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Eczema Care Online behavioural interventions to support self-care for children and young people: two independent, pragmatic, randomised controlled trials

Eczema Care Online behavioural interventions to support self-care for children and young people: two independent, pragmatic, randomised controlled trials
Eczema Care Online behavioural interventions to support self-care for children and young people: two independent, pragmatic, randomised controlled trials

Abstract:Objective: To determine the effectiveness of two online behavioural interventions, one for parents and carers and one for young people, to support eczema self-management. Design: Two independent, pragmatic, parallel group, unmasked, randomised controlled trials. Setting: 98 general practices in England. Participants: Parents and carers of children (0-12 years) with eczema (trial 1) and young people (13-25 years) with eczema (trial 2), excluding people with inactive or very mild eczema (≤5 on POEM, the Patient-Oriented Eczema Measure). Interventions: Participants were randomised (1:1) using online software to receive usual eczema care or an online (www.EczemaCareOnline.org.uk) behavioural intervention for eczema plus usual care. Main outcome measures: Primary outcome was eczema symptoms rated using POEM (range 0-28, with 28 being very severe) every four weeks over 24 weeks. Outcomes were reported by parents or carers for children and by self-report for young people. Secondary outcomes included POEM score every four weeks over 52 weeks, quality of life, eczema control, itch intensity (young people only), patient enablement, treatment use, perceived barriers to treatment use, and intervention use. Analyses were carried out separately for the two trials and according to intention-to-treat principles. Results: 340 parents or carers of children (169 usual care; 171 intervention) and 337 young people (169 usual care; 168 intervention) were randomised. The mean baseline POEM score was 12.8 (standard deviation 5.3) for parents and carers and 15.2 (5.4) for young people. Three young people withdrew from follow-up but did not withdraw their data. All randomised participants were included in the analyses. At 24 weeks, follow-up rates were 91.5% (311/340) for parents or carers and 90.2% (304/337) for young people. After controlling for baseline eczema severity and confounders, compared with usual care groups over 24 weeks, eczema severity improved in the intervention groups: mean difference in POEM score -1.5 (95% confidence interval -2.5 to -0.6; P=0.002) for parents or carers and -1.9 (-3.0 to -0.8; P<0.001) for young people. The number needed to treat to achieve a 2.5 difference in POEM score at 24 weeks was 6 in both trials. Improvements were sustained to 52 weeks in both trials. Enablement showed a statistically significant difference favouring the intervention group in both trials: adjusted mean difference at 24 weeks -0.7 (95% confidence interval -1.0 to -0.4) for parents or carers and -0.9 (-1.3 to -0.6) for young people. No harms were identified in either group. Conclusions: Two online interventions for self-management of eczema aimed at parents or carers of children with eczema and at young people with eczema provide a useful, sustained benefit in managing eczema severity in children and young people when offered in addition to usual eczema care. Trial registration: ISRCTN registry ISRCTN79282252.

Adolescent, Child, Humans, Caregivers, Cost-Benefit Analysis, Eczema/therapy, Internet-Based Intervention, Quality of Life, Self Care, Telemedicine
0959-8138
e072007
Santer, Miriam
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Muller, Ingrid
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Becque, Taeko
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Stuart, Beth
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Hooper, Julie
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Steele, Mary
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Wilczynska, Sylvia
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Sach, Tracey H
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Ridd, Matthew J.
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Roberts, Amanda
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Ahmed, Amina
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Yardley, Lucy
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Little, Paul
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Greenwell, Kate
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Sivyer, Katy
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Nuttall, Jacqueline
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Griffiths, Gareth
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Lawton, Sandra
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Langan, Sinéad
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Howells, Laura M
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Leighton, Paul
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Williams, Hywel
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Thomas, Kim S.
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Santer, Miriam
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Muller, Ingrid
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Becque, Taeko
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Stuart, Beth
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Hooper, Julie
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Steele, Mary
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Wilczynska, Sylvia
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Sach, Tracey H
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Ridd, Matthew J.
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Roberts, Amanda
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Ahmed, Amina
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Yardley, Lucy
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Little, Paul
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Greenwell, Kate
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Sivyer, Katy
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Nuttall, Jacqueline
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Griffiths, Gareth
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Lawton, Sandra
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Langan, Sinéad
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Howells, Laura M
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Leighton, Paul
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Williams, Hywel
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Thomas, Kim S.
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Santer, Miriam, Muller, Ingrid, Becque, Taeko, Stuart, Beth, Hooper, Julie, Steele, Mary, Wilczynska, Sylvia, Sach, Tracey H, Ridd, Matthew J., Roberts, Amanda, Ahmed, Amina, Yardley, Lucy, Little, Paul, Greenwell, Kate, Sivyer, Katy, Nuttall, Jacqueline, Griffiths, Gareth, Lawton, Sandra, Langan, Sinéad, Howells, Laura M, Leighton, Paul, Williams, Hywel and Thomas, Kim S. (2022) Eczema Care Online behavioural interventions to support self-care for children and young people: two independent, pragmatic, randomised controlled trials. The BMJ, 379, e072007, [e072007]. (doi:10.1136/bmj-2022-072007).

