Status:
COMPLETED
Virtual Visits to Optimize Research Trial Offerings to HF Patients
Lead Sponsor:
The Cleveland Clinic
Conditions:
Heart Failure, Systolic
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This pilot study seeks to understand if distance health technology with virtual visits hold the key to improving access for patients who wish to partake in clinical trials clearing barriers to enrollm...
Detailed Description
Patient participation in clinical trials is crucial to ultimately shaping change in care delivery and development of new treatments that improve quality of life and meaningful patient outcomes. While ...
Eligibility Criteria
Inclusion
- Males or Females
- Aged \>18 years
- Diagnosed with HFpEF (preserved EF) or HFrEF (reduced EF)
- Patient has a distance to walk at home of at least 10m/30 feet up to a maximum 15m/50 feet.
- The distance anticipated to be used at home is to be used in clinic)(Ex: 1-3 average car lengths, width of a high school basketball court, 2/3 to1and2/3 lengths of a tour bus, 30-50 rulers end to end, 30-50 sub-sandwiches end to end)
- Having standard of care clinical evaluations performed at the Cleveland Clinic Main Campus.
- Willing to perform distance health evaluations during study participation.
- Patient or an individual in their social support network has the equipment (phone, computer, tablet) and internet connection to perform a distance health research visit.
Exclusion
- Unstable Angina or Myocardial infarction within the past 1 month.
- History of Heart Transplant or actively listed for heart or any solid organ or tissue transplant
- Implanted with an left ventricular assist device (LVAD)
- Scheduled to be implanted with a left ventricular assist device (LVAD) within 45 days of signing consent.
- Currently residing at a nursing home or rehabilitation facility.
- Currently receiving Hospice services
- Malignancy or other condition limiting life expectancy to less than 6 months.
- Inability to walk without assist (cane is acceptable)
- Inability or unwillingness to comply with study requirements in the opinion of the investigator
- Inability to provide informed consent.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04064541
Start Date
August 1 2019
End Date
March 30 2020
Last Update
August 17 2020
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195