Generation and Evaluation of Hand Therapy Devices for Epidermolysis Bullosa (GLOVE Project): Proof of Concept Study for a Dressing Glove
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Effectiveness of disposable dressing glove compared with normal dressings and bandages
研究概览
简要总结
Epidermolysis Bullosa (EB) is a group of genetic conditions causing extensive, painful skin blisters and wounds. Four main types of EB are recognised, which all affect the hands but those patients usually requiring hand therapy interventions have Recessive Dystrophic EB (RDEB).
The proof of concept study is part of the GLOVE (Generation and evaLuation Of hand therapy deVices for Epidermolysis bullosa) project. The project aims (i) to develop two hand therapy devices; a disposable dressing glove and splint glove to manage blisters, wounds and contractures that occur on the hands of people with RDEB (ii) to design and implement the Hand Therapy Online (HTO) electronic patient record system and (iii) to determine the cost effectiveness of the devices and the HTO system.
The proof of concept study focuses on testing the clinical performance and cost effectiveness of the dressing glove when compared with conventional dressings.
Recruited GLOVE participants will be invited to participate in the 14 week study, conducted using a quasi-experimental, n-of-1 research design. Patients who have not participated in GLOVE will also be invited to join. Participants will be asked to follow their usual dressing regime for six weeks. At week 7, they will be given several pairs of dressing gloves to replace their usual dressings, or starting to wear the glove if they avoid dressings normally and familiarise themselves. If participants usually wear their gloves to maintain their web spaces, they will wear these on top of the dressing glove to help assess compatibility.
Participants will provide feedback twice a week from week 7 on the dressing glove by answering 12 questions (TELER indicators) validated in the Pilot study (REC no: 16/LO/1046) using the HTO system. Data from the HTO system will be used by the Health Economist to determine the dressing glove and HTO's cost effectiveness.
详细描述
Principal research question/objective How effective is the disposable dressing glove when compared with the normal dressings and bandages used by the participants with RDEB based on 12 validated patient outcomes indicators that measure observations of hand function, device use, symptoms, and problems and limitations?
Secondary research questions Is the disposable dressing glove compatible with the SkinniesTM Web Spacer glove or any other make of glove used by the participants with RDEB to maintain their web spaces? Would you like to continue wearing the dressing glove? Is there anything else you(the participants) would like to tell us about the dressing glove?
Study design and methodology Study Design The proof of concept study of the dressing glove will be conducted using a quasi-experimental, n-of-1 research design drawn from the Medical Research Council Guidance for the design of complex interventions (MRC 2008). The reason for using this research design is due to a small sample of a small population of people with Recessive Dystrophic Epidermolysis Bullosa (RDEB). In addition, hand deformities amongst people with RDEB vary from one individual to another. Treatment and care also involve more than one intervention administered concurrently, for example wounds dressings, web-spacer gloves and splints. The researchers need to study the performance of these devices individually and together in terms of their effectiveness in delaying disease progression deformities.
The n-of-1 study design will enable investigation of the dressing glove performance against pre-determined performance criteria (12 patient recorded outcome measures on the HTO system) at the individual and group level with each participant acting as their own control.
Sample Size The sample for the GLOVE project is 14 participants. To date, seven adults and six children from pre-school age to school age have been recruited to the project from the project's two NHS sites, Guy's and St Thomas' (GSTT) NHS Foundation Trust and Great Ormond Street Hospital (GOSH) NHS Foundation Trust respectively. All the GLOVE participants will be invited to participate in the proof of concept study, subject to meeting the inclusion criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (over the age of seventeen) with RDEB who use or have used dressings and bandages on their hands.
- •Parents/carers of adults over the age of 17 with RDEB who use or have used dressings and bandages on their hands.
- •Parents/carers of babies, children and young people (up to the age of 17) with RDEB who use or have used dressings and bandages on their hands.
- •Babies, children and young people (age 1-17 years) with RDEB who use or have used dressings and bandages on their hands.
- •Able to communicate in English, verbally and in writing
- •Able to make an informed decision to participate and to give written consent
- •Not participating in concurrent clinical studies
排除标准
- •Babies aged less than 1 year old
- •Not able to communicate in English, verbally and in writing
- •Not able to make an informed decision to participate and to give written consent
- •Participating in concurrent clinical studies
结局指标
主要结局
Effectiveness of disposable dressing glove compared with normal dressings and bandages
时间窗: 14 weeks
Dressing glove performance against pre-determined performance criteria (12 patient recorded outcome measures on the HTO system) at the individual and group level with each participant acting as their own control.
次要结局
- Compatibility with the SkinniesTM Web Spacer glove(14 weeks)