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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834155
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : August 18, 2021
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. 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.

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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
Actual Study Start Date : May 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 + Mobile Application
Traditional hospital-based cardiac rehabilitation with 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 cardiac rehabilitation with mobile 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 + Mobile Application + Nudge
Hospital-based cardiac rehabilitation with 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 + Nudges
Choice of Hospital or home-based cardiac rehabilitation with mobile application and nudges.
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: 12 weeks ]
    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: 12 weeks ]
    Attending or logging 18 exercise sessions

  3. Exercise capacity measured by a 6-minute walk test. [ 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. 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: 6 months ]
    All-cause hospitalizations will be ascertained via the EHR using ICD-10 codes. Follow-up for hospitalizations will occur through 6 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: 12 weeks ]
    Attending or logging 36 exercise 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: 6 months ]
    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: 12 weeks ]

    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.


  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.



Information from the National Library of Medicine

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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 failure with 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: Kevin H Andresen, MPH 303-602-4859 kevin.andresen@dhha.org
Contact: Pamela Peterson, MD, MSPH pamela.peterson@ucdenver.edu

Locations
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United States, Colorado
Denver Health and Hospital Authority Recruiting
Denver, Colorado, United States, 80204
Contact: Kevin H Andresen, MPH    303-602-4859    kevin.andresen@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    
Other Study ID Numbers: 18-1290
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021
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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Coronary Artery Disease
Heart Diseases
Coronary Disease
Myocardial Infarction
Angina, Stable
Infarction
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations