Impact of Therapeutic Intervention on Quality of Life in Patients With Ulcerative Colitis Depending on the Mucosal Healing Degree
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 10
- 主要终点
- To measure the impact that the therapeutic attitude, based on IBDQ9 and IBD control questionaire, has on the quality of life of patients with UC given a colonoscopy revealing mucosal healing
研究概览
简要总结
This study is therefore postulated as a clear alternative that evaluates patients´quality of life, and recognises fecal calprotectin as an inflammatory marker.
Longitudinal, prospective, multi-center cohort study to measure the impact that the therapeutic attitude (treatment intensification/de-intensification o escalation/de-escalation) has on the quality of life of patients with UC given a colonoscopy revealing mucosal healing (Mayo 0, Mayo 1); considering as treatment intensification/de-intensification a dose increase or decrease on the same line of treatment, and escalation/de-escalation if there is a change to a new line of treatment.
详细描述
Research justification: There is not enough evidence on the effect of therapeutic intervention implemented by doctors in patients with IBD, depending on the rate of mucosal healing at colonoscopy.
From previous studies the investigators know that patients with a Mayo 1 endoscopic score are at a much greater risk for developing a disease outbreak, thus requiring a treatment escalation more frequently than those Mayo 0 patients. Then, it is needed a study of real clinical practice to evaluate the efficacy of this therapeutic intervention (same treatment or escalation/de-escalation strategy) in patients' quality of life.
Objectives:
Primary:
- After 6 and 12 months, to measure the impact that the therapeutic attitude (treatment intensification/de-intensification o escalation/de-escalation) has on the quality of life of patients with UC given a colonoscopy revealing mucosal healing (Mayo 0, Mayo 1); considering as treatment intensification/de-intensification a dose increase or decrease on the same line of treatment, and escalation/de-escalation if there is a change to a new line of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •UC diagnosed.
- •Signed and dated informed consent form.
- •Have undergone a Mayo 0 or 1 endoscopic score colonoscopy while in clinical remission.
排除标准
- •Incomplete colonoscopy.
- •Previous bowel resection.
- •Ostomy patient.
- •Active infection.
- •Pregnancy.
- •Lack of patient's informed consent.
结局指标
主要结局
To measure the impact that the therapeutic attitude, based on IBDQ9 and IBD control questionaire, has on the quality of life of patients with UC given a colonoscopy revealing mucosal healing
时间窗: at 6 and 12 months
After 6 and 12 months, to measure the impact that the therapeutic attitude (treatment intensification/de-intensification o escalation/de-escalation) has on the quality of life of patients with UC given a colonoscopy revealing mucosal healing (Mayo 0, Mayo 1); considering as treatment intensification/de-intensification a dose increase or decrease on the same line of treatment, and escalation/de-escalation if there is a change to a new line of treatment.
次要结局
- Outbreak risk assessment depending on the intervention developed(at 6 and 12 months)
- To evaluate the impact of inflammatory markers(at 6 and 12 months)