Condition category
Skin and Connective Tissue Diseases
Date applied
27/02/2020
Date assigned
28/02/2020
Last edited
02/03/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

http://www.kcl.ac.uk

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

Publication citations

Additional files

Editorial Notes

02/03/2020: Internal review. 28/02/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR) HTA.