Evidence map›Paper›PMID 41299651›Full record

ArticlePilot and feasibility studies2025

PREVENTion and treatment of Incontinence-Associated Dermatitis (IAD) through optimising care: development and feasibility cluster randomised trial of the IAD-Manual (PREVENT-IAD).

Sue Woodward, Tanya Graham, Nicholas Beckley-Hoelscher, Dimitri Beeckman, Christopher Chatterton, Mandy Fader, Joanne M Fitzpatrick, Ruth Harris, Jan Kottner, Christine Norton and 2 more

Abstract read
In one paragraph

Article in Pilot and feasibility studies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Sue WoodwardFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, 57 Waterloo Road, London, SE1 8WA, UK. sue.woodward@kcl.ac.uk.ORCID http://orcid.org/0000-0001-5390-7253
Tanya GrahamFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, 57 Waterloo Road, London, SE1 8WA, UK.
Nicholas Beckley-HoelscherDept Biostatistics & Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, De Crespigny Park, London, UK.
Dimitri BeeckmanDepartment of Public Health and Primary Care, University Centre for Nursing and Midwifery, Campus UZGent, Entrance 42, Floor 5, C. Heymanslaan 10, Ghent, 9000, Belgium.
Christopher ChattertonPatient representative, London, UK.
Mandy FaderSchool of Health Sciences, University of Southampton, Southampton, SO17 1BJ, UK.
Joanne M FitzpatrickFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, 57 Waterloo Road, London, SE1 8WA, UK.
Ruth HarrisFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, 57 Waterloo Road, London, SE1 8WA, UK.
Jan KottnerCharité-Universitätsmedizin Berlin, Berlin, Germany.
Christine NortonFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, 57 Waterloo Road, London, SE1 8WA, UK.
Sangeeta SooriahFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, 57 Waterloo Road, London, SE1 8WA, UK.
Peter R WorsleySchool of Health Sciences, University of Southampton, Southampton, SO17 1BJ, UK.

Funding

Health Technology Assessment Programme NIHR128865
6 · The paper itself

Abstract

backgroundIncontinence-associated dermatitis (IAD) is prevalent in long-term care (LTC) facilities and homecare settings amongst adults who are incontinent of urine and/or faeces. Strategies to protect skin integrity are needed. This study aimed to co-design and test the feasibility of a training manual and care guidance (IAD-Manual) to prevent and treat IAD in LTC facilities and homecare settings.

methodsThis was a three-phase study: (1) developing the intervention, (2) designing the empirical study (a cluster RCT with an embedded process evaluation) to assess its effectiveness (not reported here) and (3) a 3-month feasibility study. The feasibility study recruited three LTC facilities and two homecare providers, randomising them (each as a cluster) to intervention or control. Process evaluation interviews with two care recipients, 11 family carers and 13 care staff implementing the IAD-Manual and their managers were conducted. Observations of 22 episodes of care assessed fidelity to the intervention. Qualitative data were analysed using thematic analysis. Summary feasibility outcome measures using means or proportions together with 95% confidence intervals were reported.

resultsFive sites were recruited from 49 approached. All randomised sites were retained. Seventy-six (16% [95% CI: 13-20%]) of the 477 participants approached were randomised, of which 58 (76% [95% CI: 65-85%]) completed the study. Candidate IAD outcomes had complete or almost-complete 3-month outcome data in those participants remaining, whereas other outcome measures had contrastingly poor data completeness largely due to participant cognitive impairment. Process evaluation showed few potential participants had the capacity to consent, and gaining consultee approval was challenging. Care staff at study sites liked the IAD-Manual, describing it as 'helpful'. Twenty-eight people accessed the IAD-Manual online, and 15 care staff downloaded a certificate of completion of training. Intervention fidelity was not always observed.

conclusionsIt was feasible to develop the IAD-Manual. The RCT as designed was not feasible in its original form, with specific challenges regarding site and participant recruitment, governance and intervention fidelity.

trial registrationThis trial was prospectively registered on 07/02/2020 (intervention development) ISRCTN26169429 and 28/02/2024 (feasibility study) ISRCTN70866724.

Indexed as

Co-designFeasibility cluster RCTIncontinence-associated dermatitisIntervention developmentLong-term care (LTC)PreventionSocial careTraining manualTreatment

Identifiers

PMID41299651
PMCPMC12659393

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.