Enhancing Cardiac Rehabilitation Through Behavioral Nudges
1 other identifier
interventional
447
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2018
CompletedFirst Posted
Study publicly available on registry
February 7, 2019
CompletedStudy Start
First participant enrolled
May 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedMay 13, 2025
May 1, 2025
4 years
December 20, 2018
May 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Adherence to cardiovascular rehabilitation measured by self-report in the Movn Application or through EHR/exercise physiologist report in RedCap
Attendance for 4 weeks (8 or more) exercise sessions for hospital-based CR or logging exercise data for 4 weeks for home-based rehabilitation.
12 weeks
Secondary Outcomes (10)
Active enrollment of 280 DH participants
3.5 yrs
Completion of cardiovascular rehabilitation as defined by attending or logging 18 exercise sessions
12 weeks
Exercise capacity measured by a 6-minute walk test.
12 weeks
Patient activation and engagement will be measured using the 13-item Patient Activation Measure (PAM)
12 weeks
Reported quality of life measured by Ferrans and Powers Quality of Life Index
12 weeks
- +5 more secondary outcomes
Study Arms (4)
Hospital-based CR + Mobile Application
EXPERIMENTALTraditional hospital-based cardiac rehabilitation with mobile application.
Choice CR + Mobile Application
EXPERIMENTALChoice of hospital or home-based cardiac rehabilitation with mobile application.
Hospital-based CR + Mobile Application + Nudge
EXPERIMENTALHospital-based cardiac rehabilitation with mobile application and nudges.
Choice CR + Mobile Application + Nudges
EXPERIMENTALChoice of Hospital or home-based cardiac rehabilitation with mobile application and nudges.
Interventions
Participants will be randomly assigned to a group that will receive hospital-based CR and access to the Movn mobile 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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- year of age or older
- Access to a cell phone with text messaging capability
- English or Spanish speaking
You may not qualify if:
- Medical director's decision based on high-risk assessment
- Enrolled in hospice or palliative care
- Being intoxicated or otherwise unable to consent to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
Related Publications (1)
Gupta P, Fletcher DR, Durfee J, Martinez M, Hajoglou A, Waughtal J, Bull S, Peterson PN. Enhancing cardiac rehabilitation adherence through home-based rehabilitation and behavioral nudges: The ERA nudge study design and rationale. Am Heart J. 2025 Dec;290:17-28. doi: 10.1016/j.ahj.2025.05.010. Epub 2025 May 16.
PMID: 40383506DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela Peterson, MD, MSPH
Denver Health and Hospital Authority
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2018
First Posted
February 7, 2019
Study Start
May 17, 2019
Primary Completion
May 26, 2023
Study Completion
August 31, 2024
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share