Effectiveness of Telemedicine in Inflammatory Bowel Disease

Study Overview
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Brief Summary
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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 minimize adverse drug reactions, to reduce the number of IBD relapses, to improve medication adherence, to improve satisfaction with medical care, to minimize the use of healthcare resources. It is planned to enroll 60 patients. The study duration is 1 year (6 months - patient enrollment, 6 months - telemedical intervention). 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 (for the intervention group). The third stage is the evaluation of IBD activity (re-hospitalization after 6 months), psychological well-being, quality of life, medication adherence, etc.

Detailed Description
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Number of volunteers: 60 patients with IBD Study duration: 1 year (6 months - patient enrollment, 6 months - telemedical intervention). 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). 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. Outpatient observation with connection to the telemonitoring program - 30 participants. Outpatient monitoring without connecting to the telemonitoring program - 30 participants. Study design: Stage 1: selection of the patients with IBD that meet the inclusion criteria after inpatient treatment in the gastroenterology department. Randomization of participants into two groups: face-to-face outpatient observation and observation using telemedicine technologies. Signing informed consent, filling out questionnaires: Simple Clinical Colitis Activity Index (SCCAI) questionnaire for patients with ulcerative colitis / Harvey-Bradshaw index (HBI) questionnaire for patients with Crohn disease; World Health Organization's Quality of Life (WHOQOL-26): questionnaire for assessing health-related quality of life; SIBDQ: Short Inflammatory Bowel Disease Questionnaire; Work Productivity and Activity Impairment Questionnaire (WPAI): questionnaire used to evaluate work productivity and activity impairment; Hospital Anxiety and Depression Scale (HADS); Toronto Alexithymia Scale (TAS-26): used to evaluate alexithymia (a risk factor for the development of psychosomatic diseases); Visceral Sensitivity Index (VSI): Special gastroenterological questionnaire to determine the index of visceral sensitivity; PSQ-18: Patient Satisfaction Questionnaire; General Medication Adherence Scale (GMAS) to determine the adherence to the therapy. Stage 2: for the outpatient observation group: one face-to-face appointment, general recommendations. For the telemonitoring group patients log in to the web platform at least once a month. When the patient log in to the telemedicine platform the following scorings must be filled out:1) SCCAI for Ulcerative colitis and Harvey-Bradshaw index for Crohn disease. 2) IBD disk questionnaire to evaluate disease dynamics. The results of the scoring systems will appear to the health care professionals and patients in a traffic light manner (red, yellow and green). If patient has a recurrence of the disease, he will be instructed to contact a doctor. Patients from intervention group will have the possibility of online consultation with a gastroenterologist upon request via chat or phone call and access to educational information about IBD, necessary lifestyle changes, dietary recommendations. To be assessed in both groups during the entire observation period: Frequency of scheduled and unscheduled visits, hospitalizations in medical organizations, assistance within the statutory health insurance system; The number of surgical interventions associated with IBD; Activity impairment and work productivity; Mortality from complications of IBD; State and patient spending on healthcare; Stage 3: re-hospitalization of both groups 6 months after randomization in order to evaluate IBD activity (laboratory and instrumental examinations). Re-completion of all questionnaires for both groups. The purpose of this study is to evaluate telemedicine impact in IBD.

Official Title
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Effectiveness of Telemedicine in Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis

Intervention / Treatment
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* Other: Telemedical intervention


Participation Criteria
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Eligibility Criteria
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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). 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observation group<br> | |
| Experimental: Telemedical intervention group<br> | Other: Telemedical intervention<br>* A) Monthly completion of questionnaires on the web platform: 1) SCCAI for Ulcerative colitis and Harvey-Bradshaw index for Crohn disease. 2) IBD disk questionnaire to evaluate disease dynamics. 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change the quality of life in IBD measured by SIBDQ | Change the quality of life in IBD according to Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Max value is 70, min value is 10. Value less than 50 means poor heath related quality of life. Higher score means better outcome. | Upon completion, up to 6 months | 
| Change the quality of life in IBD measured by WHOQOL-26 | Change the quality of life in IBD according to World Health Organization's Quality of Life (WHOQOL-26) questionnaire. Higher score means better outcome. | Upon completion, up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintaining/achieving clinical remission of Crohn Disease | Clinical remission of Crohn Disease will be measured by Harvey-Bradshaw Index (HBI) questionnaire. Lower score means better outcome. | Upon completion, up to 6 months | 
| Maintaining/achieving clinical remission of Ulcerative Colitis | Clinical remission of Ulcerative will be measured by Colitis Simple Clinical Colitis Activity Index (SCCAI) questionnaire. Lower score means better outcome. | Upon completion, up to 6 months | 
| Maintaining/achieving clinical remission of IBD | Clinical remission of IBD will be measured by Inflammatory Bowel Disease disk (IBD disk) questionnaire. Higher score means better outcome. | Upon completion, up to 6 months | 
| Maintaining/achieving endoscopic remission of IBD | Endoscopic remission of IBD will be measured by colonoscopy. | Upon completion, up to 6 months | 
| Maintaining/achieving histological remission of IBD | Histological remission of IBD will be measured via biopsy | Upon completion, up to 6 months | 
| Change the number adverse drug reactions in IBD | Change the number adverse drug reactions in IBD | Upon completion, up to 6 months | 
| Change satisfaction with treatment of patients with IBD | Change satisfaction with treatment of patients with IBD according to Patient Satisfaction Questionnaire (PSQ-18). Max value is 90, min value is 18. Higher score means better outcome. | Upon completion, up to 6 months | 
| Change psychological well-being of patients with IBD measured by HADS | Change psychological well-being of patients with IBD according to Hospital Anxiety and Depression Scale (HADS). Each item is scored on a response-scale with four alternatives ranging between 0 and 3. Score 8-10 for doubtful cases and ≥11 for definite cases of depression and anxiety. | Upon completion, up to 6 months | 
| Change psychological well-being of patients with IBD measured by VSI | Change psychological well-being of patients with IBD according to Visceral Sensitivity Index (VSI). Min value is 0, max value is 75. Lower score means better outcome. Score from 31 to 75 means visceral hypersensitivity. | Upon completion, up to 6 months | 
| Change psychological well-being of patients with IBD measured by TAS-26 | Change psychological well-being of patients with IBD according to Toronto Alexithymia Scale (TAS-26) questionnaire. Min value 26, max value 130. Score higher than 63 means worse outcome. | Upon completion, up to 6 months | 
| Change the number of surgical interventions in IBD | Evaluation of the use of surgical interventions | Upon completion, up to 6 months | 
| Change the number of hospitalizations in IBD | Evaluation of the number of hospitalizations | Upon completion, up to 6 months | 
| Change the number of outpatient visits in IBD | Evaluation of the number of outpatient visits | Upon completion, up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Disease, Telemedicine, Telemonitoring