Enhancing Cardiac Rehabilitation Through Behavioral Nudges

Denver Health and Hospital Authority

Status: Completed

Conditions: Coronary Artery Disease; Chronic Stable Heart Failure; Percutaneous Coronary Intervention; Valvular Disease; Acute Myocardial Infarction; Chronic Stable Angina

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03834155

18-1290

Details and patient eligibility

About

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.

Full 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.

Enrollment: 447 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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447 participants in 4 patient groups

Hospital-based CR + Mobile Application

Experimental group

Description:

Traditional hospital-based cardiac rehabilitation with mobile application.

Treatment:

Other: Hospital-based CR + Movn Application

Choice CR + Mobile Application

Experimental group

Description:

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

Treatment:

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

Hospital-based CR + Mobile Application + Nudge

Experimental group

Description:

Hospital-based cardiac rehabilitation with mobile application and nudges.

Treatment:

Other: Hospital-based CR + Movn Application + Nudge

Choice CR + Mobile Application + Nudges

Experimental group

Description:

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

Treatment:

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