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

Johns Hopkins University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Aortic Valve Disease Aortic Valve Replacement

Interventions

Standard of Care plus Enhanced Patient EducationBEHAVIORAL

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 InterventionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

The Johns Hopkins University

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: Approximately 20 weeks after the day of the TAVR procedure

Secondary Outcomes

Number of Cardiac Rehabilitation Sessions Attended

This outcome will measure the number of cardiac rehabilitation sessions attended by the participant.

Time frame: 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.

Time frame: 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.

Time frame: Approximately 20 weeks after the day of the TAVR procedure

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

Data from ClinicalTrials.gov

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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.

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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 during periods of valid wear.

Time frame: Approximately 20 weeks after the day of the TAVR procedure