Enhancing Cardiac Rehabilitation Through Behavioral Nudges

August 12, 2021 updated by: Denver Health and Hospital Authority

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Recruiting
        • Denver Health and Hospital Authority
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pamela Peterson, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3.5 yrs
Completion of cardiovascular rehabilitation as defined by attending or logging 18 exercise sessions
Time Frame: 12 weeks
Attending or logging 18 exercise sessions
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
6 months
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.
12 weeks
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.
6 months
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.
12 weeks
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.
3.5 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Denver Health and Hospital Authority

Investigators

  • Principal Investigator: Pamela Peterson, MD, MSPH, Denver Health and Hospital Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2019

Primary Completion (ANTICIPATED)

March 31, 2023

Study Completion (ANTICIPATED)

September 30, 2023

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

February 5, 2019

First Posted (ACTUAL)

February 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-1290

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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