Israeli IBD Research Nucleus (IIRN) Consortium: COBMINDEX Goes Forward- A Smartphone Application for Added Psychological Wellbeing in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Effectiveness of application as compared to human therapist.
研究概览
简要总结
Psychological intervention by COBMINDEX application to reduce psychological stress among CD patients, fatigue and pain and improve the patients' well being, quality-of-life and disease-coping skills, as well as improvement of the patients' immunological profile and intestinal microbiome.
详细描述
200 patients will be randomly divided into two groups - 100 patients will learn and practice COBMINDEX by a human therapist-social worker and 100 patients will learn and practice COBMINDEX by a digital therapist using the COBMINDEX application.
In the first 3-months there will be an assessment of patient progress following randomization to human therapist or digital therapist using the application for learning and practicing. During this period, the group of the human social-worker will have a limited access to the application dedicated for daily exercises and assessment.
In the following 9-month period, all patients will practice using the application, each group by it's permissions.
There will be daily assessment of stress, pain, fatigue, well-being and frequent assessments of patients' medical, psychological, and immunological status.
Throughout the trial, adverse events and concomitant medications will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to participate and signed informed consent
- •Hebrew-speaking
- •Age 18-75
- •Proven diagnosis of Crohn's disease, at least 3 months post-diagnosis
- •Stable medical treatment for the last 3 months
- •Any Harvey Bradshaw Index score
- •Ability to operate a smartphone and cellular application
排除标准
- •Diagnosis of ulcerative colitis or unclassified inflammatory bowel disease
- •Planned surgery for Crohn's disease
- •Surgery for Crohn's disease (excluding drainage of perianal abscess) in the last 3 months
- •Psychiatric disease (schizophrenia, major depression or bipolar disorder)
- •Alcohol or drug dependency (stable medical use of cannabinoids will be allowed)
- •Pregnancy or planned pregnancy during study period
- •Clinically significant comorbidity
- •Former participation in COBMINDEX trials
结局指标
主要结局
Effectiveness of application as compared to human therapist.
时间窗: 12 months
Develop a smartphone application that will teach the patient COBMINDEX and to determine whether the application will be as effective as the psychological intervention delivered by the therapists. the primary end point is SIBDQ disease specific HRQOL. 10 questions each scale 1-7 with range 7-70. higher is better.
次要结局
- disease severity measurement(12 months)
- Effects of intervention on microbiome(12 months)
- Cost-effectiveness(12 months)
- Psychological improvment(12 months)
研究者
Dr Doron Schwartz
Senior Physician, Department of Gastroenterology and Hepatology
Soroka University Medical Center