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

NCT ID: NCT06106451

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2027-04-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Standard of Care plus Enhanced Patient Education

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care plus Enhanced Patient Education

Intervention Type: BEHAVIORAL

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.

Motivational Interviewing Intervention

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.

Group Type: ACTIVE_COMPARATOR

Motivational Interviewing Intervention

Intervention Type: BEHAVIORAL

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.

Home-Based Activity Program plus Motivational Interviewing Intervention

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.

Group Type: ACTIVE_COMPARATOR

Home-Based Activity Program plus Motivational Interviewing Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catalyst Foundation

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Brown, MD

Role: STUDY_DIRECTOR

Johns Hopkins Uiversity

Giancarlo Suffredini, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

The Johns Hopkins University

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Charles Brown, MD

Role: CONTACT

cbrownv@jhmi.edu

410-955-9918

Mirinda Anderson White, RN

Role: CONTACT

mander47@jhmi.edu

410-955-6488

Facility Contacts

Charles Brown, MD

Role: primary

cbrown12@jhmi.edu

410-955-9918

Mirinda Anderson, RN

Role: backup

mander47@jhmi.edu

410-955-6488

Other Identifiers

IRB00324628

Identifier Type: -

Identifier Source: org_study_id