Supporting self-care for eczema: protocol for two randomised controlled trials of ECO (Eczema Care Online) interventions for young people and parents/carers
Ingrid Muller,
Miriam Santer,
Taeko Becque,
Beth Stuart,
Paul Little,
Matthew J Ridd,
Joanne R Chalmers,
Lucy Yardley,
Paul Leighton,
Amanda Roberts,
Hywel C Williams,
Julie Hooper,
Kate Greenwell,
Sinéad M Langan,
Kim S Thomas,
Gareth Griffiths,
Sandra Lawton,
Jacqui Nuttall,
Tracey Sach,
Sylvia Wilczynska,
Mary Steele,
Katy Sivyer,
Laura M Howells,
Amina Ahmed,
Hayden Kirk
Affiliations
Ingrid Muller
2 Primary Care Research Centre, School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK
Miriam Santer
Primary Care Research Centre, University of Southampton, Southampton, UK
Taeko Becque
2 Primary Care Research Centre, School of Primary Care, Population Science, and Medical Education, University of Southampton, Southampton, UK
Beth Stuart
2 Queen Mary University of London, London, UK
Paul Little
Primary Care Research Centre, University of Southampton Faculty of Medicine, Southampton, UK
Matthew J Ridd
Population Health Sciences, University of Bristol, Bristol, UK
Joanne R Chalmers
Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK
Lucy Yardley
Bristol Medical School, University of Bristol, Bristol, UK
Paul Leighton
2 School of Medicine, University of Nottingham, Nottingham, UK
Amanda Roberts
School of Psychology, University of Lincoln, Lincoln, UK
Hywel C Williams
Lifespan and Population Health, University of Nottingham, Nottingham, UK
Julie Hooper
trial manager
Kate Greenwell
University Of Southampton, Southampton, UK
Sinéad M Langan
1 London School of Hygiene & Tropical Medicine, London, UK
Kim S Thomas
5 Centre for Evidence Based Dermatology, University of Nottingham, Nottingham, UK
Gareth Griffiths
3 Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK
Sandra Lawton
nurse consultant dermatology
Jacqui Nuttall
11 Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK
Introduction Eczema care requires management of triggers and various treatments. We developed two online behavioural interventions to support eczema care called ECO (Eczema Care Online) for young people and ECO for families. This protocol describes two randomised controlled trials (RCTs) aimed to evaluate clinical and cost-effectiveness of the two interventions.Methods and analysis Design: Two independent, pragmatic, unmasked, parallel group RCTs with internal pilots and nested health economic and process evaluation studies. Setting: Participants will be recruited from general practitioner practices in England. Participants: Young people aged 13–25 years with eczema and parents and carers of children aged 0–12 years with eczema, excluding inactive or very mild eczema (five or less on Patient-Oriented Eczema Measure (POEM)). Interventions: Participants will be randomised to online intervention plus usual care or to usual eczema care alone. Outcome measures: Primary outcome is eczema severity over 24 weeks measured by POEM. Secondary outcomes include POEM 4-weekly for 52 weeks, quality of life, eczema control, itch intensity (young people only), patient enablement, health service and treatment use. Process measures include treatment adherence, barriers to adherence and intervention usage. Our sample sizes of 303 participants per trial are powered to detect a group difference of 2.5 (SD 6.5) in monthly POEM scores over 24 weeks (significance 0.05, power 0.9), allowing for 20% loss to follow-up. Cost-effectiveness analysis will be from a National Health Service and personal social service perspective. Qualitative and quantitative process evaluation will help understand the mechanisms of action and participant experiences and inform implementation.Ethics and dissemination The study has been approved by South Central Oxford A Research Ethics Committee (19/SC/0351). Recruitment is ongoing, and follow-up will be completed by mid-2022. Findings will be disseminated to participants, the public, dermatology and primary care journals, and policy makers.Trial registration number ISRCTN79282252.
