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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.
Full description
Number of volunteers: 64 patients with IBD Study duration: 18 months (12 months - patient enrollment, 6 months - telemonitoring).
Inclusion criteria:
Exclusion criteria:
Outpatient observation with connection to the telemonitoring program - 32 participants.
Outpatient monitoring without connecting to the telemonitoring program - 32 participants.
Study design:
Stage 1: All patients will undergo laboratory tests (including general blood test, C-reactive protein, fecal calprotectin) and instrumental examinations (colonoscopy with biopsy). Computed tomography of the abdomen and pelvis with contrast or magnetic resonance enterography for patients with severe IBD or jejunoileitis will be performed.
After group assignment and signing informed consent, all participants will fill out the following questionnaires:
Clinical activity of the disease will be measured by Ulcerative Colitis Disease Activity Index (UCDAI) for ulcerative colitis and Crohn's Disease Activity Index (CDAI) for Crohn disease.
All patients will be screened for anxiety, depression, alexithymia and visceral hypersensitivity. A psychiatrist will interview patients with changes in psychological well-being or signs of psychiatric disorders.
Stage 2: Control group patients will receive one face-to-face appointment with gastroenterologist, who will give them recommendations on treatment, surveillance and diet. The standard care for control group will be provided according to the evidence-based guidelines with visits on patient's request.
Telemonitoring group patients will receive authorized access to the personal account on the web platform. The platform contains educational information about IBD, necessary lifestyle changes and dietary recommendations based on international guidelines and education material from Crohn's and Colitis Foundation.
Patients will have to log in to the web platform at least once a month. When the patient logs in to the telemedicine platform they will have to fill out the following data: 1) SCCAI for Ulcerative colitis and Harvey-Bradshaw index for Crohn disease to evaluate clinical activity of the disease during the monitoring; 2) IBD disk questionnaire to evaluate disease dynamics; 3) results of laboratory tests (general blood test, C-reactive protein, fecal calprotectin).
The results of the tests will be available to the health care professionals and the patients. The patients will also have an option of online consultation with a gastroenterologist upon request via chat or phone call. The patients will be instructed to contact a gastroenterologist if they have a recurrence of the disease.
Gastroenterologists will make a phone call to each patient from intervention group with questioning according to the checklist every month. The gastroenterologists will be instructed to provide emergency response in case of critical deviation of health indicators from the limit values or occurrence of complaints indicating the development of an acute condition.
Stage 3: Participants from both groups will be re-hospitalized after 6 months of monitoring. We will evaluate IBD activity according to laboratory and instrumental examinations including general blood tests, C-reactive protein, fecal calprotectin, colonoscopy with biopsy, computed tomography or MR-enterography (for patients with severe IBD or jejunoileitis). Both groups will also have to recomplete all questionnaires to evaluate the study endpoints.
The purpose of this study is to evaluate telemedicine impact in IBD.
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Inclusion and exclusion criteria
IInclusion criteria:
Exclusion criteria:
Primary purpose
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62 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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