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

Aortic Valve Disease Clinical Trial

— OPTIMAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106451
• Other study ID #: IRB00324628
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: Charles Brown, MD
• Phone: 410-955-9918
• Email: cbrownv[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: April 1, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Replacement

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	The Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Catalyst Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Cardiac Rehabilitation Sessions Attended	This outcome will measure the number of cardiac rehabilitation sessions attended by the participant.	Approximately 20 weeks after the day of the TAVR procedure
Secondary	Number of Barriers to Attending Cardiac Rehabilitation Sessions	This outcome will measure any self-reported barriers that patients experience to participating in cardiac rehabilitation sessions.	Approximately 20 weeks after the day of the TAVR procedure
Secondary	Health Status as assessed by the EuroQol 5 Dimension 5 Level (EQ-5D-5L)	This survey is a standardized measure of health status. This survey is scored in two separate sections. The first section measures the five dimensions mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The first section is measured by a minimum score of 5 and a maximum score of 25. Higher score greater level of problems. The second section measures self report health status on a 0 to 100. Higher score best health.	Approximately 20 weeks after the day of the TAVR procedure
Secondary	Health Status as assessed by the The Kansas City Cardiomyopathy Questionnaire (KCCQ)	The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a survey used to measure health status in patients with heart failure. The KCCQ scores four domains and one summary score. The four domains are physical limitations score, symptom frequency score, quality of life score, and the social limitations score. These five scores are scaled on a scale of 0 to 100. Higher score better health status.	20 weeks after the day of the TAVR procedure
Secondary	Disability as assessed by the World Health Organization Disability Assessment Schedule (WHO-DAS 2.0)	This survey measures disability due to health conditions including diseases, illnesses, injuries, mental or emotional problems, and problems with alcohol and drugs. This survey has a minimum score of 12 and a maximum score of 60. Higher scores more disability.	Approximately 20 weeks after the day of the TAVR procedure
Secondary	Potential Depression as assessed by the Geriatric Depression Scale	This survey is a self-reported measure of potential depression in older adults. The minimum score for this survey is 0 and the maximum score is 15. A score of 5 or greater suggests depression.	20 weeks after the day of the TAVR procedure
Secondary	Safety Events	Any events adverse events or serious adverse events that occur while the patient is participating in the study.	Approximately 20 weeks after the day of the TAVR procedure
Secondary	Number of steps as assessed by the 2-Minute Step Test	This test measures the number of steps the patient can take in 2 minutes time. The number of steps recorded is compared to a standardized range of steps based on age.	Approximately 20 weeks after the day of the TAVR procedure
Secondary	Number of stands from sitting as assessed by the 30-Second Chair Rise	This test records the number of stands from sitting the patient can complete in 30 seconds time. The number of stands the patient can complete is compared to the average number is compared to the average number in the patient's age group.	Approximately 20 weeks after the day of the TAVR procedure
Secondary	The Duration of the Motivational Interviewing Sessions	This outcome will measure the length of each motivational interviewing session attended.	Approximately 20 weeks after the day of the TAVR procedure
Secondary	Patient Satisfaction With the Assigned Program	Patient satisfaction will be measured using a Likert scale from 1 to 5. 1 indicates the patient is very dissatisfied. 5 indicates the patient is very satisfied.	Approximately 20 weeks after the day of the TAVR procedure
Secondary	Number of Contacts with the Study Physical Therapist	This outcome measure the number of times the patient has contact with the study physical therapy.	Approximately 20 weeks after the day of the TAVR procedure
Secondary	Number of steps taken as assessed by Fitbit Data	This outcome will measure activity (e.g. number of steps taken) while wearing the Fitbit.	Approximately 20 weeks after the day of the TAVR procedure