EHR/exercise physiologist report in RedCap</measure>
    <time_frame>12 weeks</time_frame>
    <description>Attending or logging 36 exercise sessions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of healthcare utilization by individual participants, defined by routine clinical visits. Urgent care and emergency department visits will be measured using EHR.</measure>
    <time_frame>6 months</time_frame>
    <description>Healthcare utilization, defined by routine clinical visits. Urgent care and emergency department visits will be measured using EHR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety measures to track injury from exercise will be assessed using EHR</measure>
    <time_frame>12 weeks</time_frame>
    <description>Injury from exercise will be assessed using EHR including hospitalizations, emergency department visits, urgent care visits and mortality safety endpoints.&#xD;
They will be captured at the time of occurrence and records will be reviewed by the DSMB.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Socioeconomic and clinical data will be collected from EHR.</measure>
    <time_frame>3.5 yrs</time_frame>
    <description>Sociodemographic and clinical data will be collected from DH registration files including age, gender, self-reported race/ethnicity, primary language preference, comorbid diagnoses (hypertension, diabetes, chronic kidney disease, depression, substance abuse), measures of disease severity (left ventricular ejection fraction, FEV1) and medications.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Valvular Disease</condition>
  <condition>Chronic Stable Angina</condition>
  <condition>Chronic Stable Heart Failure</condition>
  <arm_group>
    <arm_group_label>Hospital-based CR + Mobile Application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Traditional hospital-based cardiac rehabilitation with mobile application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Choice CR + Mobile Application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Choice of hospital or home-based cardiac rehabilitation with mobile application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hospital-based CR + Mobile Application + Nudge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hospital-based cardiac rehabilitation with mobile application and nudges.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Choice CR + Mobile Application + Nudges</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Choice of Hospital or home-based cardiac rehabilitation with mobile application and nudges.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hospital-based CR + Movn Application</intervention_name>
    <description>Participants will be randomly assigned to a group that will receive hospital-based CR and access to the Movn mobile application.</description>
    <arm_group_label>Hospital-based CR + Mobile Application</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Choice of Hospital or home-based CR + Movn Application</intervention_name>
    <description>Participants will be randomly assigned to a group that has opportunity to opt in to hospital-based cardiovascular rehabilitation or home-based cardiovascular rehabilitation. All will have access to the Movn Application.</description>
    <arm_group_label>Choice CR + Mobile Application</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hospital-based CR + Movn Application + Nudge</intervention_name>
    <description>Participants will be randomly assigned to a group that will receive hospital-based CR and access to the Movn mobile application, plus encouraging nudge messages.</description>
    <arm_group_label>Hospital-based CR + Mobile Application + Nudge</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Choice of Hospital or home-based CR + Movn Application + Nudge</intervention_name>
    <description>Participants will be randomly assigned to a group that has opportunity to opt in to hospital-based cardiovascular rehabilitation or home-based cardiovascular rehabilitation. All will have access to the Movn Application, plus encouraging nudge messages.</description>
    <arm_group_label>Choice CR + Mobile Application + Nudges</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of acute myocardial infarction, percutaneous coronary intervention, coronary&#xD;
             artery bypass graft, valvular heart surgery, chronic stable angina, and/or chronic&#xD;
             stable heart failure with left ventricular systolic dysfunction.&#xD;
&#xD;
          -  18 year of age or older&#xD;
&#xD;
          -  Access to a cell phone with text messaging capability&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical director's decision based on high-risk assessment&#xD;
&#xD;
          -  Enrolled in hospice or palliative care&#xD;
&#xD;
          -  Being intoxicated or otherwise unable to consent to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pamela Peterson, MD, MSPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Denver Health and Hospital Authority</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kevin H Andresen, MPH</last_name>
    <phone>303-602-4859</phone>
    <email>kevin.andresen@dhha.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pamela Peterson, MD, MSPH</last_name>
    <email>pamela.peterson@ucdenver.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Denver Health and Hospital Authority</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kevin H Andresen, MPH</last_name>
      <phone>303-602-4859</phone>
      <email>kevin.andresen@dhha.org</email>
    </contact>
    <contact_backup>
      <last_name>Pamela Peterson, MD, MPH</last_name>
      <email>pamela.peterson@dhha.org</email>
    </contact_backup>
    <investigator>
      <last_name>Pamela Peterson, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>August 12, 2021</last_update_submitted>
  <last_update_submitted_qc>August 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Angina, Stable</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03834155
org study id: 18-1290
nct id: NCT03834155
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Adherence to cardiac rehabilitation is poor, and worse for minorities, women, and those with
      lower levels of education. Patients less likely to be referred to and complete cardiac rehab
      are at highest risk of adverse outcomes and thus have the most to gain from participation in
      cardiac rehab. To improve participation, healthcare systems need to limit barriers to
      enrollment and promote adherence to rehabilitation.
