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Home-Based Activity and Motivation Program for Aortic Valve Replacement Recovery (OPTIMAL Trial)

N/A

Recruiting

Led By Charles Brown, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing TAVR procedure

Ambulatory at baseline without assistance

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 20 weeks after the day of the tavr procedure

Awards & highlights

OPTIMAL Trial Summary

This trial will look at if a program to improve recovery after TAVR (heart valve replacement) is effective. It will compare motivation interviewing, physical activity and usual care.

Who is the study for?

This trial is for individuals aged 65 or older who are undergoing a TAVR procedure, can walk without help, have their cardiologist's approval to participate, and can use a phone or teleconference. It excludes those with severe cognitive issues, major heart problems like low ejection fraction or cardiac arrest history, high fall risk, regular vigorous exercisers, non-English speakers, and any other conditions deemed unsuitable by a physician.Check my eligibility

What is being tested?

The study tests the effectiveness of two programs aimed at improving activity levels after TAVR: one combines home-based exercises with motivational talks; another just uses motivational talks. These will be compared against standard care plus extra patient education to see which is best at helping patients recover.See study design

What are the potential side effects?

Since this trial focuses on educational and motivational interventions along with physical activities rather than medications or invasive procedures, side effects may include muscle soreness from exercise or emotional distress but are generally expected to be minimal.

OPTIMAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a TAVR procedure.

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I can walk by myself without help.

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I am 65 years old or older.

OPTIMAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 20 weeks after the day of the tavr procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 20 weeks after the day of the tavr procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 20 weeks after the day of the tavr procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of home-based activity sessions attended

Number of motivational interviewing sessions attended

Secondary outcome measures

Disability as assessed by the World Health Organization Disability Assessment Schedule (WHO-DAS 2.0)

Health Status as assessed by the EuroQol 5 Dimension 5 Level (EQ-5D-5L)

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

+10 more

OPTIMAL Trial Design

3Treatment groups

Active Control

Group I: Motivational Interviewing InterventionActive Control1 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.

Group II: Standard of Care plus Enhanced Patient EducationActive Control1 Intervention

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.

Group III: Home-Based Activity Program plus Motivational Interviewing InterventionActive Control1 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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Catalyst FoundationUNKNOWN

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,442 Total Patients Enrolled

Charles Brown, MDPrincipal InvestigatorJohns Hopkins Uiversity

7 Previous Clinical Trials

561 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently enrolling participants for this experiment?

"Data hosted on clinicaltrials.gov indicates that, at present, this particular medical trial is not actively recruiting patients; however it was last updated on October 24th 2023. However, there are 32 other studies which currently require patient enrollment."

Answered by AI

What is the underlying purpose of this clinical experiment?

"The primary goal of this trial, which is planned to last roughly 20 weeks post-TAVR procedure, will be measured by the Number of home-based activity sessions attended. Additionally, we intend to measure secondary outcomes such as: Number of Barriers to Attending Cardiac Rehabilitation Sessions (which gauges any self-reported barriers individuals have regarding their participation in cardiac rehab), Health Status as assessed by the EuroQol 5 Dimension 5 Level (EQ-5D-5L; a standardized survey that yields scores between 5 and 25 with higher numbers indicating greater problems) and Kansas City Cardiomyopathy Questionnaire's four domains"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06106451.