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, Beth Stuart, Tracey Sach, Julie Hooper, Sylvia Wilczynska, Mary Steele, Kate Greenwell, Katy Sivyer, Lucy Yardley, Hywel C. Williams, Joanne Rachel Chalmers, Paul Leighton, Laura Howells, Matthew J. Ridd, Sandra Lawton, Gareth Griffiths, Jacqui Nuttall, Sinéad M. Langan, Amanda Roberts, Amina AhmedHayden Kirk, Taeko Becque, Paul Little, Kim S. Thomas, Miriam Santer

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Abstract

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 aimed to evaluate clinical and cost effectiveness of the two interventions.
Methods and analysis
Design: Two independent, pragmatic, unmasked, parallel group randomised controlled trials with internal pilots and nested health economic and process evaluation studies. Setting: Participants will be recruited from GP practices in England. Participants: young people aged 13-25 years with eczema and parents / carers of children aged 0-12 years with eczema, excluding inactive or very mild eczema (5 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 an NHS and personal social service perspective. Qualitative and quantitative process evaluation will help understand 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 policymakers.
Original languageEnglish
Article numbere045583
Number of pages8
JournalBMJ Open
Volume11
Issue number2
DOIs
Publication statusPublished - 5 Feb 2021

Keywords

  • eczema
  • primary care
  • world wide web technology

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