Eczema Care Online RCT
Research type
Research Study
Full title
Eczema Care Online (ECO): two randomised controlled trials of online interventions to support self care for eczema for young people with eczema and for parents of children with eczema
IRAS ID
261322
Contact name
Miriam Santer
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
3 years, 3 months, 1 days
Research summary
Summary of Research
Eczema Care Online (ECO: can online toolkits help people manage their eczema effectively and improve outcomes?
Background
Eczema is a common skin disorder causing itchy skin and dryness. Eczema leads to poor quality of life (sore or bleeding skin, itching and poor sleep). Most people benefit from two treatments: moisturisers (emollients) and topical corticosteroids. Commonly, if eczema is not well-controlled it is because treatments are not used regularly. There are many reasons for this, including that people often receive insufficient or conflicting advice about how to use treatments.Study design
We have developed online toolkits to help parents/carers of children with eczema and young people with eczema manage their condition effectively. The toolkits include information about treatments, infections, diet and allergy, sleep and itch, and managing eczema at school or work. We aim to test the effectiveness of these toolkits in two studies: one for parents / carers of children with eczema and one for young people with eczema.What is involved for participants?
Families of children with eczema (aged 0-12 years) and young people with eczema (aged 13-25 years) will be invited to take part through their GP surgeries. All participants will continue with their normal eczema treatments during the study (i.e. ‘usual care’). Participants will register and consent online and complete a questionnaire before being allocated by chance (randomly) to either ‘study website plus usual care’, or ‘usual care alone’. Participants will be asked to complete a short 4-weekly questionnaire and a longer questionnaire after 24 and 52 weeks. The ‘usual care alone’ group will receive access to the intervention after 52 week follow-up, i.e. 12 months after recruitment.What are the potential benefits of this research?
If the study websites are shown to be effective, health professionals will be encouraged to prescribe them as part of standard care.Summary of Results
Eczema Care Online (ECO): two randomised controlled trials of online interventions to support self-care for eczema for young people with eczema and for parents of children with eczema
Background
Eczema is very common and can have substantial impact on quality of life. A common reason why eczema is not well-controlled is because treatments are not used enough. There are many reasons for this, but one is that people receive insufficient or conflicting advice about how and when to use treatments.Methods
We carried out two randomised trials to test the effectiveness of online toolkits aimed at supporting eczema self-management: one for parents/carers of children aged 0-12 years and one for young people aged 13-25 years. People were invited to join the studies by their GPs and randomly assigned to two groups. One group had access to the Eczema Care Online toolkit for one year in addition to usual care and the other group received usual care only. Online toolkits were made available to the usual care group at the end of the trial.Eczema control was measured every month using the patient-oriented eczema measure (POEM, scores 0-7 mild, 8-16 moderate, 17-28 severe). The primary outcome was to compare POEM between groups over 6 months.
Findings
677 people joined the trials: 340 parents/carers and 337 young people.After taking account of eczema severity and other factors that could have affected the results, the eczema severity (POEM) score was 1.5 points worse in the usual care group than in the toolkit group at 6 months amongst children with eczema. The changes were similar for young people with eczema and these differences persisted at 12 months for both trials. While we were hoping to detect a difference of 2.5 points between groups, it was a positive and persistent result that was statistically significant. Enablement (how well people feel able to cope with the condition), showed an important difference in favour of the toolkit group in both trials.
One of the reasons that a larger difference wasn't observed could be that the toolkits benefitted some but not all users. We looked at how many people achieved a POEM difference of 2.5 points at 24 weeks. Amongst parents/carers of children with eczema, 39% in the usual care group and 58% in the toolkit group reported this difference and for young people the difference was 39% vs 56%.
Online toolkits to support self-management for eczema led to improvements in eczema outcomes.
People who were given the toolkits showed greater improvement in eczema at 6 months and 12 months than people who didn't receive the toolkits.
Implications for practice and future research
Online toolkits for eczema self-management enable young people and parents/carers of children to manage eczema. Online toolkits provide a useful, sustained benefit in eczema severity over 12 months.
It is important to note that the Eczema Care Online toolkits were offered to the intervention group in addition to usual eczema care and therefore should be viewed as supplementing rather than replacing health professional support.
Some aspects of the Eczema Care Online interventions are specific to the UK, such as available treatments and support for navigating health services, yet the intervention could readily be adapted to other settings.
Conclusions
Our online interventions for eczema self-management provide a useful, sustained benefit in managing eczema severity in both children and young people when offered in addition to usual eczema care.What is already known on this subject
• People with eczema and their families often report they have been given insufficient or conflicting information about the condition or how to manage it.
• Group education delivered by multidisciplinary teams has been shown to improve eczema outcomes but is expensive and time-consuming to deliver.
