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

Summary

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.

Conditions

• Aortic Valve Disease
• Aortic Valve Replacement

Interventions

BEHAVIORAL

Standard of Care plus Enhanced Patient Education

Patients in this arm will receive a pamphlet explaining the benefits of cardiac rehabilitation. This pamphlet will be given in addition to standard of care patient education. The research team will also call the patient at four specified time points to provide additional information.

BEHAVIORAL

Motivational Interviewing Intervention

Patients in this arm of the study will participate in a tailor-made motivational interviewing program. These motivational interviewing sessions will focus on enhancing communication with patients. Each motivational interviewing session will be approximately one hour long. There will be a total of 4-6 motivational interviewing sessions.

BEHAVIORAL

Home-Based Activity Program plus Motivational Interviewing Intervention

Patients in this arm will be evaluated on postoperative day 1 by a physical therapist on the study team. After the evaluation, the physical therapist will use the information from the evaluation to make a tailored home-based physical activity program for the patient. The patient will begin the home-based physical activity program on the day of their 1-month post-operative cardiology clinic appointment. In addition to the home-based activity program, patients will participate in a tailor-made motivational interviewing program. These motivational interviewing sessions will focus on enhancing communication with patients. Each motivational interviewing session will be approximately one hour long. There will be a total of 4-6 motivational interviewing sessions.

Sponsors & Collaborators

• Catalyst Foundation

  collaborator UNKNOWN

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Charles Brown, MD · Johns Hopkins Uiversity

• Giancarlo Suffredini, MD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-29

Primary Completion

2025-10-14

Completion

2025-11-03

Countries

• United States

Study Locations