Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- to evaluate mental stress/health as an impacting factor on UC progression
研究概览
简要总结
The project aims to implement the Internet Of Thing (IoT) platform of the San Raffaele Hospital (OSR) with data from stress conditions perceived by the patient through the synergistic collaboration between patients, gastroenterologists and psychologists.
详细描述
This is a prospective, single-center observational study involving patients with an established diagnosis of UC who are currently receiving standard care and eligible for advanced therapies at the San Raffaele Hospital (OSR).
The estimated sample size for the 1-year project is 150 UC patients eligible for advanced therapy.
This study aims to understand the relationship between environmental factors, dietary composition, and altered intestinal permeability that contribute to flares in UC patients by leveraging Internet-Of-Things (IoT) technologies.
These subjects will be asked to answer a series of questions about feelings and thoughts via the mobile app each month.
The mobile app was developed and designed following the open source ResearchKit framework.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in whom the ulcerative colitis has been diagnosed and eligible for advanced therapies Patients will be asked to sign an informed consensus before filling out the questionnaire.
排除标准
- •Patients in whom the ulcerative colitis has not been diagnosed. All those who have not signed previously informed consensus.
结局指标
主要结局
to evaluate mental stress/health as an impacting factor on UC progression
时间窗: 8 months
The enrolled UC patients should compile a questionnaire which asks about feelings and thoughts. The questionnaire will be the Italian version of the Perceived Stress Scale (PSS). The scale goes from 0 to 4.Scoring is reversed for positive questions 0= 4 scores; 1= 3 scores, 2=2 scores; 3=1 score; 4=0. For negative questions are 0 minimum score and 4 maximum score Higher score is considered more stress, so worse outcome, conversely lower score is less stress so better outcome. Patients will be remembered to answer to questions about their habits though a notification every 30 days in mobile app.
次要结局
未报告次要终点
研究者
Silvio Danese
Professore
IRCCS San Raffaele