RT Journal Article
SR Electronic
T1 Supporting self-care for eczema: protocol for two randomised controlled trials of ECO (Eczema Care Online) interventions for young people and parents/carers
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e045583
DO 10.1136/bmjopen-2020-045583
VO 11
IS 2
A1 Ingrid Muller
A1 Beth Stuart
A1 Tracey Sach
A1 Julie Hooper
A1 Sylvia Wilczynska
A1 Mary Steele
A1 Kate Greenwell
A1 Katy Sivyer
A1 Lucy Yardley
A1 Hywel C Williams
A1 Joanne R Chalmers
A1 Paul Leighton
A1 Laura M Howells
A1 Matthew J Ridd
A1 Sandra Lawton
A1 Gareth Griffiths
A1 Jacqui Nuttall
A1 Sinead M Langan
A1 Amanda Roberts
A1 Amina Ahmed
A1 Hayden Kirk
A1 Taeko Becque
A1 Paul Little
A1 Kim S Thomas
A1 Miriam Santer
YR 2021
UL http://bmjopen.bmj.com/content/11/2/e045583.abstract
AB 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.