Plain English Summary
Background and study aims
Incontinence-associated dermatitis (IAD) is skin damage caused by repeated contact with urine, faeces or both. It causes pain, discomfort, infections and pressure sores. 14 million UK people have urinary incontinence and 6.5 million have bowel problems, but the number with IAD in the UK has not been reliably established. It may affect as many as 51% of people with incontinence living at home and up to 30% in nursing and residential care. Prevention and treatment involve skin cleansing & use of products to protect the skin, alongside continence promotion & correct use of incontinence pads, but there are no specific guidelines for IAD management. Many people provide this care (e.g. family carers, unregistered care workers, nurses). The risk of developing IAD could be halved using preventative measures. Researchers want to create genuine changes in the way IAD is prevented and treated and will do this by developing and testing a manual (book), that will include a lay version, with training materials.
They want to find out if the PREVENT-IAD manual, and a related training package, can be successfully used to guide the prevention & treatment of IAD in care homes & people’s own homes.
Public & patient involvement was key from the start and the researchers worked with patient groups (Bladder Health UK), people with IAD and their carers to develop their plans so that any changes in care will be of real benefit to patients, carers and health professionals.
Who can participate?
1. People who have an experience of urinary and/or faecal incontinence with or without incontinence-associated dermatitis either living in their own homes or in a residential or nursing care home.
2. Health professionals working with people with urinary and/or faecal incontinence in care homes and home care agencies in the sites where the study will take place
3. Informal carers and family members or patient representatives of people with urinary and/or faecal incontinence at the study sites.
What does the study involve?
Four large care homes & two home care agencies will be recruited to test the feasibility of the trial designed in phase 2 (link to the ISRCTN record of phase 1 and 2). The recruited centres will be randomized to one of two groups:
1. Provide training in using the manual to their staff and use the manual to provide care for 6 months. The investigators will assess whether the manual is used as planned by observing its use in practice.
2. Continue to provide usual care for 6 months
In all participating centres, 48 individual patient participants will be recruited per centre and records will be kept of how many stay in the study. At baseline, 3 and 6 months clinical patient participants will be assessed through clinical tools and questionnaires to measure the presence or severity of IAD.
Additionally, of the 48 participants recruited in each centre, a sub-set of 8-10 residents and/or their family members will join 8-10 care home staff who will be recruited to attend qualitative interviews to discuss their experience of being in the study, how the manual worked in practice and what helped or was a barrier to them using the manual.
What are the possible benefits and risks of participating?
There may be a small risk of becoming a little distressed when participants think about the way that bladder and bowel or skin problems affect them. It is unlikely that participants will receive any direct benefit from taking part in this study, but they may value the opportunity to be involved in research which has the potential to improve care for others
Where is the study run from?
King's College London (UK) and University of Southampton (UK)
When is the study starting and how long is it expected to run for?
December 2018 to February 2022
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Sue Woodward
sue.woodward@kcl.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Dr Sue Woodward
ORCID ID
http://orcid.org/0000-0001-5390-7253
Contact details
King's College London
57 Waterloo Road
London
SE1 8WA
United Kingdom
+44 (0)2078483469
sue.woodward@kcl.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
NIHR128865
Study information
Scientific title
PREVENTion and treatment of Incontinence-Associated Dermatitis (IAD) through optimizing care using the IAD Manual (PREVENT-IAD), part 3
Acronym
PREVENT-IAD
Study hypothesis
Is it feasible to implement a manualized package of care for the prevention and treatment of IAD that can be delivered by a range of NHS and other relevant caregivers?
Ethics approval
Not provided at time of registration
Study design
Interventional cluster-randomized feasibility study
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Incontinence-associated dermatitis
Intervention
The IAD Manual, developed during parts 1 and 2 of the study www.isrctn.com/ISRCTN26169429) will be implemented following the training of care staff and compared with usual care in care homes and home care agencies in a feasibility cluster randomized controlled trial.
In phase 3, four large care homes & two home care agencies will be recruited to test the feasibility of the trial designed in phase 2. The recruited centres will be randomized using stratified computer randomisation by the trial statistician to one of two groups:
1. Provide training in using the manual to their staff and use the manual to provide care for 6 months. The investigators will assess whether the manual is used as planned by observing its use in practice
2. Continue to provide usual care for 6 months
In all participating centres, 48 individual patient participants will be recruited per centre and records will be kept of how many stay in the study. At baseline, 3 and 6 months clinical patient participants will be assessed through clinical tools and questionnaires to measure the presence or severity of IAD.
Additionally, of the 48 participants recruited in each centre, a sub-set of 8-10 residents and/or their family members will join 8-10 care home staff who will be recruited to attend qualitative interviews to discuss their experience of being in the study, how the manual worked in practice and what helped or was a barrier to them using the manual.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Incontinence-Associated Dermatitis presence and severity measured and recorded according to the core outcome set for IAD (erythema, maceration, erosion, pain and satisfaction) using Ghent Global Incontinence-Associated Dermatitis Categorisation Tool (GLOBIAD), Incontinence-Associated Dermatitis Intervention Tool (IADIT), Wong-Baker Faces Scale and Self-Assessment of Psoriasis Symptoms (SAPS) at baseline, 3 and 6 months
Secondary outcome measures
1. Recruitment rates/attrition will be assessed through investigator notes at 6 months
2. Intervention fidelity will be assessed through non-participant observation at 3 and 6 months
3. Acceptability of intervention will be assessed through qualitative interviews of care home staff, patients and carers at 6 months
Overall trial start date
09/12/2018
Overall trial end date
28/02/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Urinary and/or faecal incontinence with or without IAD receiving care at home from a home care agency or within a care home providing nursing and/or residential care
2. Capacity to give valid informed consent or declaration by personal or nominated consultee where resident’s capacity to give informed consent is lacking as defined under the Mental Capacity Act 2005
3. Relative of an adult with incontinence receiving care at home or as a care home resident
4. Care staff providing incontinence care employed by a care home or home care agency involved in the study
Participant type
Mixed
Age group
Mixed
Gender
Both
Target number of participants
6 clusters recruiting 48 individual resident participants per site and a sub-set of 8-10 residents/family members and 8-10 care home staff for qualitative interviews. Total target recruitment - 288
Participant exclusion criteria
1. Residents who are continent of both urine and feces
2. Personnel not involved in direct continence care such as work experience, volunteer and short-term agency staff
Recruitment start date
01/03/2021
Recruitment end date
31/08/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
57 Waterloo Road
London
SE1 8WA
United Kingdom
Sponsor information
Organisation
King's College London
Sponsor details
Strand
London
WC2R 2LS
United Kingdom
+44 (0)207 8485454
reza.razavi@kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Publication of the trial protocol and a paper detailing the findings of this feasibility RCT in a high-impact peer-reviewed journal and on the HTA website.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
31/03/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list