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

NCT06106451 | Completed

• 1 other identifier: IRB00324628
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

aortic valve replacement; minimally invasive transcatheter aortic valve replacement; TAVR

Outcome Measures

Primary Outcomes (2)

• Number of motivational interviewing sessions attended

  This outcome will measure the number of motivational interviewing sessions in which the patient participates. Motivational Interviewing Arm Outcome.

  Approximately 20 weeks after the day of the TAVR procedure

• Number of home-based activity sessions attended

  This outcome will measure the number of home-based activity sessions the patient logs. Home-based Activity Arm

  Approximately 20 weeks after the day of the TAVR procedure

Secondary Outcomes (13)

• Number of Cardiac Rehabilitation Sessions Attended

  Approximately 20 weeks after the day of the TAVR procedure

• Number of Barriers to Attending Cardiac Rehabilitation Sessions

  Approximately 20 weeks after the day of the TAVR procedure

• Health Status as assessed by the EuroQol 5 Dimension 5 Level (EQ-5D-5L)

  Approximately 20 weeks after the day of the TAVR procedure

• Health Status as assessed by the The Kansas City Cardiomyopathy Questionnaire (KCCQ)

  20 weeks after the day of the TAVR procedure

• Disability as assessed by the World Health Organization Disability Assessment Schedule (WHO-DAS 2.0)

  Approximately 20 weeks after the day of the TAVR procedure

Study Arms (3)

Standard of Care plus Enhanced Patient Education

ACTIVE COMPARATOR

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.

Behavioral: Standard of Care plus Enhanced Patient Education

Motivational Interviewing Intervention

ACTIVE COMPARATOR

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.

Behavioral: Motivational Interviewing Intervention

Home-Based Activity Program plus Motivational Interviewing Intervention

ACTIVE COMPARATOR

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.

Behavioral: Home-Based Activity Program plus Motivational Interviewing Intervention

Interventions

Standard of Care plus Enhanced Patient Education 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.

Standard of Care plus Enhanced Patient Education

Motivational Interviewing Intervention 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.

Motivational Interviewing Intervention

Home-Based Activity Program plus Motivational Interviewing Intervention 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.

Home-Based Activity Program plus Motivational Interviewing Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Catalyst Foundation: collaborator

Study Sites (1)

The Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Standard of Care; Motivational Interviewing

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Charles Brown, MD

  Johns Hopkins Uiversity

  STUDY DIRECTOR

• Giancarlo Suffredini, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to one of the 3 arms of the study.

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: January 29, 2024
• Primary Completion: October 14, 2025
• Study Completion: November 3, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)