Telephone Consultation as a Substitute for Routine Out-patient Face-to-face Consultation for Children With Inflammatory Bowel Disease: Randomised Controlled Trial and Economic Evaluation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Changes in the paediatric IBD-specific health-related quality of life (QOL) scores.
研究概览
简要总结
Inflammatory bowel disease (IBD) refers to two chronic diseases (Crohn's disease and ulcerative colitis) that affect the intestines. The number of new cases of IBD in people younger than 16 years old has been increasing in the United Kingdom (UK), and is currently estimated to be 700 new cases every year. There is no cure for IBD and patients experience episodes of flareups in between periods of wellbeing.
Traditionally, children with IBD are asked to attend regular hospital appointments. This means that, even if they are well, they have to get to the hospital and this can involve travelling long distances.
Telephone consultations have been shown to be beneficial in some areas of medicine but this approach has not been well studied in children. The aims of this study are to determine whether telephone consultations would improve quality of life, patient satisfaction, proportion of consultations attended and whether they would be safe and reduce costs for patients and the National Health Service (NHS). Investigators plan a randomised controlled trial involving 92 participants recruited from amongst the 250 children and adolescents aged between 8 and 16 years who attend the regional paediatric IBD centre in Manchester. Half will be assigned to telephone consultations, and half to face to face consultations. The study would have the approval of the local ethics committee and participants would have provided written consent. Investigators will compare outcomes in the two groups over 2 years. If telephone consultations prove to be effective, the NHS could offer children with IBD the choice of either telephone consultation or face to face consultation for their outpatient followup. Those who are doing well would not have to make unnecessary journeys to the hospital. This would free up clinic spaces and allow patients who are unwell, and new patients to be seen more quickly, thus reducing waiting
详细描述
HYPOTHESIS Telephone consultation is effective, safe, and a cost-effective alternative to traditional routine face-to-face consultation for children and adolescents with IBD.
AIMS
The specific aims of the study are:
- To determine if telephone consultation, compared to face-to-face consultation is effective for children and adolescents with IBD.
The investigators hypothesise that compared to face-face-consultations, telephone consultations would:
- improve patients' health-related quality of life
- have a positive impact on patient/carer satisfaction with consultations
- reduce out-patient non-attendance rate
- To determine any adverse events associated with routine telephone consultations in children and adolescents with IBD.
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
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged between 8 and 16 years
- •diagnosis of IBD by established clinical, endoscopic, histological and radiological criteria
- •clinical remission defined as an abbreviated Paediatric Crohn's Disease Activity Index (aPCDAI) score of ≤10 for patients with Crohn's disease or as a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of <10 for those with ulcerative colitis and indeterminate colitis
- •parental and child's consent to participate in the study.
排除标准
- •active disease (aPCDAI>15 or PUCAI ≥15)
- •unwillingness to provide informed consent.
结局指标
主要结局
Changes in the paediatric IBD-specific health-related quality of life (QOL) scores.
时间窗: 6 monthly over 2 years
QOL scores will be assessed at baseline, and 6-monthly over the 2-year follow-up period using the validated paediatric IBD QOL IMPACT questionnaire
次要结局
- Relapses(All relapses over 2 years)