Telemonitoring for IBD Goodness Examination in Russia

NCT05994716 | Enrolling By Invitation

• 1 other identifier: 2023-1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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 study objective is to evaluate the impact of telemedicine on the quality of life in IBD. The secondary study endpoints are to determine disease activity, the number of IBD relapses, to investigate rate of leukopenia in patients taking azathioprine, to determine medication adherence, psychological well-being and satisfaction with medical care in the telemedicine group in comparison with the face-to-face follow-up group. Moreover, we aim to evaluate association between secondary outcomes and QoL. It is planned to enroll 64 patients. The study duration is 18 months (12 months - patient enrollment, 6 months - telemonitoring). The study consists of 3 stages. The first stage is selection of patients with IBD after treatment in the gastroenterology department. The second stage is face-to-face appointment and general recommendations (for the observation group); monthly completion of questionnaires on the web-platform, possibility to contact with doctor via chat or phone call, access to educational information; a monthly phone call to each patient from to answer any questions or concerns they may have and to interview them according to the checklist (for the intervention group). The third stage is the evaluation of IBD activity (re-hospitalization after 6 months), number of IBD relapses, quality of life, frequency of leukopenia in patients receiving azathioprine therapy, medication adherence, psychological well-being and satisfaction with medical care.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Keywords

Inflammatory Bowel Disease; Telemedicine; Telemonitoring

Outcome Measures

Primary Outcomes (1)

• Change the Health-related quality of life in IBD

  Change the quality of life in IBD according to Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Max score is 70, min score is 10. \< 50 means poor HRQol; \>50 optimal HRQol Higher score means better outcome

  Upon completion, up to 6 months

Secondary Outcomes (9)

• Change clinical activity of Crohn Disease (CD)

  Upon completion, up to 6 months

• Change clinical activity of Ulcerative Colitis (UC)

  Upon completion, up to 6 months

• Change General medication adherence

  Upon completion, up to 6 months

• Change rate of leukopenia in patients taking azathioprine

  Upon completion, up to 6 months

• Change Satisfaction with medical care

  Upon completion, up to 6 months

Other Outcomes (7)

• To determine Endoscopic activity of UC

  Upon completion, up to 6 months

• To determine Endoscopic activity of CD

  Upon completion, up to 6 months

• To determine Histological activity of IBD

  Upon completion, up to 6 months

Study Arms (2)

Observation group

NO INTERVENTION

Telemonitoring

EXPERIMENTAL

Other: Telemonitoring

Interventions

Telemonitoring OTHER

A) Monthly completion data on the web platform: 1) SCCAI for Ulcerative colitis and Harvey-Bradshaw index for Crohn disease. 2) IBD disk questionnaire to evaluate disease dynamics. 3) General blood test. B) Possibility of online consultation with a gastroenterologist upon request via chat or phone call. C) Access to educational information about IBD, necessary lifestyle changes, dietary recommendations; D) monthly phone call will be made to each patient from the intervention group to answer any questions or concerns they may have and to interview them according to the checklist.

Telemonitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department: lead
• Sechenov University: collaborator

Study Sites (1)

Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

Moscow, Russia

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Yuliya F Shumskaya

  Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

  PRINCIPAL INVESTIGATOR

• Anton V Vladzymyrskyy, PhD

  Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 16, 2023
• Study Start: April 25, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)