ACTIVE_NOT_RECRUITING

Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD

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 present study aims to increase Veteran access to supervised exercise therapy and expand its role in improving functional status, quality of life, and cardiovascular risk profile of Veterans with PAD.

Official Title

Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD (CDA 20-073)

Quick Facts

Study Start:2021-12-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05048979

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. * Diagnosis of PAD, defined as a history of an ankle-brachial index (ABI) of 0.90, prior revascularization of a lower limb for symptomatic disease more than 30 days prior to presentation, or ABI \>0.90 with evidence of PAD based on noninvasive vascular laboratory testing or angiography
  2. * \[and presence of claudication, defined as fatigue, discomfort, cramping or pain of vascular origin in the muscles of the lower extremities that is consistently induced by exercise and consistently relieved by rest within 10 minutes.\]
  3. * In addition, participants will require access to cellular signal at place of residence and/or exercise location
  1. * Justification for exclusion criteria centers on inability to safely participate in the remote intervention. Specific exclusion criteria includes the following:
  2. * major lower extremity amputation
  3. * critical limb ischemia
  4. * inability to ambulate without a walker or wheelchair
  5. * significant visual or hearing impairment
  6. * individuals whose function is limited by severe conditions such as severe ischemic heart disease or \> Class II NYHA heart failure
  7. * individuals capable of ambulating at a level comparable to the amount of exercise to be prescribed at baseline
  8. * individuals currently enrolled in another exercise trial or cardiac rehab program
  9. * individuals with uncontrolled psychiatric illness or dementia
  10. * categorically vulnerable
  11. * pregnant women, prisoners, children, or persons who lack decision-making capacity

Contacts and Locations

Principal Investigator

Jorge Antonio Gutierrez, MD
PRINCIPAL_INVESTIGATOR
Durham VA Medical Center, Durham, NC

Study Locations (Sites)

Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Jorge Antonio Gutierrez, MD, PRINCIPAL_INVESTIGATOR, Durham VA Medical Center, Durham, NC

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 Date2021-12-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-12-01
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Peripheral Artery Disease