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AzTrials

Acute Myocardial InfarctionNCT03834155

Enhancing Cardiac Rehabilitation Through Behavioral Nudges

A study testing Hospital-based CR + Movn Application, Choice of Hospital or home-based CR + Movn Application and Hospital-based CR + Movn Application + Nudge in people with Acute Myocardial Infarction and Percutaneous Coronary Intervention, run by Denver Health and Hospital Authority at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Hospital-based CR + Movn Application, Choice of Hospital or home-based CR + Movn Application and Hospital-based CR + Movn Application + Nudge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
447 participants
Where
1 siteUnited States
Study dates
17 May 2019to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Medical director's decision based on high-risk assessment
  • Enrolled in hospice or palliative care
  • Being intoxicated or otherwise unable to consent to participate

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Denver Health and Hospital Authority

    Denver, Colorado, 80204

Other trials in United States

About this study

Official title: Enhancing Cardiac Rehabilitation Adherence Through Home-based Rehabilitation and Behavioral Nudges: ERA Nudge

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.

Read the 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.

Being tested
Hospital-based CR + Movn Application, Choice of Hospital or home-based CR + Movn Application, Hospital-based CR + Movn Application + Nudge, Choice of Hospital or home-based CR + Movn Application + Nudge
Medical subject headings
Coronary Artery Disease, Angina, Stable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hospital-based CR + Movn ApplicationOther

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

  • Choice of Hospital or home-based CR + Movn ApplicationOther

    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.

  • Hospital-based CR + Movn Application + NudgeOther

    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.

  • Choice of Hospital or home-based CR + Movn Application + NudgeOther

    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.

Study groups in NCT03834155
Study groupRoleWhat they receive
Hospital-based CR + Mobile ApplicationExperimentalTraditional hospital-based cardiac rehabilitation with mobile application.
Receives: Other: Hospital-based CR + Movn Application
Choice CR + Mobile ApplicationExperimentalChoice of hospital or home-based cardiac rehabilitation with mobile application.
Receives: Other: Choice of Hospital or home-based CR + Movn Application
Hospital-based CR + Mobile Application + NudgeExperimentalHospital-based cardiac rehabilitation with mobile application and nudges.
Receives: Other: Hospital-based CR + Movn Application + Nudge
Choice CR + Mobile Application + NudgesExperimentalChoice of Hospital or home-based cardiac rehabilitation with mobile application and nudges.
Receives: Other: Choice of Hospital or home-based CR + Movn Application + Nudge

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (10)

  1. Active enrollment of 280 DH participants

    Attending one visit following baseline visit or logging exercise data at least once for home-based CR.

    Measured: 3.5 yrs

  2. Completion of cardiovascular rehabilitation as defined by attending or logging 18 exercise sessions

    Attending or logging 18 exercise sessions

    Measured: 12 weeks

  3. Exercise capacity measured by a 6-minute walk test.

    Exercise capacity will be measured at the index visit, 6 weeks, 12 weeks.

    Measured: 12 weeks

  4. Patient activation and engagement will be measured using the 13-item Patient Activation Measure (PAM)

    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.

    Measured: 12 weeks

  5. Reported quality of life measured by Ferrans and Powers Quality of Life Index

    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.

    Measured: 12 weeks

  6. Number of participants hospitalized over four months using EHR review and ICD-10s

    All-cause hospitalizations will be ascertained via the EHR using ICD-10 codes. Follow-up for hospitalizations will occur through 6 months.

    Measured: 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

    Attending or logging 36 exercise sessions.

    Measured: 12 weeks

  8. Type of healthcare utilization by individual participants, defined by routine clinical visits. Urgent care and emergency department visits will be measured using EHR.

    Healthcare utilization, defined by routine clinical visits. Urgent care and emergency department visits will be measured using EHR.

    Measured: 6 months

  9. Safety measures to track injury from exercise will be assessed using EHR

    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.

    Measured: 12 weeks

  10. Socioeconomic and clinical data will be collected from EHR.

    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.

    Measured: 3.5 yrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2019
  2. Study start17 May 2019
  3. Primary completion26 May 2023
  4. Study completion31 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
447 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03834155
Sponsor's protocol ID
18-1290
Status last verified
May 2025
First submitted
20 Dec 2018
Last updated
13 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40383506

Questions about this trial

What is this clinical trial studying?

A study testing Hospital-based CR + Movn Application, Choice of Hospital or home-based CR + Movn Application and Hospital-based CR + Movn Application + Nudge in people with Acute Myocardial Infarction and Percutaneous Coronary Intervention, run by Denver Health and Hospital Authority at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03834155, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.

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