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We are seeking an independent statistician to join our Study Steering Committee for a six site feasibility cluster RCT.
Trial Details
Title: PREVENTion and Treatment of Incontinence Associated Dermatitis (IAD) through optimising care: development of the IAD Manual (PREVENT-IAD)
Chief Investigator: Dr Sue Woodward
Funder: NIHR - HTA
Sponsor: King’s College London
Supported by King’s Clinical Trials unit
The study will run over 24 months. Meetings may be held remotely via teleconference or in person depending on your availability.  We anticipate 3 meetings over the 2 year period (one in year one and two in year two). Travel expenses will be reimbursed.
The overarching research aim is to assess the feasibility of developing and testing the feasibility of a manualised package of care to prevent and treat incontinence associated dermatitis in community settings. The study will take place over three phases:

  1.  Develop & manualise an optimal care package for the prevention & treatment of IAD (IAD Manual) within care homes & by care agencies, including a training, implementation & dissemination plan. (Year 1)
  2.  Design a future trial of the clinical & cost-effectiveness of the IAD Manual (Year 1)
  3.  Conduct a feasibility cluster randomised controlled trial (RCT) of the IAD Manual (Year 2).
See study synopsis below.
We are looking for involvement in the oversight committee to start from 1st March 2020.  Please send queries, expressions of interest with CV to [log in to unmask]<mailto:[log in to unmask]> before 16th February 2020.
Study Synopsis:
Study Title
PREVENTion and treatment of Incontinence-Associated Dermatitis (IAD) through optimising care: development and feasibility of the IAD Manual (PREVENT-IAD)
NIHR Study No.
HTA NIHR128865
Type of study
Cluster randomised intervention feasibility study
Trial Design
Intervention co-design followed by 6 site feasibility cluster RCT
Trial Participants
Planned Sample Size
288 participants, 144 in each arm
Follow-up duration
6 months from implementation of the IAD Manual in care homes/home care agencies
Planned Trial Period
24 months in total, 0-12 months intervention development and 12-24 months intervention feasibility testing
Research Aim
to develop and assess the feasibility of a manualised package of care to prevent/treat IAD in community settings
The overarching research aim is to assess the feasibility of developing and testing the feasibility of a manualised package of care to prevent and treat incontinence associated dermatitis in community settings. The study will take place over three phases:

  1.  Develop & manualise an optimal care package for the prevention & treatment of IAD (IAD Manual) within care homes & by care agencies, including a training, implementation & dissemination plan. (Year 1)
  2.  Design a future trial of the clinical & cost-effectiveness of the IAD Manual (Year 1)
  3.  Conduct a feasibility cluster randomised controlled trial (RCT) of the IAD Manual (Year 2).
Primary Objectives
To develop and assess the feasibility of the IAD Manual
Primary outcome
Change in core outcome set for IAD (IAD severity, IAD pain, resident satisfaction) compared to those receiving standard care over the same period.
Secondary Objectives

To assess feasibility outcomes:

  1.  Recruitment rates (cluster and individual)
  2.  Acceptability of intervention and study design for patients/residents/family members and staff (qualitative)
  3.  Attrition - attrition is a common issue affecting studies in care homes due to study withdrawal, high mortality, comorbidity, hospitalisation and transfers to another facility
  4.  Intervention fidelity (assessed through observation and review of documentation)

To assess the experience of the implementation of the IAD Manual for residents and staff through qualitative interviews.
Interventions
Standard care:  Standard care and standard treatment to prevent/treat IAD
Intervention arm: 6 months care guided by IAD Manual


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