NCT03834155

Enhancing Cardiac Rehabilitation Through Behavioral Nudges

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 447 (actual)
• Sponsor: Denver Health and Hospital Authority · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Myocardial Infarction
• Percutaneous Coronary Intervention
• Coronary Artery Disease
• Valvular Disease
• Chronic Stable Angina
• Chronic Stable Heart Failure

Interventions

Type	Name	Description
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.
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.
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.
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.

Timeline

• Start date: 2019-05-17
• Primary completion: 2023-05-26
• Completion: 2024-08-31
• First posted: 2019-02-07
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States