Telemonitoring for IBD Goodness Examination in Russia

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

Interventions

OTHER

Telemonitoring

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.

Sponsors & Collaborators

• Sechenov University

  collaborator OTHER

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

  lead OTHER

Principal Investigators

• Yuliya F Shumskaya · Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

• Anton V Vladzymyrskyy, PhD · Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-25

Primary Completion

2024-10-30

Completion

2024-10-30

Countries

• Russia

Study Locations