RECRUITING

Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions

Talk to us

Conditions

Valvular Heart Diseasecardiac rehabilitationtranscatheter heart valve interventioncardiologyaortic stenosismitral regurgitationtricuspid regurgitation

Quick Navigation

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

The vast majority of cardiac rehabilitation eligible individuals do not participate in center based cardiac rehabilitation (CBCR). While steps to encourage participation in CBCR are important, many individuals will still not participate for a variety of reasons. This randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients undergoing transcatheter heart valve interventions (THVIs). After a brief roll-in period, participants not intending to participate in CBCR are randomized to one of three groups: (1) control, (2) HBCR mobile health intervention with hands-off delivery, and (3) HBCR mobile health intervention with interactive delivery. Participants in the intervention groups (hands-off/interactive delivery) will also be randomized to continue the intervention for 12 weeks or 24 weeks. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on clinical events, physical activity, quality of life, and other outcomes. Those who intend to participate in CBCR will be followed in a registry.

Official Title

Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions

Quick Facts

Study Start:2023-12-15
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06077201

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Treated with a transcatheter heart valve intervention (e.g., transcatheter aortic valve implantation \[in the native valve or valve-in-valve\], mitral transcatheter edge-to-edge repair, mitral valve-in-valve) of the aortic, mitral, or tricuspid valve done via transfemoral access
  1. * Unwilling or unable to provide informed consent
  2. * Not adherent to wearing the ActiGraph activity tracker during the roll-in phase for a minimum of 4 (out of 7) compliant days (worn \>10 hours/day)
  3. * Planned participation in center based cardiac rehabilitation (CBCR)
  4. * Transcatheter heart valve intervention done via any route other than a transfemoral approach
  5. * Stroke during or immediately after the transcatheter heart valve intervention prior to randomization
  6. * Placement of a pacemaker within 6 weeks prior to the transcatheter heart valve intervention or after the transcatheter heart valve intervention and prior to randomization
  7. * Those who require a walker or who cannot get out of a chair/bed on their own and walk independently (use of a cane is acceptable)
  8. * Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments (e.g. blindness, dementia)
  9. * Planned surgery within 6 months after the heart valve intervention
  10. * Planned discharge from hospital to hospice, assisted living, or inpatient rehabilitation facility (discharge to a senior facility permitted as long as they are considered Independent Living)
  11. * Treating provider or site PI indicates that participation in the study would be unsafe
  12. * Participation in any ongoing randomized trial that has not completed follow-up unless the sponsor of the other trial allows enrollment of the participant in this cardiac rehabilitation trial
  13. * Unable to complete the baseline study visit prior to 6 weeks after the transcatheter heart valve intervention

Contacts and Locations

Study Contact

Anna Vatterott, MPH
CONTACT
615-936-5798
anna.vatterott@vumc.org
Caleb Hayes, MPH
CONTACT
caleb.hayes@vumc.org

Principal Investigator

Brian R. Lindman, MD, MSc
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Brian R. Lindman, MD, MSc, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

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 Date2023-12-15
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2023-12-15
Study Completion Date2026-10-01

Terms related to this study

Keywords Provided by Researchers

  • cardiac rehabilitation
  • transcatheter heart valve intervention
  • cardiology
  • aortic stenosis
  • mitral regurgitation
  • tricuspid regurgitation

Additional Relevant MeSH Terms

  • Valvular Heart Disease