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Aortic Valve DiseaseOPTIMALNCT06106451

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

A study testing Motivational Interviewing Intervention and Home-Based Activity Program plus Motivational Interviewing Intervention in people with Aortic Valve Disease and Aortic Valve Replacement, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Motivational Interviewing Intervention and Home-Based Activity Program plus Motivational Interviewing Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
29 Jan 2024to 3 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Johns Hopkins University

    Baltimore, Maryland, 21287

Other trials in United States

About this study

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.

Being tested
Standard of Care plus Enhanced Patient Education, Motivational Interviewing Intervention, Home-Based Activity Program plus Motivational Interviewing Intervention
Keywords
aortic valve replacement, minimally invasive transcatheter aortic valve replacement, TAVR
Medical subject headings
Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of Care plus Enhanced Patient EducationBehavioural

    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 InterventionBehavioural

    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 InterventionBehavioural

    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.

Study groups in NCT06106451
Study groupRoleWhat they receive
Standard of Care plus Enhanced Patient EducationActive comparatorEach 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.
Receives: Behavioral: Standard of Care plus Enhanced Patient Education
Motivational Interviewing InterventionActive comparatorEach 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.
Receives: Behavioral: Motivational Interviewing Intervention
Home-Based Activity Program plus Motivational Interviewing InterventionActive comparatorEach 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.
Receives: Behavioral: Home-Based Activity Program plus Motivational Interviewing Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Approximately 20 weeks after the day of the TAVR procedure

  2. 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

    Measured: Approximately 20 weeks after the day of the TAVR procedure

Secondary outcomes (13)

  1. Number of Cardiac Rehabilitation Sessions Attended

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

    Measured: Approximately 20 weeks after the day of the TAVR procedure

  2. 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.

    Measured: Approximately 20 weeks after the day of the TAVR procedure

  3. 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.

    Measured: Approximately 20 weeks after the day of the TAVR procedure

  4. 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.

    Measured: 20 weeks after the day of the TAVR procedure

  5. 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.

    Measured: Approximately 20 weeks after the day of the TAVR procedure

  6. 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.

    Measured: 20 weeks after the day of the TAVR procedure

  7. Safety Events

    Any events adverse events or serious adverse events that occur while the patient is participating in the study.

    Measured: Approximately 20 weeks after the day of the TAVR procedure

  8. 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.

    Measured: Approximately 20 weeks after the day of the TAVR procedure

  9. 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.

    Measured: Approximately 20 weeks after the day of the TAVR procedure

  10. The Duration of the Motivational Interviewing Sessions

    This outcome will measure the length of each motivational interviewing session attended.

    Measured: Approximately 20 weeks after the day of the TAVR procedure

  11. 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.

    Measured: Approximately 20 weeks after the day of the TAVR procedure

  12. Number of Contacts with the Study Physical Therapist

    This outcome measure the number of times the patient has contact with the study physical therapy.

    Measured: Approximately 20 weeks after the day of the TAVR procedure

  13. 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.

    Measured: Approximately 20 weeks after the day of the TAVR procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start29 Jan 2024
  3. Primary completion14 Oct 2025
  4. Study completion3 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized to one of the 3 arms of the study.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06106451
Sponsor's protocol ID
IRB00324628
Acronym
OPTIMAL
Status last verified
Feb 2026
First submitted
24 Oct 2023
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD is anticipated to be shared

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Interviewing Intervention and Home-Based Activity Program plus Motivational Interviewing Intervention in people with Aortic Valve Disease and Aortic Valve Replacement, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of motivational interviewing sessions attended (time frame: Approximately 20 weeks after the day of the TAVR procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06106451.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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