NCT03834155

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
447

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

May 17, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

4 years

First QC Date

December 20, 2018

Last Update Submit

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

EXPERIMENTAL

Traditional hospital-based cardiac rehabilitation with mobile application.

Other: Hospital-based CR + Movn Application

Choice CR + Mobile Application

EXPERIMENTAL

Choice of hospital or home-based cardiac rehabilitation with mobile application.

Other: Choice of Hospital or home-based CR + Movn Application

Hospital-based CR + Mobile Application + Nudge

EXPERIMENTAL

Hospital-based cardiac rehabilitation with mobile application and nudges.

Other: Hospital-based CR + Movn Application + Nudge

Choice CR + Mobile Application + Nudges

EXPERIMENTAL

Choice of Hospital or home-based cardiac rehabilitation with mobile application and nudges.

Other: Choice of Hospital or home-based CR + Movn Application + Nudge

Interventions

Participants will be randomly assigned to a group that will receive hospital-based CR and access to the Movn mobile application.

Hospital-based CR + 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.

Choice CR + Mobile 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.

Hospital-based CR + Mobile 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.

Choice CR + Mobile Application + Nudges

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Coronary Artery DiseaseAngina, Stable

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pamela Peterson, MD, MSPH

    Denver Health and Hospital Authority

    PRINCIPAL INVESTIGATOR

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

Locations