Clinical trial NCT04064541: Virtual Visits to Optimize Research Trial Offerings to HF Patients
Official title: Virtual Visits and Distance Health to Optimize Research Trial Offerings to Heart Failure Patients: An Innovative Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Systolic
Heart Failure With Preserved Ejection Fraction
Keywords: Heart Failure
Distance Health
Virtual Visits
Functional Assessment
Quality of Life
Cognitive Assessment
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects in this study will serve as their own control in order to assess their ability to perform functional, cognitive and QOL assessments in the virtual/ distance health environment.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Patient's ability to complete the American Thoracic Society 6-minute walk test functional assessment via a virtual visit at Day 7 as compared to completing the same baseline test in the outpatient clinic.
timeFrame: Day 7
measure: Patient's ability to complete the American Thoracic Society 6-minute walk test functional assessment via a virtual visit at Day 14 as compared to completing the same baseline test in the outpatient clinic.
timeFrame: Day 14
measure: Patient's ability to complete the Timed Up and Go functional assessment test via virtual visit at Day 7 as compared to completing the same baseline test in the outpatient clinic.
timeFrame: Day 7
measure: Patient's ability to complete the Timed Up and Go functional assessment test via virtual visit at Day 14 as compared to completing the same baseline test in the outpatient clinic.
timeFrame: Day 14
measure: Patient's ability to complete the Kansas City Cardiomyopathy Quality of Life Questionnaire (KCCQ) per virtual visit at Day 7 as compared to completing the same baseline test in the outpatient clinic.
timeFrame: Day 7
measure: Patient's ability to complete the Kansas City Cardiomyopathy Quality of Life Questionnaire (KCCQ) per virtual visit at Day 14 as compared to completing the same baseline test in the outpatient clinic.
timeFrame: Day 14
measure: Patient's ability to complete the Frailty Index for Elders (FIFE) questionnaire per virtual visit at Day 7 as compared to completing the same baseline test in the outpatient clinic.
timeFrame: Day 7
measure: Patient's ability to complete the Frailty Index for Elders (FIFE) questionnaire per virtual visit at Day 14 as compared to completing the same baseline test in the outpatient clinic.
timeFrame: Day 14
measure: Patient's ability to complete the European Quality Of Life-5Dimension-5Level (EQ-5D-5L) Health State Questionnaire per virtual visit at Day 7 as compared to completing the same baseline test in the outpatient clinic.
timeFrame: Day 7
measure: Patient's ability to complete the European Quality Of Life-5Dimension-5Level (EQ-5D-5L) Health State Questionnaire per virtual visit at Day 14 as compared to completing the same baseline test in the outpatient clinic.
timeFrame: Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Laurie Ann Moennich, MPH CPH
role: PRINCIPAL_INVESTIGATOR
References: