Impact of Telemonitoring in the Management of Complex Inflammatory Bowel Disease in Spain: TECCU Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 30
- 主要终点
- clinical remission
研究概览
简要总结
M-TECCU is a study: multicenter, randomized and open. It consists of two parallel groups to compare the efficacy of the TECCU web-based telemonitoring system to achieve and maintain activity remission in patients with moderate-high complexity inflammatory bowel disease compared to usual clinical practice.
详细描述
Clinical trial with an open, randomized and controlled non-inferiority medical device, in which the impact of a follow-up method through a web telemonitoring platform on the time in clinical remission of patients with complex IBD is evaluated, in comparison with the usual follow-up in outpatient clinics.
Patients with complex IBD are considered to be those who receive treatment with immunosuppressants or biological therapies to control the luminal activity of their disease. Patients carry out periodic controls for the disease according to a pre-established schedule based on national and international clinical guidelines. The patients in the telemonitoring group (G_TECCU) follow these controls through the TECCU platform, a web system that allows them to fill in questionnaires related to the clinical variables under study and communicate freely with healthcare personnel during pre-established controls and when the patient deems it necessary. On the other hand, the patients of the control group (G_Control) carry out the controls according to the same schedule as G_TECCU, but following the usual clinical practice.
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
- None
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
- •Patients ≥18a
- •IBD (CD or UC) diagnosed according to ECCO criteria
- •Start treatment with immunosuppressants and/or biological therapies due to luminal activity
- •signed informed consent
排除标准
- •Pregnant women
- •Presence of active perianal disease, ileoanal reservoir, or definitive stoma
- •Patients with mental illness or other poorly controlled illness
- •Patients with active cancer diagnosis
- •Terminal patients and/or palliative care (SECPAL)
- •Family members of the research team
- •Patients without a telephone line to connect with a mobile, tablet and/or computer / Inability to drive
- •Cognitive or linguistic difficulties
- •Patients included in another experimental study
研究组 & 干预措施
Control group
Patients receive conventional care in the outpatient clinics of the participating specialized IBD units in Spain. This is complemented with telephone controls for those aspects that can be controlled by this means according to standard clinical practice. Likewise, an individual assessment will be made if, after the situation generated by SARS-COV2, any participating center should have to modify face-to-face consultations for telephone consultations, following the usual clinical practice at all times.
Web telemonitoring group (G_TECCU)
Monitoring and control will be done remotely through the TECCU comprehensive management platform, configured to respond to the specific needs of IBD patients. Patients will connect to the internet from a computer or an APP application on a tablet or mobile terminal, Android or iOS. They will have to complete questionnaires related to the variables under study at each control according to a pre-established follow-up plan. During the follow-up, the number of controls may be increased (intensive monitoring) according to the evolution of the patient, who in turn will be able to perform controls on demand. The healthcare personnel of each IBD unit will receive the information of each patient filtered through an intelligent alert generation system from which an integrated intervention protocol will be followed to adjust the treatment and follow-up plan in each case.
干预措施: TECCU Software (Other)
结局指标
主要结局
clinical remission
时间窗: 52 weeks
To compare the time in remission of patients with complex IBD (require immunosuppressants and/or biologics to control their luminal inflammatory activity) controlled with the TECCU intervention (G\_TECCU) with respect to usual clinical practice (G\_Control) after 52 weeks of follow-up.
次要结局
- cost-effectiveness(52 weeks)