This study aims to (1) iteratively develop and program a theoretically informed
      technology-based nudge message library for a diverse patient population using multiple and
      iterative N of 1 within subject studies. Investigators will also engage patient, provider and
      health systems stakeholders in designing and refining the messages. (2)Develop a one-page
      decision aid tool to present information designed with principles of shared decision making
      including pros and cons of hospital and home-based rehabilitation. Investigators will engage
      patients, providers, and health systems stakeholders to provide feedback on the information
      sheet. (3) Conduct a 2x2 factorial design randomized trial of a) choice and b) nudge
      messaging to improve primary outcome of CR adherence. Secondary outcomes will include
      enrollment and completion of CR, exercise capacity, patient engagement, quality of life,
      hospitalizations, and healthcare utilization. The study will additionally evaluate the
      interventions using a mixed methods approach applying the RE-AIM (reach, effectiveness,
      adoption, implementation, and maintenance) framework and a cost-effectiveness analysis. The
      cost-effectiveness analysis sub-study will evaluate the implementation cost of home-based and
      hospital-based cardiac rehabilitation programs in addition to the incremental cost
      effectiveness ratios for each intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
masking description: Participants will be randomized to hospital-based cardiovascular rehabilitation (CR), or choice of hospital-based or home-based CR. All participants will also have access to the the application. Participants will be randomized to either application only or application + NUDGE messaging.
measure: Adherence to cardiovascular rehabilitation measured by self-report in the Movn Application or through EHR/exercise physiologist report in RedCap
time frame: 12 weeks
description: Attendance for 4 weeks (8 or more) exercise sessions for hospital-based CR or logging exercise data for 4 weeks for home-based rehabilitation.
measure: Active enrollment of 280 DH participants
time frame: 3.5 yrs
description: Attending one visit following baseline visit or logging exercise data at least once for home-based CR.
measure: Completion of cardiovascular rehabilitation as defined by attending or logging 18 exercise sessions
time frame: 12 weeks
description: Attending or logging 18 exercise sessions
measure: Exercise capacity measured by a 6-minute walk test.
time frame: 12 weeks
description: Exercise capacity will be measured at the index visit, 6 weeks, 12 weeks.
measure: Patient activation and engagement will be measured using the 13-item Patient Activation Measure (PAM)
time frame: 12 weeks
description: The low-literacy version of the 13-item Patient Activation Measure (PAM), both in English and Spanish, will be used to assess the effect of the intervention on patient activation. This validated and predictive tool assesses patient knowledge, skill and confidence in self-management. A single point change in PAM score is clinically meaningful and increases in the PAM are associated with increased self-management behavior. The PAM will be measured at the index visit, 6 weeks, 12 weeks.
measure: Reported quality of life measured by Ferrans and Powers Quality of Life Index
time frame: 12 weeks
description: The Ferrans and Powers Quality of Life Index (QLI) will be used to assess quality of life. The QLI is a 35 question instrument that uses a 6 point scale ranging from "very unimportant (lower end of the scale)" to "very important (higher end of the scale)". The outcomes of these scales are averaged to compute the total score. The QLI is valid, reliable, sensitive to change in both CR and PR populations, and is available in English and in Spanish. The QLI will be administered at the index visit, 6 weeks and 12 weeks.