• The effectiveness of online self-management support for eczema has not been assessed in adequately powered trials.What this study adds
• Online interventions providing evidence-based support for eczema self-management led to a useful, sustained benefit in eczema severity over 6 and 12 months in children and young people.
• This small but meaningful improvement is particularly valuable given the low cost and high scalability of the online support and absence of identifiable harms.Reducing the environmental impact of research
These trials have contributed to reducing the carbon footprint of clinical trials: by recruiting participants and delivering the trial interventions entirely online we reduced the paperwork and storage involved in data collection and eliminated travel for study visits.
Patient and public involvement (PPI)
The James Lind Alliance Priority Setting Partnership (PSP) for eczema prioritised the most effective form of eczema education as a key research question. A public contributor who has been involved in supporting eczema management for many years was involved in both the PSP and in the feasibility trial prior to the full-scale trial reported here.
Two public contributors and other members of the Centre of Evidence Based Dermatology Patient Panel were involved from the earliest stages of planning the grant application and subsequently in developing trial recruitment materials and interventions. A public contributor was also a member of the Trial Management Group.
The interventions were co-produced using the Person-Based Approach and with an intervention development group which included public contributors. Once developed, the intervention was further optimised through feedback from a wide range of target users.
Public contributors were involved in study interpretation and planning dissemination of findings. The Independent Trial Steering Committee included representation from key UK eczema charities, also involved in planning dissemination.
Website
The Eczema Care Online website intervention is now freely available without registration at https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.eczemacareonline.org.uk%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ca8aa2b489dbe4b539bcd08dae27e04cc%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638071328116185886%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=aiigQ1jHL%2FOFE1%2F9jFIfv%2BJq%2Ft37gGRzyR2612sPaBA%3D&reserved=0Useful Website Links
Two treatments leaflet: https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.eczemacareonline.org.uk%2Fen%2Ftwo-treatments-documents&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ca8aa2b489dbe4b539bcd08dae27e04cc%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638071328116185886%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=TVE%2BDfOV9voy%2FHfiPC4%2FjIEIHVaWEZGIHBQ%2B1VD1IMs%3D&reserved=0
Website and trial results video link: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbUerPtN23GaUCba3rzolc-2Fi-2FIl5oJcNmH-2BDn-2B3xl5jVBXZ9G8KJy1UPXkS6XAMpBvA-3D-3DKCwz_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJ8qzuLzBBEFySbnWrhu9PpX-2F9ogAz5g9bLgAuduutVWAR440ZpWd0-2B-2B0j50HV0TPEGW4LuczOmucWWo-2FBP4TiXJEauh2JcQBc2bM2stBmf9SIhOyt-2FnfdlcydJLRyGQoRqwfzgUIooPjX0aPnNqiA58kii5xFdFmub0dyo4uk5NA-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ca8aa2b489dbe4b539bcd08dae27e04cc%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638071328116185886%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=rU8DzGm2e40vi2qJwEd4aItoBo3tHxbMOs4rpgaMQNk%3D&reserved=0
Where can I learn more about the study?
Eczema Care Online study information and published papers can be found at https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.nottingham.ac.uk%2FECO&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ca8aa2b489dbe4b539bcd08dae27e04cc%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638071328116185886%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=U1dqLQUWZVRl0Oe8ke%2FNn9xY1AtyGBh0fspedik41gc%3D&reserved=0
Centre of Evidence Based Dermatology (CEBD) ECO Website
https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbYMHrGgxjSYE1anLubeE8B0VkLRzyWE-2BQAoAv-2F6B9sW1srsg3eUik8ASg2EkTDWrOg-3D-3DUijr_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJ8qzuLzBBEFySbnWrhu9PpRt9Rj-2BEk5WILtAyME27lykCEtNkzmOiT3FtQ-2FfTnTtKojeyrZrEqLRKDs-2Fa2LQI-2Bxem8EFSnTvuw4zv2G5YzzCey2aZ8WhSq-2FZ9Lx9qrJt361WM4vCdTSkP0J8-2FniCaJMfWESI4R02sjx9fwHPNX6g-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ca8aa2b489dbe4b539bcd08dae27e04cc%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638071328116185886%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=oArK4yGOxMinf%2BcA%2BRXhg1c0vwlNWtDsrE0RqzlfS48%3D&reserved=0
Acknowledgements
We would like to thank all public contributors, participants, families, practices, the NIHR Clinical Research Network, National Eczema Society, Eczema Outreach Support and the members of the Programme Steering Committee for their support.Sponsor
The University of Southampton was the research sponsor for this trial.REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0351
Date of REC Opinion
24 Oct 2019
REC opinion
Further Information Favourable Opinion