Development of a manual to guide care for people with incontinence to prevent or treat incontinence associated dermatitis (sore skin), part 3
| ISRCTN | ISRCTN70866724 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70866724 |
| IRAS number | 296167 |
| Secondary identifying numbers | NIHR128865 |
- Submission date
- 27/02/2020
- Registration date
- 28/02/2020
- Last edited
- 17/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
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 December 2024
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Sue Woodward
sue.woodward@kcl.ac.uk
Contact information
Public
King's College London
57 Waterloo Road
London
SE1 8WA
United Kingdom
 ORCID ID |
0000-0001-5390-7253 |
|---|---|
| Phone | +44 (0)2078483469 |
| sue.woodward@kcl.ac.uk |
Study information
| Study design | Interventional cluster-randomized feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | PREVENTion and treatment of Incontinence-Associated Dermatitis (IAD) through optimizing care using the IAD Manual (PREVENT-IAD), part 3 |
| Study acronym | PREVENT-IAD |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Current primary outcome measure as of 17/10/2024: 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), Minimum Data Set (MDS) for IAD, Wong-Baker Faces Scale, Self-Assessment of Psoriasis Symptoms (SAPS), and the Hospital Anxiety and Depression Scale (HADs) at baseline, 3 and 6 months. Care staff from all six study sites will also use the Minimum Data Set (MDS) for IAD to collect weekly data from the recruited adults living in care homes and their own homes. _____ Previous 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 study start date | 09/12/2018 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | 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 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2022 |
| Date of final enrolment | 30/11/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SE1 8WA
United Kingdom
Sponsor information
University/education
Strand
London
WC2R 2LS
England
United Kingdom
| Phone | +44 (0)207 8485454 |
|---|---|
| reza.razavi@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 23/12/2024 | 17/01/2025 | Yes | No |
Editorial Notes
17/01/2025:Publication reference added.
17/10/2024: The following changes were made to the trial record:
1. The IRAS number was added.
2. The primary outcome measure was changed.
3. The participant level data sharing statement was added.
23/02/2024: The following changes have been made:
1. The overall study end date was changed from 30/06/2023 to 31/12/2024.
2. The intention to publish date was changed from 30/06/2023 to 31/12/2024.
17/05/2022: The recruitment start date has been changed from 01/05/2022 to 01/07/2022.
23/02/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/11/2021 to 01/05/2022.
2. The recruitment end date was changed from 31/01/2022 to 30/11/2022.
3. The overall trial end date was changed from 28/02/2022 to 30/06/2023.
4. The intention to publish date was changed from 31/03/2022 to 30/06/2023.
16/03/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/03/2021 to 01/11/2021.
2. The recruitment end date was changed from 31/08/2021 to 31/01/2022.
02/03/2020: Internal review.
28/02/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR) HTA.
