StoMakker: Improving the Quality of Life of Children Receiving an Ileostomy, Colostomy or Continent Urostomy by Offering Access to a Peer Support Platform, Age Dependent Information Provision and Games in a Smartphone Application
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from baseline in health-related quality of life of participants on the age specific 7 item PROMIS Pediatric Global Health scale (PGH-7) questionnaire at 6 months after surgery
研究概览
简要总结
The goal of this clinical trial is to investigate if access to the StoMakker application will significantly improve health-related quality of life in children receiving surgery resulting in an ileostomy, colostomy or continent urostomy. The main question it aims to answer are:
- Does access to StoMakker improve health-related quality of life in children receiving surgery for an ostomy?
- Does access to StoMakker improve the anxiety and social functioning of children receiving surgery for an ostomy?
- Does access to StoMakker improve postoperative complications of children receiving surgery for an ostomy?
Participants will be asked to fill in several questionnaires around their surgery. The intervention group of the trial will be given access to the application "StoMakker". The control group of the trial will receive standard care.
详细描述
Peer support, patient education and -guidance are of crucial importance for children undergoing surgery for a stoma. Current supportive care is either lacking or via paper folders, which is not a suitable strategy for supporting this vulnerable group of children.
The main objective of this prospective trial is to investigate whether access to a peer support platform, age-dependent information provision and games using a smartphone application increases self-reported health related quality of life (HRQOL).
Study population: Children aged between 6 and 18 years old who will receive an ileostomy, colostomy or continent urostomy, are eligible for inclusion. Participants must have access to a smartphone or tablet. Children who are unable to use a smartphone due to mental or physical disabilities will be excluded from the study
Patients and their parents/caregivers are obliged to give written informed consent before they are allowed to be enrolled in the study.
The design of the study is an open-label multicenter randomized controlled trial with a follow-up of 6 months. The intervention group will get access to the app. The control group will receive standard care. Measurement is done via questionnaires, which are send at specificic intervals based on the surgery date. Parents or caregivers will also receive several questionnaires at specific intervals based on the surgery date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals scheduled for ileostomy, colostomy or continent urostomy surgery
- •Children aged between 6 and 18 years
- •Possession of, or continous access to a smartphone or tablet operated with iOS 9 and up or Android 8.0 and up
- •Access to email and internet
排除标准
- •Incompetence of understanding the Dutch language
- •Visual impairment, unless well corrected with visual aids
- •Physical disabilities limiting the use of a mobile application
- •Mental disabilities limiting the use of a mobile application, learning and filling in questionnaires
- •Patients with pre-existing skin conditions such as pemphigus, para-pemphigus or psoriasis that may disturb or influence normal stoma care protocols
结局指标
主要结局
Change from baseline in health-related quality of life of participants on the age specific 7 item PROMIS Pediatric Global Health scale (PGH-7) questionnaire at 6 months after surgery
时间窗: 6 months follow-up
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health scale (PGH-7) is a validated self reported instrument for assessing general health. Scores range from 5 (low health-related quality of life) to 35 (high health-related quality of life). The questionnaire has been translated to dutch and validated in the Netherlands and dutch speaking Belgium Change = 6 month score - baseline
次要结局
- Change from baseline in anxiety of participants on the age specific 8 item PROMIS pediatric v2.0 Anxiety and Depressive Symptoms, the short form 8a questionnaire at 6 months follow-up(6 months follow-up)
- Change from baseline in social functioning of participants on the age specific PROMIS pediatric item bank peer relationships short form 8a at 6 months after surgery(6 months follow-up)
- Occurrence of any surgery related complications as specified by the clavien-dindo classification within 6 months of follow-up.(6 months follow up)
研究者
Marlies P. Schijven
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)