Clinical trial NCT06106451: Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)
Official title: Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Disease
Aortic Valve Replacement
Keywords: aortic valve replacement
minimally invasive transcatheter aortic valve replacement
TAVR
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Catalyst Foundation
First posted: 2023-10-30
Enrollment: 55
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to one of the 3 arms of the study.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Number of motivational interviewing sessions attended
timeFrame: Approximately 20 weeks after the day of the TAVR procedure
measure: Number of home-based activity sessions attended
timeFrame: Approximately 20 weeks after the day of the TAVR procedure
Secondary outcomes:
measure: Number of Cardiac Rehabilitation Sessions Attended
timeFrame: Approximately 20 weeks after the day of the TAVR procedure
measure: Number of Barriers to Attending Cardiac Rehabilitation Sessions
timeFrame: Approximately 20 weeks after the day of the TAVR procedure
measure: Health Status as assessed by the EuroQol 5 Dimension 5 Level (EQ-5D-5L)
timeFrame: Approximately 20 weeks after the day of the TAVR procedure
measure: Health Status as assessed by the The Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 20 weeks after the day of the TAVR procedure
measure: Disability as assessed by the World Health Organization Disability Assessment Schedule (WHO-DAS 2.0)
timeFrame: Approximately 20 weeks after the day of the TAVR procedure
measure: Potential Depression as assessed by the Geriatric Depression Scale
timeFrame: 20 weeks after the day of the TAVR procedure
measure: Safety Events
timeFrame: Approximately 20 weeks after the day of the TAVR procedure
measure: Number of steps as assessed by the 2-Minute Step Test
timeFrame: Approximately 20 weeks after the day of the TAVR procedure
measure: Number of stands from sitting as assessed by the 30-Second Chair Rise
timeFrame: Approximately 20 weeks after the day of the TAVR procedure
measure: The Duration of the Motivational Interviewing Sessions
timeFrame: Approximately 20 weeks after the day of the TAVR procedure
measure: Patient Satisfaction With the Assigned Program
timeFrame: Approximately 20 weeks after the day of the TAVR procedure
measure: Number of Contacts with the Study Physical Therapist
timeFrame: Approximately 20 weeks after the day of the TAVR procedure
measure: Number of steps taken as assessed by Fitbit Data
timeFrame: Approximately 20 weeks after the day of the TAVR procedure
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins Uiversity
name: Charles Brown, MD
role: STUDY_DIRECTOR
affiliation: Johns Hopkins University
name: Giancarlo Suffredini, MD
role: PRINCIPAL_INVESTIGATOR
References: