Dermatitis and eczema Skin and Connective Tissue Diseases Dermatitis and eczema
Conditions
Interventions
Two trials (trial-YP and trial-PC) of two online behavioural interventions will be carried out. Intervention-YP is for young people aged 13-25 with eczema and intervention-PC is for parents/carers of
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Trial-YP: 1. Young person aged 13-25 years with eczema 2. Identified from GP records as having eczema and have obtained a prescription for eczema treatment in the past 12 months 3. POEM score greater than 5 to include mild to severe eczema, but exclude those with very mild eczema to avoid floor effects 4. Internet access Trial-PC: 1. Parent / carer of a child aged 0-12 years with eczema 2. Child was identified from GP records as having eczema and has obtained a relevant prescription in the past 12 months 3. Child has a POEM score greater than 5 to include mild to severe eczema, but exclude those with very mild eczema 4. Have internet access Only 1 person per household will be able to take part in each trial. If a parent / carer in trial-PC has more than one child who meets the inclusion criteria they will be asked to specify one child to participate in the trial.
Exclusion criteria
Exclusion criteria: 1. Unable to give informed consent 2. Unable to read and write English as the intervention content and outcome measures are in English 3. Taken part in another eczema intervention in the past 3 months. 4. Took part in think-aloud interviews as part of ECO intervention development. (Qualitative interviewees who did not view intervention materials will NOT be excluded)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures for both trials will be eczema severity over 24 weeks measured by 4-weekly POEM (Patient-Oriented Eczema Measure) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Eczema severity will be measured using the POEM (Patient-Oriented Eczema Measure) 4-weekly from week 0 to 52-week follow-up (corrected/moved from the primary outcome measures 23/09/2020) 2. Quality of Life will be measured in both trials: 2.1. In trial-YP, Quality of Life will be measured using the EQ-5D-5L self-completed by the young person, at baseline, 24-week and 52-week follow-up 2.2. In trial-PC, Quality of Life will be measured by proxy using the Child Health Utility - Nine Dimensions (CHU-9D) for those children aged 2 to 12 years, at baseline, 24-week and 52-week follow-up 3. Long-term control will be measured by RECAP (Recap for atopic eczema patients), at baseline, 24-week and 52-week follow-up 4. Itch intensity measure (worst itch in last 24 hours) measured using Itch intensity single item (only validated for adults). In Trial-YP but not for Trial-PC., at baseline, 24-week and 52-week follow-up 5. Enablement, the self-perceived ability to understand and cope with health issues, will be measured using the Patient Enablement Instrument (PEI), at baseline, 24-week and 52-week follow-up 6. Health service use and medication use will be measured by medical notes review, during the 3 month period prior to baseline and the whole 52 week trial period 7. Cost-effectiveness combining quality of life and health service use and medication use, during the 3 month period prior to baseline and the whole 52 week trial period 8. Prior belief about the effectiveness of the intervention measured using self-report at baseline 9. Online resource use (websites or apps) for eczema measured using self-report at baseline 10. Self-reported barriers to adherence will be measured using the Problematic Experiences of Therapy Scale (PETS), at baseline, 24-week and 52-week follow-up 11. Frequency of treatment use (emollients, topical steroids, and topical calcineurin inhibitors) over the past week will be measured by self-report, at baseline, 24-week and 52-week follow-up 12. Interve | — |
Countries
England, United Kingdom
Contacts
Public ContactJulie Hooper
Outcome results
None listed