Tools
Tools
Muller, Ingrid, Stuart, Beth, Sach, Tracey 
ORCID: https://orcid.org/0000-0002-8098-9220, Hooper, Julie, Wilczynska, Sylvia, Steele, Mary, Greenwell, Kate, Sivyer, Katy, Yardley, Lucy, Williams, Hywel C., Chalmers, Joanne Rachel, Leighton, Paul, Howells, Laura, Ridd, Matthew J., Lawton, Sandra, Griffiths, Gareth, Nuttall, Jacqui, Langan, Sinéad M., Roberts, Amanda, Ahmed, Amina, Kirk, Hayden, Becque, Taeko, Little, Paul, Thomas, Kim S. and Santer, Miriam
(2021)
Supporting self-care for eczema: protocol for two randomised controlled trials of ECO (Eczema Care Online) interventions for young people and parents/carers.
BMJ Open, 11 (2).
ISSN 2044-6055
Preview |
PDF (Published_Version)
- Accepted Version
Available under License Creative Commons Attribution. Download (725kB) | Preview |
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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | eczema,primary care,world wide web technology,medicine(all) ,/dk/atira/pure/subjectarea/asjc/2700 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Groups > Health Economics Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit Faculty of Medicine and Health Sciences > Research Groups > Public Health and Health Services Research (former - to 2023) |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 11 Feb 2021 01:05 |
| Last Modified: | 23 Oct 2022 02:12 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/79219 |
| DOI: | 10.1136/bmjopen-2020-045583 |
Downloads
Downloads per month over past year
Actions (login required)
 |
View Item |