NCT03947905

Brief Summary

The aim of the current study is to compare virtual clinic visits (i.e., real-time, face-to-face visits conducted over the internet with tablet devices) to actual physical clinic visits. After both types of visits (virtual versus physical) physicians will be asked to classify patients into low, moderate or high risk for a vascular intervention. It is hypothesized that there will be good agreement between classifications made after the virtual visits as compared to those made after physical visits. That is, virtual visit classifications will be as good as those made after physical visits.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

April 12, 2019

Last Update Submit

March 24, 2026

Conditions

Keywords

VascularClinic visitTele-health

Outcome Measures

Primary Outcomes (1)

  • Categorization of physician treatment plans. (Physicians will classify treatment plans as low, moderate or high need for vascular intervention)

    Comparison of virtual visit treatment plans to physical treatment plans. After assessments, physicians will classify patients' treatment plans into low (treat medically), moderate (vascular intervention in the future, but not immediately) or high (needs immediately, within 2 weeks). The distribution of low, moderate and high among the two types of visits (Virtual and Physical) will be compared.

    1 week

Secondary Outcomes (1)

  • Patient satisfaction

    1 week

Study Arms (1)

Type of visit

EXPERIMENTAL

Single arm, non-randomized crossover design. All patients will receive both types of visits virtual and physical, and after assessments are made, participants will be classified by physicians into low, moderate or high risk for intervention.

Procedure: Virtual visit

Interventions

Virtual visitPROCEDURE

Type of visit

Also known as: Physical visit
Type of visit

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred to and scheduled for an initial visit at our Vascular Center of Excellence (VCOE).

You may not qualify if:

  • Patients that are deemed urgent cases by the VCOE, and scheduled within two weeks for the initial clinic visit.
  • Patients who are scheduled to have the placement of an arteriovenous (AV) fistula at the time of the initial clinic visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAMC Health Education and Research Institute

Charleston, West Virginia, 25304, United States

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Open label
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Single arm crossover design where all participants receive both types of visits (Virtual and Physical visits).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2019

First Posted

May 13, 2019

Study Start

April 4, 2019

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations