Distant Management of Crohn's Disease by Smartphones is Feasible and Effective Additionally it Reduces the Costs

February 12, 2021 updated by: Hasan Yılmaz, Kocaeli University

Implementation and Evaluation of Smartphone-Based Videoconferance Telehealth for Patients With Crohn's Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients were examined by two gastroenterologists (HY, AED) either at a video conference based visit or face to face visit in outpatients clinics. We used the WhatsApp business application.The online visit notion was the same as traditional face-to-face visit except physical examination.

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kocaeli
      • Izmit, Kocaeli, Turkey, 41001
        • Kocaeli University Medical Faculty Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard face to face visit
This group will receive a traditional outpatient visit
Experimental: Online visit
This group will receive a smartphone-based real-time video conference visit
Other: real time online video visit
Participants have received an online visit by a smartphone application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction score with the video visits
Time Frame: the day after the visit
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Study Director: göktuğ şirin, Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KouTeleH001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

Data will be available for one year after the study completed

IPD Sharing Access Criteria

Public

IPD Sharing Supporting Information Type

  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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