Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)

Johns Hopkins University

Status: Enrolling

Conditions: Aortic Valve Replacement; Aortic Valve Disease

Treatments: Behavioral: Home-Based Activity Program plus Motivational Interviewing Intervention; Behavioral: Standard of Care plus Enhanced Patient Education; Behavioral: Motivational Interviewing Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06106451

IRB00324628

Details and patient eligibility

About

In this study, the investigators will evaluate the feasibility and potential efficacy of programs to improve functional outcomes after minimally-invasive transcatheter aortic valve replacement (TAVR). The investigators will examine the potential efficacy of (a) a motivation interviewing program, and (b) a home-based physical activity + motivational interviewing program, compared to (c) usual care + enhanced education in patients post-TAVR procedure.

Enrollment: 55 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing TAVR procedure
• ≥65 years old
• Ambulatory at baseline without assistance
• Approval of the interventional cardiologist that the patient is an appropriate candidate
• Can access telephone or teleconference

Exclusion criteria

• Impaired cognition that would limit participation in study activities
• Medical comorbidities that substantially limit exercise
• Major cardiac comorbidities, including ejection fraction<35%, history of cardiac arrest, complex dysrhythmias at rest, clinically-significant incomplete revascularization, implanted cardiac defibrillator.
• Physical characteristics that substantially limit exercise
• High fall risk (Johns Hopkins Fall Risk Assessment Tool indicating high risk)
• Non-English Speaking
• Vigorous exercise at least 2 times/week for >30 minutes
• Any other physician judgement

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 3 patient groups

Standard of Care plus Enhanced Patient Education

Active Comparator group

Description:

Each participant in this arm will receive enhanced patient education. The research staff will discuss the benefits of cardiac rehabilitation and provide a pamphlet describing the benefits discussed. The research staff will also call the patient four times throughout their participation in the study to encourage physical activity. The enhanced patient education program will begin approximately 2 weeks after the TAVR procedure.

Treatment:

Behavioral: Standard of Care plus Enhanced Patient Education

Motivational Interviewing Intervention

Active Comparator group

Description:

Each participant in this arm will have a motivational interviewing program created by a psychologist. The motivational interviewing program will be tailored to the individual participant. The goal of the motivational interviewing program is improved adherence to standard of care cardiac rehabilitation. The motivational interviewing program will begin approximately 2 weeks after the TAVR procedure.

Treatment:

Behavioral: Motivational Interviewing Intervention

Home-Based Activity Program plus Motivational Interviewing Intervention

Active Comparator group

Description:

Each participant in this arm will be evaluated by a physical therapist and psychologist. The physical therapist will use the evaluation to create an individually tailored home-based activity program plan. This home-based activity program will be implemented at the 1-month post-operative cardiology clinic appointment. The psychologist will use the evaluation to create an individually tailored motivational interviewing program. The motivational interviewing program will begin approximately 2 weeks after the TAVR procedure.

Treatment:

Behavioral: Home-Based Activity Program plus Motivational Interviewing Intervention