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.
- primary care
- world wide web technology
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Contributors MSa and KST conceived the study idea and initial study design in collaboration with IM, LY, PLi, HCW, JRC, MJR, SaL, BS, GG, TS, SiL, AR, AA and HK, with later input from JN, JH, SW, MSt, KG, KS and TB. Specific advice was given by BS and TB on trial design and medical statistics; IM, LY, KG, KS, PLe and LH on the process evaluation; and TS on the health economic evaluation. All the authors contributed to the drafting of the study protocol, led by IM, and approved the final manuscript.
Funding This study presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research programme (grant ref No RP-PG-0216-20007). Eczema Care Online (ECO) interventions were developed using LifeGuide software, which was partly funded by the NIHR Southampton Biomedical Research Centre (BRC). SiL was supported by a Wellcome senior research fellowship in clinical science (205039/Z/16/Z). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting or dissemination plans of this research. Refer to the Methods section for further details.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
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