Clinical trial NCT05994716: Telemonitoring for IBD Goodness Examination in Russia
Official title: Effectiveness of Telemedicine in Inflammatory Bowel Disease in Russia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Keywords: Inflammatory Bowel Disease
Telemedicine
Telemonitoring
Lead sponsor: Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Sponsor class: OTHER
Collaborators: name: Sechenov University
First posted: 2023-08-16
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.
* 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.

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:

1. Simple Clinical Colitis Activity Index (SCCAI) questionnaire for patients with ulcerative colitis / Harvey-Bradshaw index (HBI) questionnaire for patients with Crohn disease;
2. World Health Organization's Quality of Life (WHOQOL-26): questionnaire for assessing health-related quality of life;
3. SIBDQ: Short Inflammatory Bowel Disease Questionnaire;
4. Hospital Anxiety and Depression Scale (HADS);
5. Toronto Alexithymia Scale (TAS-26): used to evaluate alexithymia (a risk factor for the development of psychosomatic diseases);
6. Visceral Sensitivity Index (VSI): Special gastroenterological questionnaire to determine the index of visceral sensitivity;
7. PSQ-18: Patient Satisfaction Questionnaire;
8. General Medication Adherence Scale (GMAS) to determine the adherence to the therapy.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change the Health-related quality of life in IBD
timeFrame: Upon completion, up to 6 months
Secondary outcomes:
measure: Change clinical activity of Crohn Disease (CD)
timeFrame: Upon completion, up to 6 months
measure: Change clinical activity of Ulcerative Colitis (UC)
timeFrame: Upon completion, up to 6 months
measure: Change General medication adherence
timeFrame: Upon completion, up to 6 months
measure: Change rate of leukopenia in patients taking azathioprine
timeFrame: Upon completion, up to 6 months
measure: Change Satisfaction with medical care
timeFrame: Upon completion, up to 6 months
measure: Change psychological well-being of patients with IBD measured by HADS
timeFrame: Upon completion, up to 6 months
measure: Change psychological well-being of patients with IBD measured by VSI
timeFrame: Upon completion, up to 6 months
measure: Change psychological well-being of patients with IBD measured by TAS-26
timeFrame: Upon completion, up to 6 months
measure: Change the quality of life in IBD measured by WHOQOL-26
timeFrame: Upon completion, up to 6 months
Other outcomes:
measure: To determine Endoscopic activity of UC
timeFrame: Upon completion, up to 6 months
measure: To determine Endoscopic activity of CD
timeFrame: Upon completion, up to 6 months
measure: To determine Histological activity of IBD
timeFrame: Upon completion, up to 6 months
measure: General medication adherence differences
timeFrame: Upon completion, up to 6 months
measure: Change the number of non-scheduled medical encounters
timeFrame: Upon completion, up to 6 months
measure: Change the number of surgical interventions
timeFrame: Upon completion, up to 6 months
measure: Change the number of of hospitalizations
timeFrame: Upon completion, up to 6 months
Locations:
city: Moscow
country: Russian Federation
facility: Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Study officials:
affiliation: Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
name: Yuliya F Shumskaya
role: PRINCIPAL_INVESTIGATOR
affiliation: Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
name: Anton V Vladzymyrskyy, PhD
role: STUDY_DIRECTOR
References: