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Trial record 1 of 1 for:    Pamela Peterson | cardiac rehab | Colorado, United States
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Enhancing Cardiac Rehabilitation Through Behavioral Nudges

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ClinicalTrials.gov Identifier: NCT03834155
Recruitment Status : Not yet recruiting
First Posted : February 7, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Denver Health and Hospital Authority

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Percutaneous Coronary Intervention Coronary Artery Disease Valvular Disease Chronic Stable Angina Chronic Stable Heart Failure Other: Hospital-based CR + Movn Application Other: Choice of Hospital or home-based CR + Movn Application Other: Hospital-based CR + Movn Application + Nudge Other: Choice of Hospital or home-based CR + Movn Application + Nudge Not Applicable

Detailed Description:
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.Evaluate the intervention using a mixed methods approach and applying the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Health Services Research
Official Title: Enhancing Cardiac Rehabilitation Adherence Through Home-based Rehabilitation and Behavioral Nudges: ERA Nudge
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hospital-based CR + Movn Application
Hospital-based CR +mobile application
Other: Hospital-based CR + Movn Application
Participants will be randomly assigned to a group that will receive hospital-based CR and access to the Movn mobile application

Experimental: Choice CR + mobile application
Choice of hospital or home-based CR + Movn Application
Other: Choice of Hospital or home-based CR + Movn Application
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

Experimental: Hospital-based CR + Movn Application +Nudge
Hospital-based CR + mobile application and nudges
Other: Hospital-based CR + Movn Application + Nudge
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

Experimental: Choice CR + mobile application and nudges
Choice of Hospital or home-based CR + Movn Application + Nudge
Other: Choice of Hospital or home-based CR + Movn Application + Nudge
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




Primary Outcome Measures :
  1. Adherence to cardiovascular rehabilitation measured by self-report in the Movn Application or through EHR/exercise physiologist report in RedCap [ Time Frame: 3.5 yrs ]
    Attendance for 4 weeks (8 or more) exercise sessions) for hospital-based CR or logging exercise data for 4 weeks for home-based rehabilitation.


Secondary Outcome Measures :
  1. Active enrollment of 280 DH participants [ Time Frame: 3.5 yrs ]
    Attending one visit following baseline visit or logging exercise data at least once for home-based CR.

  2. Completion of cardiovascular rehabilitation as defined by attending or logging 18 exercise sessions [ Time Frame: 3.5 yrs ]
    Attending or logging 18 exercise sessions

  3. Exercise duration measured by a 6-minute walk using METS achieved on a treadmill test using the Ramp Bruce protocol [ Time Frame: 12 weeks ]
    Exercise capacity will be measured at the index visit, 6 weeks, 12 weeks.

  4. Patient activation and engagement will be measured using the 13-item Patient Activation Measure (PAM) [ Time Frame: 12 weeks ]
    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.68 The PAM will be measured at the index visit, 6 weeks, 12 weeks.

  5. Reported quality of life measured by Ferrans and Powers Quality of Life Index [ Time Frame: 12 weeks ]
    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.

  6. Number of participants hospitalized over four months using EHR review and ICD-10s [ Time Frame: 4 months ]
    All-cause hospitalizations will be ascertained via the EHR using ICD-10 codes. Follow-up for hospitalizations will occur through 4 months

  7. 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: 3.5 yrs ]
    Attending or logging 36 sessions

  8. 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: 3.5 yrs ]
    Healthcare utilization, defined by routine clinical visits. urgent care and emergency department visits will be measured using EHR.

  9. Safety measures to track injury from exercise will be assessed using EHR [ Time Frame: 3.5 yrs ]

    Injury from exercise will be assessed using EHR consider 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.


  10. Socioeconomic and clinical data will be collected from EHR. [ Time Frame: 3.5 yrs ]
    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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of acute myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, valvular heart surgery, chronic stable angina, and/or chronic stable heart failur ewith left ventricular systolic dysfunction.
  • 18 year of age or older
  • access to a cell phone with text messaging capability
  • English or Spanish speaking

Exclusion Criteria:

  • medical director's decision based on high-risk assessment
  • enrolled in hospice or palliative care
  • being intoxicated or otherwise unable to consent to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834155


Contacts
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Contact: Sarah E Leslie, MPH 303-602-3805 sarah.leslie@dhha.org
Contact: Pamela Peterson, MD, MSPH pamela.peterson@ucdenver.edu

Locations
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United States, Colorado
Denver Health and Hospital Authority Not yet recruiting
Denver, Colorado, United States, 80204
Contact: Sarah E Leslie, MPH    303-602-3805    sarah.leslie@dhha.org   
Contact: Pamela Peterson, MD, MPH       pamela.peterson@dhha.org   
Principal Investigator: Pamela Peterson, MD, MPH         
Sponsors and Collaborators
Denver Health and Hospital Authority
Investigators
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Principal Investigator: Pamela Peterson, MD, MSPH Denver Health and Hospital Authority

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Responsible Party: Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT03834155     History of Changes
Other Study ID Numbers: 18-1290
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Failure
Coronary Artery Disease
Coronary Disease
Heart Diseases
Infarction
Myocardial Ischemia
Myocardial Infarction
Angina, Stable
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms