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

Study Overview
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Brief Summary
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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.

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

Conditions
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Aortic Valve Disease, Aortic Valve Replacement

Intervention / Treatment
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* Behavioral: Standard of Care plus Enhanced Patient Education
* Behavioral: Motivational Interviewing Intervention
* Behavioral: Home-Based Activity Program plus Motivational Interviewing Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to one of the 3 arms of the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care plus Enhanced Patient Education<br>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<br>* 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.<br>|
| Active Comparator: Motivational Interviewing Intervention<br>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<br>* 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.<br>|
| Active Comparator: Home-Based Activity Program plus Motivational Interviewing Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic valve replacement, minimally invasive transcatheter aortic valve replacement, TAVR