measure: Number of participants hospitalized over four months using EHR review and ICD-10s
time frame: 6 months
description: All-cause hospitalizations will be ascertained via the EHR using ICD-10 codes. Follow-up for hospitalizations will occur through 6 months.
measure: Number of participants who attend or log of 36 cardiovascular rehabilitation sessions measured by self-report in the Movn Application or through EHR/exercise physiologist report in RedCap
time frame: 12 weeks
description: Attending or logging 36 exercise sessions.
measure: Type of healthcare utilization by individual participants, defined by routine clinical visits. Urgent care and emergency department visits will be measured using EHR.
time frame: 6 months
description: Healthcare utilization, defined by routine clinical visits. Urgent care and emergency department visits will be measured using EHR.
measure: Safety measures to track injury from exercise will be assessed using EHR
time frame: 12 weeks
description: Injury from exercise will be assessed using EHR including hospitalizations, emergency department visits, urgent care visits and mortality safety endpoints.
They will be captured at the time of occurrence and records will be reviewed by the DSMB.
measure: Socioeconomic and clinical data will be collected from EHR.
time frame: 3.5 yrs
description: Sociodemographic and clinical data will be collected from DH registration files including age, gender, self-reported race/ethnicity, primary language preference, comorbid diagnoses (hypertension, diabetes, chronic kidney disease, depression, substance abuse), measures of disease severity (left ventricular ejection fraction, FEV1) and medications.
arm group label: Hospital-based CR + Mobile Application
arm group type: Experimental
description: Traditional hospital-based cardiac rehabilitation with mobile application.
arm group label: Choice CR + Mobile Application
arm group type: Experimental
description: Choice of hospital or home-based cardiac rehabilitation with mobile application.
arm group label: Hospital-based CR + Mobile Application + Nudge
arm group type: Experimental
description: Hospital-based cardiac rehabilitation with mobile application and nudges.
arm group label: Choice CR + Mobile Application + Nudges
arm group type: Experimental
description: Choice of Hospital or home-based cardiac rehabilitation with mobile application and nudges.
intervention type: Other
intervention name: Hospital-based CR + Movn Application
description: Participants will be randomly assigned to a group that will receive hospital-based CR and access to the Movn mobile application.
arm group label: Hospital-based CR + Mobile Application
intervention type: Other
intervention name: Choice of Hospital or home-based CR + Movn Application
description: Participants will be randomly assigned to a group that has opportunity to opt in to hospital-based cardiovascular rehabilitation or home-based cardiovascular rehabilitation. All will have access to the Movn Application.
arm group label: Choice CR + Mobile Application
intervention type: Other
intervention name: Hospital-based CR + Movn Application + Nudge
description: Participants will be randomly assigned to a group that will receive hospital-based CR and access to the Movn mobile application, plus encouraging nudge messages.
arm group label: Hospital-based CR + Mobile Application + Nudge
intervention type: Other
intervention name: Choice of Hospital or home-based CR + Movn Application + Nudge
description: Participants will be randomly assigned to a group that has opportunity to opt in to hospital-based cardiovascular rehabilitation or home-based cardiovascular rehabilitation. All will have access to the Movn Application, plus encouraging nudge messages.
arm group label: Choice CR + Mobile Application + Nudges
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Pamela Peterson, MD, MSPH
role: Principal Investigator
affiliation: Denver Health and Hospital Authority
last name: Kevin H Andresen, MPH
phone: 303-602-4859
email: kevin.andresen@dhha.org
last name: Pamela Peterson, MD, MSPH
email: pamela.peterson@ucdenver.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Infarction
mesh term: Angina, Stable
mesh term: Infarction
sharing ipd: No