Pilot study of the hand therapy online data collection system
Research type
Research Study
Full title
Generation and Evaluation of Hand Therapy Devices for Epidermolysis Bullosa (GLOVE project): pilot study of the hand therapy online data collection system
IRAS ID
200685
Contact name
Patricia Grocott
Contact email
Sponsor organisation
Research Management & Innovation Directorate, King's College London.
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
Pilot study of the Hand Therapy online data collection system
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).
This pilot study is part of the GLOVE (Generation and evaLuation Of hand therapy deVices for Epidermolysis bullosa) project. The GLOVE project aims to: (i) to develop two novel hand therapy devices to manage blisters, wounds and contractures that occur on the hands of people with RDEB (ii) to design and implement an integrated Hand Therapy-online (HTO) clinical assessment tool and (iii) determine the cost effectiveness of the novel devices and clinical assessment tool. A co-design methodology is being adopted whereby the research team work in collaboration with adults, carers and parents of children with RDEB, hand therapy clinicians and experts in wound care technologies.
The HTO system includes twelve patient recorded outcome indicators developed from qualitative interviews with patients and carers and consultations with clinicians. The pilot study objectives are:
1. To ask patients and carers to self report scores on each indicator via the HTO system over 6 weeks
2. To determine whether the indicators effectively measure observations of hand function, symptoms and clinically meaningful changes;
3. Collect pilot cost data on time taken and amount of material used to change dressings on the hands;
4. To use the indicator and cost data to assess how best to measure cost effectiveness;
5. To test the overall acceptability of patients and carers self reporting scores and cost data onto the HTO systemOnce this pilot study is complete we will use the approved HTO system to test the performance of the new hand therapy devices and measure how cost effective they are compared to current treatment.
REC name
London - South East Research Ethics Committee
REC reference
16/LO/1046
Date of REC Opinion
2 Jun 2016
REC opinion
Favourable Opinion