Virtual Visits to Optimize Research Trial Offerings to HF Patients

NCT ID: NCT04064541

Last Updated: 2020-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-03-30

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 enrollment.

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 they hold much value, the time and resources patients must allot to participation in protocol requirements of some clinical trials can be a barrier to trial enrollment. With the advent of Distance Health, and Virtual Visits in particular, accompanied by an increase in patient utilization of home computers and smart phones, patients are swarming to different communication platforms with their care providers. We hypothesize that distance health technology with virtual visits hold the key to improving access for patients who wish to partake in clinical trials, clearing barriers to enrollment.

If the virtual administration of clinical trial assessments is non-inferior to the tests regularly administered during in-clinic research related visits, this approach should be adopted by industry-sponsored and investigator initiated research studies in heart failure cohorts. If patients have the technological means and willingness to participate in the study, the ability to perform these tests in the comfort of their own home will likely make clinical trial enrollment more attractive and feasible for the patient. Furthermore, increasing clinical trial enrollment by diminishing access barriers will improve patient care by including a more diverse patient population in study enrollment and decrease study follow up attrition rates.

At the baseline visit prior to consent, potential subjects will be shown the distance of 30-50 feet while in the clinic setting, in order to determine if walking distance is feasible in the home environment. Once consented patients will complete an in-clinic baseline visit consisting of Medical Hx review, New York Hospital Association (NYHA) assessment, Questionnaires (EQ-5D-5L, KCCQ, Frailty Index for Elders & Mini Cog) and Functional Assessments (Timed Up & Go and 6MWT). Patients will also receive virtual visit training. Efforts will be made to enroll subjects from all the various NYHA class distinctions (II,III,IV). A baseline virtual visit will be completed in the clinic setting to ensure patient can perform the functional portion of the virtual visit in the home.

All follow-up visits will occur via virtual distance health visits. These f/u visits will occur 2 times after the initial baseline visit (Day 7and Day 14 [+/- 3 days for all f/u time points]. It is felt that 2 f/u visits completed in the home will reflect adequate data regarding feasibility for performing the procedures in the home environment while also reflecting the real time changing functional fluctuations of the patient with chronic HF. At the initiation of each distance health f/u visit the patient's current state of health will be assessed as well as NYHA. Questions will be asked of the patient to assess any changes in medical condition since the previous visit. Visit procedures will be rescheduled if the patient indicates that they are not feeling up to completing the study procedures on the scheduled day. Patient Questionnaires(EQ-5D-5L, KCCQ & Frailty Index) and Functional Assessments(Timed Up & Go and 6MWT) will be completed.

In order to complete the study procedures in the home during the distance health visits, patients will be provided with 2 cones and a measuring tape for marking the distances for the functional assessment tests.

If at anytime, the subject indicates distress or injury (ex: falling) while performing study procedures, the research staff will call 911 on the patient's behalf.

Conditions

Heart Failure, Systolic; Heart Failure With Preserved Ejection Fraction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Virtual Visit

At the baseline visit patients will complete an in-clinic baseline visit consisting of Medical Hx review, NYHA assessment, Questionnaires (EQ-5D-5L, KCCQ, Frailty Index for Elders & Mini Cog) and Functional Assessments (Timed Up & Go and 6MWT). Patients will also receive virtual visit training and complete an in-clinic virtual visit consisting of the previously stated functional assessments.

All follow-up visits will occur via virtual distance health visits. These f/u visits will occur at Day 7and Day 14 At the initiation of each distance health f/u visit the patient's current state of health will be assessed as well as NYHA. Patient Questionnaires(EQ-5D-5L, KCCQ & Frailty Index) and Functional Assessments(Timed Up & Go and 6MWT) will be completed.

Group Type: OTHER

Virtual Visit

Intervention Type: OTHER

Virtual Visit

Interventions

Virtual Visit

Virtual Visit

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Males or Females

2. Aged >18 years

3. Diagnosed with HFpEF (preserved EF) or HFrEF (reduced EF)

4. 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)

5. Having standard of care clinical evaluations performed at the Cleveland Clinic Main Campus.

6. Willing to perform distance health evaluations during study participation.

7. 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 Criteria

1. Unstable Angina or Myocardial infarction within the past 1 month.

2. History of Heart Transplant or actively listed for heart or any solid organ or tissue transplant

3. Implanted with an left ventricular assist device (LVAD)

4. Scheduled to be implanted with a left ventricular assist device (LVAD) within 45 days of signing consent.

5. Currently residing at a nursing home or rehabilitation facility.

6. Currently receiving Hospice services

7. Malignancy or other condition limiting life expectancy to less than 6 months.

8. Inability to walk without assist (cane is acceptable)

9. Inability or unwillingness to comply with study requirements in the opinion of the investigator

10. Inability to provide informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Laurie Ann Moennich

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laurie Ann Moennich, MPH CPH

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

19-818

Identifier Type: -

Identifier Source: org_study_id