Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
United States
Maryland
The Johns Hopkins University
RECRUITING
Baltimore
Contact Information
Primary
Charles Brown, MD
cbrownv@jhmi.edu
410-955-9918
Backup
Mirinda Anderson White, RN
mander47@jhmi.edu
410-955-6488
Time Frame
Start Date: 2024-01-29
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 55
Treatments
Active_comparator: 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.
Active_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Catalyst Foundation
Leads: Johns Hopkins University