- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04754620
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
-
-
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
|
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
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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