PREVENT-IAD Version 1
Research type
Research Study
Full title
PREVENTion and Treatment of Incontinence Associated Dermatitis (IAD) through optimising care (PREVENT-IAD): a feasibility cluster randomised controlled trial of the IAD Manual to prevent and treat IAD in participants with incontinence
IRAS ID
296167
Contact name
Susan Woodward
Contact email
Sponsor organisation
King's College London
ISRCTN Number
ISRCTN70866724
Clinicaltrials.gov Identifier
NIHR128865,
Duration of Study in the UK
0 years, 2 months, 28 days
Research summary
Incontinence-associated dermatitis (IAD) is caused by repeated contact with urine &/or faeces. Fourteen million UK adults have urinary incontinence and 6.5 million have bowel problems. IAD may be present in up to 51% of people with incontinence living at home and 30% living in care homes. Using preventative measures including skin care regimes, could halve the occurrence of IAD, however there are no specific guidelines for IAD management.
This NIHR funded PREVENT-IAD research project is taking a two-phased approach to complete the co-design of clinical guidance supported by an e-learning training programme for the prevention and treatment IAD. Phase 3 will follow to test this IAD care package in a 6-months feasibility two-arm cluster Randomised Controlled Trial (RCT).
The feasibility study will comprise of three parts:
(i) Recruit 4 care homes (2 in London and 2 in Wessex) and 1 home care agency in each location; 3 study sites to be randomised to use the IAD care package or 3 sites to no intervention/usual care for IAD. Recruited participants will include 48 adults with incontinence (with or without IAD) per study site. IAD data, recruitment and withdrawal rates will be collected from all participants at the start of RCT and then at 3 and 6 months.
(ii) Conduct follow-up interviews with 8-10 residents/community dwelling adults and/or a family member per IAD study site for views of care provided from the IAD care package. Hold focus groups/interviews with 8-10 recruited health professionals from each of the IAD care package study sites.
(iii) Observation of 50 skin care procedures at study sites which delivered the IAD care package to assess care staff's adherence to its use.
The feasibility data will be used to refine a future 4-year cluster RCT to test the clinical and cost-effectiveness of the IAD care package.
REC name
London - Queen Square Research Ethics Committee
REC reference
23/LO/0363
Date of REC Opinion
7 Jul 2023
REC opinion
Further Information Favourable Opinion