The Eczema Care Online (ECO) trial RCT protocol: how clinical and cost-effective are two online interventions to support eczema self-care?
Eczema is a common skin condition characterised by itchy skin and dryness. Eczema can lead to sleep loss and poor quality of life. A common cause of poor control of eczema is the underuse of effective treatments. Reasons for underuse include: concerns about safety of treatments, time consuming treatments, and insufficient or conflicting advice about how to use treatments.
We have developed two online interventions to support self-care for people with eczema; one for young people aged 13-25 years and one for parents and carers of children aged 0-12 years. The interventions support self-management of eczema using interactive features and tailored content delivered in a series of modules. The interventions have been developed following evidence- (e.g. systematic reviews), theory- (e.g. behavioural analysis, logic model) and person-based (using iterative qualitative methods) approaches. Designed using open-source software tools, these online interventions can be accessed from mobile devices and computers. The trial websites also offer participants the opportunity to complete consent, baseline and all follow-up questionnaires online over a 52-week period.DesignThis study comprises two randomised controlled trials to assess the effectiveness of:1. the ECO intervention in young people with eczema aged 13-25 years 2. the ECO intervention in parents and carers of children with eczema aged 0-12 years Both trials will include an internal pilot phase and nested health economic and process evaluation studies.Participants400 participants will be recruited into the trial from GP surgeries across three sites; Southampton, Nottingham and Bristol. Recruitment will run until end of June 2021.Participants will be invited to participate if they:• are a young person aged 13-25 years or a parent/carer of a child aged 0-12 years• have a recorded diagnosis of eczema in their GP records and have obtained a prescription for this in the past 12 monthsPotential participants with a POEM score less than 5 will be excluded as having very mild or quiescent eczema.Intervention and comparatorParticipants will be randomised to one of two groups:1. Intervention: Usual care plus immediate access to the online intervention 2. Control: Usual care (with access to the online intervention after 52 weeks of follow-up)The primary outcome for both trials will be eczema severity over 24 weeks measured by 4-weekly Patient-Oriented Eczema Measure (POEM) which measures frequency of symptoms.Secondary outcomes include: Quality of Life, long-term eczema control, itch intensity measure, enablement, service use and medication use.
If these interventions prove to be effective, health professionals would be encouraged to recommend their use as part of standard care.
Improved self-care has the potential to benefit patients and carers through improved control of eczema and to the NHS through leading to more appropriate eczema care.