Condition category
Skin and Connective Tissue Diseases
Date applied
23/01/2020
Date assigned
07/02/2020
Last edited
07/02/2020
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 involves 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. We 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.

We want to find out if:
1. We can develop a manual with people with IAD, their carers & health professionals, with a
related training package, to guide the prevention & treatment of IAD in care homes & people’s own homes
2. We can work together to design a future research study to establish whether the manual works to prevent and treat IAD and could be tested on a larger group of people

Public & patient involvement was key from the start and we worked with patient groups (Bladder Health UK), people with IAD and their carers to develop our 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
2. Health professionals working with people with urinary and/or faecal incontinence in a care home, care agency, district nursing team, continence advisory service, tissue viability service, other community and primary care service (such as community pharmacist or GP) or as an NHS registered nurse working in secondary care
3. Informal carers, family members or patient representatives of people with urinary and/or faecal incontinence

What does the study involve?
In phase 1, 10-15 people with IAD and their carers and 10-15 health professionals will be recruited to attend 4 meetings to discuss how they deal with IAD and what they need to improve this care. In these meetings, there will also be discussions around the content of a manual to guide the prevention and treatment of IAD, what might help or stop people using the manual and the training and resources that would be needed so that a manual could be introduced into care homes and the community.

In phase 2 the same participants will attend a meeting to design a future study to test if the manual works and can be successfully introduced into a real-world setting.

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
London
SE1 8WA
United Kingdom
+44 07941932529
sue.woodward@kcl.ac.uk

Type

Scientific

Additional contact

Dr Sue Woodward

ORCID ID

http://orcid.org/0000-0001-5390-7253

Contact details

King's College London
57 Waterloo Road
London
London
SE1 8WA
United Kingdom
07941932529
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: development and feasibility of the IAD Manual (PREVENT-IAD), Part 1 and 2

Acronym

PREVENT-IAD

Study hypothesis

Is it feasible to develop and manualize a 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

Pending as of 24/01/2020, the King's College London Psychiatry, Nursing and Midwifery Research Ethics Subcommittee

Study design

Focus group-based observational qualitative study

Primary study design

Observational

Secondary study design

Qualitative study

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 (IAD)

Intervention

The study has 3 phases. The manualized package of care (IAD Manual) will be developed and designed during phase 1 and tested during phase 3.

In phase 1, 10-15 people with IAD and their carers and 10-15 health professionals will be recruited to attend 4 meetings to discuss how they deal with IAD and what they need to improve this care. In these meetings, there will also be discussions around the content of a manual to guide the prevention and treatment of IAD, what might help or stop people using the manual and the training and resources that would be needed so that a manual could be introduced into care homes and the community.

In phase 2 the same participants will attend a meeting to design a future study to test if the manual works and can be successfully introduced into a real-world setting.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Identification of the content of a manual to guide the prevention and treatment of IAD, what might help or stop people using the manual and the training and resources that would be needed so that a manual could be introduced into care homes and the community, through focus groups at baseline 3, 6, 9 and 12 months
2. Development of a feasibility study, designed to test the efficacy of the manual and training developed in phase 1 in the prevention and treatment of IAD, through focus groups at baseline 3, 6, 9 and 12 months

Secondary outcome measures

Recruitment rates/attrition will be assessed through investigator notes at 12 months

Overall trial start date

09/12/2018

Overall trial end date

28/02/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Experience of urinary and/or faecal incontinence with or without IAD
2. Health professional working in a care home, care agency, district nursing team, continence advisory service, tissue viability service, other community and primary care service (such as community pharmacist or GP) or as an NHS registered nurse working in secondary care with older people
3. Informal carer, family member or patient representative of those with experience of urinary and/or faecal incontinence with or without IAD

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

10-15 health professionals and 10-15 residents, informal carers and/or family members

Participant exclusion criteria

None

Recruitment start date

01/03/2020

Recruitment end date

31/08/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
King's College London 57 Waterloo Road London
London
SE1 8WA
United Kingdom

Trial participating centre

University of Southampton
University Road
Southampton
SO17 1BJ
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Strand
London
WC2R 2LS
United Kingdom
020-7848-5454
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

1. Updated Cochrane review at approximately 6 to 9 months
2. Submission of a paper detailing the interim findings from workshop one of phase 1 following presentation at a conference at approximately 9 to12 months
3. Registration on the International Standard Randomised Controlled Trial Number Register (ISRCTN) and submission of the trial protocol for the RCT developed in Phase 2

IPD sharing statement:
The datasets generated during and/or analyzed during the current study will be available upon request

Intention to publish date

31/03/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/01/2020: Trial’s existence confirmed by the National Institute of Health Research.