RECRUITING

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

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Conditions

Aortic Valve DiseaseAortic Valve Replacementminimally invasive transcatheter aortic valve replacementTAVR

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2024-01-29
Study Completion:2027-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06106451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Undergoing TAVR procedure
  2. * ≥65 years old
  3. * Ambulatory at baseline without assistance
  4. * Approval of the interventional cardiologist that the patient is an appropriate candidate
  5. * Can access telephone or teleconference
  1. * Impaired cognition that would limit participation in study activities
  2. * Medical comorbidities that substantially limit exercise
  3. * Major cardiac comorbidities, including ejection fraction\<35%, history of cardiac arrest, complex dysrhythmias at rest, clinically-significant incomplete revascularization, implanted cardiac defibrillator.
  4. * Physical characteristics that substantially limit exercise
  5. * High fall risk (Johns Hopkins Fall Risk Assessment Tool indicating high risk)
  6. * Non-English Speaking
  7. * Vigorous exercise at least 2 times/week for \>30 minutes
  8. * Any other physician judgement

Contacts and Locations

Study Contact

Charles Brown, MD
CONTACT
410-955-9918
cbrownv@jhmi.edu
Mirinda Anderson White, RN
CONTACT
410-955-6488
mander47@jhmi.edu

Principal Investigator

Charles Brown, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins Uiversity

Study Locations (Sites)

The Johns Hopkins University
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Charles Brown, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Uiversity

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-29
Study Completion Date2027-04-01

Study Record Updates

Study Start Date2024-01-29
Study Completion Date2027-04-01

Terms related to this study

Keywords Provided by Researchers

  • aortic valve replacement
  • minimally invasive transcatheter aortic valve replacement
  • TAVR

Additional Relevant MeSH Terms

  • Aortic Valve Disease
  • Aortic Valve Replacement