Proof of Concept Study for a Dressing Glove

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Brief Title

Proof of Concept Study for a Dressing Glove

Official Title

Generation and Evaluation of Hand Therapy Devices for Epidermolysis Bullosa (GLOVE Project): Proof of Concept Study for a Dressing Glove

Brief Summary

      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.
    

Detailed Description

      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.

      Method of Recruitment The EB clinical team (GSTT; GOSH) will identify potential participants
      who meet the inclusion criteria for the study. The KCL research team will send a letter of
      invitation to these participants containing age appropriate information sheets, assent and
      consent forms (Letter of invitation V2 10 Jan 2017). The letter also has the contact details
      for the King's College Research team should the participants require further information.
      Participants will have a minimum of a week to decide if they would like to participate in the
      study. They will be invited to return the reply slip to the EB clinicians who will return
      them to the Chief Investigator. The EB clinicians will recruit and consent those participants
      who have not be involved in the GLOVE project to date. Those who have will be recruited and
      consented by the KCL research team. Adults (18 years and over) or their carers will be asked
      to provide written informed consent. Children (7-17 years) will also be asked to provide
      written informed consent. Their parents will also be asked to provide their written consent
      for their child to participate. Children aged 4-6 will be invited to provide written assent,
      once their parents have agreed to this. The parents will also provide their written consent,
      as will the parents of babies and toddlers. The consent and assent forms will be returned to
      the Chief Investigator at King's College London and kept in a locked cupboard, separated from
      the data in order to maintain data anonymity.

      Conduct of the Proof of Concept Study The study will take place over 14 weeks. 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 familiarise themselves with. At week 8,
      participants will replace their usual dressings and bandages with the dressing glove or start
      to wear the gloves if they avoid dressings normally. If participants usually wear their
      gloves to maintain their web spaces, they will continue to wear these on top of the dressing
      glove to help assess compatibility.

      Method of data collection Participants will provide feedback twice a week on the dressing
      glove by answering 12 questions (TELER indicators) using the Hand Therapy Online system
      (HTO), which is an electronic patient record system (HTO indicators V2 10 Jan 2017; Patient
      Guide V3). The indicators and the HTO were validated in the Pilot study (REC no: 16/LO/1046).

      There are three types of measurements 1) TELER indicators, (2) physical measurements (3)
      measures of cost. The TELER indicators are a tool to measure observations of hand function,
      device use, symptoms and problems/limitations. The indicators measure clinically meaningful
      changes comprising an improvement, deterioration or no change in hand function from one time
      point to another. Each indicator is on a scale of six clinical steps or 'codes'. Code 5 is
      best case scenario or the treatment goal and code 0 is worst case scenario (i.e. the problem
      to be avoided) with codes 4, 3, 2 and 1 being clinically meaningful steps towards or away
      from the treatment goal.

      GLOVE participants recruited to the study will be trained by the KCL researchers to use HTO
      system to provide feedback twice a week on the dressing glove by answering the TELER
      indicators for the dressing glove validated in the pilot study (REC no: 16/LO/1046).

      The data from the HTO system will inform the methodology for measuring the cost effectiveness
      of the dressing glove.

      Data analysis Numerical data analysis comprises automated calculation of patient specific
      index numbers within the digitised system (Deficit Index, Improvement Index, Maintenance
      Index, and Effectiveness Index) and two group indices (Health Status Index and Health Gain
      Index). An analysis of the costs of standard care versus the intervention will also be
      performed taking into account the use of products, time taken for wound care, and impact of
      wound care on daily living.

      Researcher bias will be minimised by their minimal direct contact with the data collection
      process. In addition no attempt has been made to design out any confounding variables,
      thereby replicating the situations in which patients are normally treated.

      Report writing and dissemination The Chief Investigator will take responsibility for writing
      the reports during the study and disseminating the findings, positive and negative, through
      publications and conference presentations.

      The findings from the study will enable generalisations to be made to the wider population of
      RDEB patients with similar disease progression hand deformities that require the constant use
      of wound dressing and web-spacer gloves (Research Protocol V2 10 Jan 2017.
    


Study Type

Observational


Primary Outcome

Effectiveness of disposable dressing glove compared with normal dressings and bandages

Secondary Outcome

 Compatibility with the SkinniesTM Web Spacer glove

Condition

Epidermolysis Bullosa Dystrophica

Intervention

Dressing Glove

Study Arms / Comparison Groups

 Dressing Glove
Description:  Fitting bespoke dressing gloves (viscose Class 1 medical device) and evaluating dressing glove performance in the management of blisters using patient recorded outcome measures. The aim is to obtain proof of concept data for the dressing glove as an acceptable alternative to patch work dressings held in place with bandages.
The study protocol recommends a daily change of the dressing glove but the patients also contribute their preference for frequency of dressing changes.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

14

Start Date

May 3, 2017

Completion Date

January 31, 2018

Primary Completion Date

January 31, 2018

Eligibility Criteria

        Inclusion Criteria:

          1. Adults (over the age of seventeen) with RDEB who use or have used dressings and
             bandages on their hands.

          2. Parents/carers of adults over the age of 17 with RDEB who use or have used dressings
             and bandages on their hands.

          3. 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.

          4. Babies, children and young people (age 1-17 years) with RDEB who use or have used
             dressings and bandages on their hands.

          5. Able to communicate in English, verbally and in writing

          6. Able to make an informed decision to participate and to give written consent

          7. Not participating in concurrent clinical studies

        Exclusion Criteria:

          1. Babies aged less than 1 year old

          2. Not able to communicate in English, verbally and in writing

          3. Not able to make an informed decision to participate and to give written consent

          4. Participating in concurrent clinical studies
      

Gender

All

Ages

1 Year - N/A

Accepts Healthy Volunteers

No

Contacts

Patricia Grocott, PhD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03241628

Organization ID

17/LO/0420


Responsible Party

Sponsor

Study Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

 King's College London

Study Sponsor

Patricia Grocott, PhD, Principal Investigator, NIHR i4i


Verification Date

February 2018