Effectiveness of Telemedicine in Inflammatory Bowel Disease in Russia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change the Health-related quality of life in IBD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change the Health-related quality of life in IBD
时间窗: Upon completion, up to 6 months
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
次要结局
- 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 psychological well-being of patients with IBD measured by HADS(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)
- Change the quality of life in IBD measured by WHOQOL-26(Upon completion, up to 6 months)
- Change psychological well-being of patients with IBD measured by VSI(Upon completion, up to 6 months)
- Change General medication adherence(Upon completion, up to 6 months)
- Change psychological well-being of patients with IBD measured by TAS-26(Upon completion, up to 6 months)