Status:
ENROLLING_BY_INVITATION
Telemonitoring for IBD Goodness Examination in Russia
Lead Sponsor:
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Collaborating Sponsors:
Sechenov University
Conditions:
Inflammatory Bowel Diseases
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, randomized study to assess the impact of telemedicine (telemonitoring, tele-education and tele-consultation) on the patients with Inflammatory Bowel Disease (IBD). The main stud...
Detailed Description
Number of volunteers: 64 patients with IBD Study duration: 18 months (12 months - patient enrollment, 6 months - telemonitoring). Inclusion criteria: * Age ≥18 years old. * Signed informed consent. ...
Eligibility Criteria
Inclusion
- IInclusion criteria:
- Age ≥18 years old.
- Signed informed consent.
- Diagnosis: Crohn disease (ICD-10 codes K50.0, K50.1, K50.8, K50.9) and Ulcerative colitis (K51.0, K51.2, 51.3, K51.5, K51.8);
- Treatment in the Gastroenterology Department in Sechenov University Hospital at the moment of trial start.
- Exclusion criteria:
- Severe cognitive dysfunction;
- Acute mental illness;
- Lack of technical ability to take part in telemedical intervention (does not have the skills to work with a smartphone, computer, tablet, there is no appropriate technical means);
- Participation in other clinical studies.
- Oncological diseases requiring active treatment.
- Patients who denied signing informed consent.
- Severe decompensation of cogent comorbid ailment;
- Inability to understand written Russian;
- Pregnant individuals.
Exclusion
Key Trial Info
Start Date :
April 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05994716
Start Date
April 25 2023
End Date
October 30 2024
Last Update
February 7 2024
Active Locations (1)
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Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Moscow, Russia