Distant Management of Crohn's Disease by Smartphones is Feasible and Effective Additionally it Reduces the Costs
Primary Purpose
Crohn Disease
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
real time online video visit
Sponsored by
About this trial
This is an interventional health services research trial for Crohn Disease
Eligibility Criteria
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
Sites / Locations
- Kocaeli University Medical Faculty Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard face to face visit
Online visit
Arm Description
This group will receive a traditional outpatient visit
This group will receive a smartphone-based real-time video conference visit
Outcomes
Primary Outcome Measures
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,
Secondary Outcome Measures
Full Information
NCT ID
NCT04754620
First Posted
February 5, 2021
Last Updated
February 12, 2021
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT04754620
Brief Title
Distant Management of Crohn's Disease by Smartphones is Feasible and Effective Additionally it Reduces the Costs
Official Title
Implementation and Evaluation of Smartphone-Based Videoconferance Telehealth for Patients With Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard face to face visit
Arm Type
No Intervention
Arm Description
This group will receive a traditional outpatient visit
Arm Title
Online visit
Arm Type
Experimental
Arm Description
This group will receive a smartphone-based real-time video conference visit
Intervention Type
Other
Intervention Name(s)
real time online video visit
Intervention Description
Participants have received an online visit by a smartphone application
Primary Outcome Measure Information:
Title
Satisfaction score with the video visits
Description
Measurement of satisfaction with RAND Visit Specific Questionnaire (VSQ9),Minimum score "0" poor and maximum score is "5" represents excellent,
Time Frame
the day after the visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
göktuğ şirin
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Study Director
Facility Information:
Facility Name
Kocaeli University Medical Faculty Hospital
City
Izmit
State/Province
Kocaeli
ZIP/Postal Code
41001
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
Data will be available for one year after the study completed
IPD Sharing Access Criteria
Public
Learn more about this trial
Distant Management of Crohn's Disease by Smartphones is Feasible and Effective Additionally it Reduces the Costs
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