Feasibility and Acceptability of an Inflammatory Bowel Disease Self-management Website and Home Faecal Calprotectin Monitoring After Treatment De-escalation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Faecal calprotectin testing completion rates
研究概览
简要总结
6 month exploratory feasibility study to assess if a combination of MyMedicalRecord supported self-management website and a home faecal calprotectin smartphone testing kit is a feasible and acceptable means for patients to monitor for signs of relapse after treatment de-escalation.
详细描述
IBD can be challenging to manage as disease flares are often unpredictable and rarely coincide with scheduled outpatient appointments. Websites are a novel way of assisting patients to take more control over monitoring and managing symptoms and have been shown to improve outcomes in some chronic diseases. The My Medical Record (MyMR) webiste was developed to help patients learn about IBD, access test results, monitor symptoms, and manage their medications, with email support from the IBD team.
The use of home faecal calprotectin monitoring will also be explored. This marker of IBD activity is normally performed in hospital laboratories and becomes elevated before the onset of clinical symptoms of an IBD flare. New technologies enable patients to perform the test at home with the aid of a smartphone application.
A 6 month exploratory feasibility study will be conducted to assess if a combination of MyMR and a home faecal testing kit is a feasible and acceptable means for patients to monitor their illness. Their use will be targeted to patients who have recently stopped (or reduced) a treatment for IBD, as up to 50% of these patients may have a disease flare within a year.
Interventions
- Clinic appointments Study participants will not be required to attend any routine outpatient follow up appointments for the 6 month study period, after which they will be reviewed by a member of the IBD team.
- Questionnaires and interviews Partcipants will receive questionnaires and a sample will also undergo interviews to explore their views regarding the website and stool test.
- Website
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adults aged ≥ 18 years currently under secondary care outpatient follow up for IBD
- •Diagnosed with IBD at least one year prior to study enrolment (to ensure patients are familiar with their disease and treatments)
- •Stopped or reduced the dose of one or more treatments for IBD (for any reason) within the last 8 weeks
- •Able to understand English and provide written consent.
- •Own, or have regular (at least weekly) access to a smartphone +/- personal computer with internet
排除标准
- •Inability to read, understand informed consent
- •Inability to use a smartphone
- •Likely requirement of IBD surgery within the study period
- •Ileostomy
- •Pregnancy or planned pregnancy within next 6 months
- •Terminal illness with limited (< 1year) life expectancy
- •Current participation in another IBD research study
- •Any reason, in the opinion of the investigators, which is likely to make the patient unsuitable for the study
结局指标
主要结局
Faecal calprotectin testing completion rates
时间窗: 6 months
Number of patients completing monthly faecal calprotectin testing
MyMR website usage
时间窗: 6 months
Number of patients logging in to MyMR website at least monthly
次要结局
- IBD-Control(6 months)
- IBD email contact(6 months)
- Calprotectin levels(6 months)
- SIBDQ(6 months)
- Questionnaire response rates(6 months)
- Recruitment(6 months)
- IBD flareline calls(6 months)
- IT support contact(6 months)
- Retention rate(6 months)
- IBD knowledge(6 months)