NCT04754620

Brief Summary

Evaluation of the feasibility, acceptability, patient satisfaction and economic benefits of smartphone video-based telehealth in the management of Crohn's disease patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

February 5, 2021

Last Update Submit

February 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Satisfaction score with the video visits

    Measurement of satisfaction with RAND Visit Specific Questionnaire (VSQ9),Minimum score "0" poor and maximum score is "5" represents excellent,

    the day after the visit

Study Arms (2)

Standard face to face visit

NO INTERVENTION

This group will receive a traditional outpatient visit

Online visit

EXPERIMENTAL

This group will receive a smartphone-based real-time video conference visit

Other: real time online video visit

Interventions

Participants have received an online visit by a smartphone application

Online visit

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study group included patients with documented Crohn's disease, based on clinical, endoscopic, and histologic findings
  • Patient between 18-80 years old
  • Participants who have been receiving treatment for more than six months

You may not qualify if:

  • Patients were excluded from the study if they had no internet connection
  • Unable to use smartphones because of blindness, deafness, or mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Medical Faculty Hospital

İzmit, Kocaeli, 41001, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • göktuğ şirin

    Kocaeli University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 15, 2021

Study Start

March 1, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share
Shared Documents
ANALYTIC CODE
Time Frame
Data will be available for one year after the study completed
Access Criteria
Public

Locations