Record type: Article

Abstract

Abstract:Objective: To determine the effectiveness of two online behavioural interventions, one for parents and carers and one for young people, to support eczema self-management. Design: Two independent, pragmatic, parallel group, unmasked, randomised controlled trials. Setting: 98 general practices in England. Participants: Parents and carers of children (0-12 years) with eczema (trial 1) and young people (13-25 years) with eczema (trial 2), excluding people with inactive or very mild eczema (≤5 on POEM, the Patient-Oriented Eczema Measure). Interventions: Participants were randomised (1:1) using online software to receive usual eczema care or an online (www.EczemaCareOnline.org.uk) behavioural intervention for eczema plus usual care. Main outcome measures: Primary outcome was eczema symptoms rated using POEM (range 0-28, with 28 being very severe) every four weeks over 24 weeks. Outcomes were reported by parents or carers for children and by self-report for young people. Secondary outcomes included POEM score every four weeks over 52 weeks, quality of life, eczema control, itch intensity (young people only), patient enablement, treatment use, perceived barriers to treatment use, and intervention use. Analyses were carried out separately for the two trials and according to intention-to-treat principles. Results: 340 parents or carers of children (169 usual care; 171 intervention) and 337 young people (169 usual care; 168 intervention) were randomised. The mean baseline POEM score was 12.8 (standard deviation 5.3) for parents and carers and 15.2 (5.4) for young people. Three young people withdrew from follow-up but did not withdraw their data. All randomised participants were included in the analyses. At 24 weeks, follow-up rates were 91.5% (311/340) for parents or carers and 90.2% (304/337) for young people. After controlling for baseline eczema severity and confounders, compared with usual care groups over 24 weeks, eczema severity improved in the intervention groups: mean difference in POEM score -1.5 (95% confidence interval -2.5 to -0.6; P=0.002) for parents or carers and -1.9 (-3.0 to -0.8; P<0.001) for young people. The number needed to treat to achieve a 2.5 difference in POEM score at 24 weeks was 6 in both trials. Improvements were sustained to 52 weeks in both trials. Enablement showed a statistically significant difference favouring the intervention group in both trials: adjusted mean difference at 24 weeks -0.7 (95% confidence interval -1.0 to -0.4) for parents or carers and -0.9 (-1.3 to -0.6) for young people. No harms were identified in either group. Conclusions: Two online interventions for self-management of eczema aimed at parents or carers of children with eczema and at young people with eczema provide a useful, sustained benefit in managing eczema severity in children and young people when offered in addition to usual eczema care. Trial registration: ISRCTN registry ISRCTN79282252.

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More information

Accepted/In Press date: 2022
Published date: 8 December 2022
Additional Information: Funding Information: Funding: This study presents independent research funded by the National Institute for Health and Care Research (NIHR) under its Programme Grants for Applied Research programme (RP-PG-0216-20007). The funders had no role in the collection, analysis, interpretation of data, writing of the report, or decision to submit the article for publication. Eczema Care Online interventions were developed using LifeGuide software, which was partly funded by the NIHR Southampton Biomedical Research Centre. SiL was supported by a Wellcome senior research fellowship in clinical science (205039/Z/16/Z). The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health and Social Care. The University of Southampton was the research sponsor for this trial. Funding Information: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: no support from any organisation other than the National Institute for Health and Care Research for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work, other than LH has received consultancy fees from the University of Oxford on an educational grant funded by Pfizer, unrelated to the submitted work. Publisher Copyright: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.
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Keywords: Adolescent, Child, Humans, Caregivers, Cost-Benefit Analysis, Eczema/therapy, Internet-Based Intervention, Quality of Life, Self Care, Telemedicine

Identifiers

Local EPrints ID: 473180
URI: http://eprints.soton.ac.uk/id/eprint/473180
ISSN: 0959-8138
PURE UUID: fd75b9b6-e5dd-4b98-bbc3-2e2442790485
ORCID for Miriam Santer: ORCID iD orcid.org/0000-0001-7264-5260
ORCID for Ingrid Muller: ORCID iD orcid.org/0000-0001-9341-6133
ORCID for Taeko Becque: ORCID iD orcid.org/0000-0002-0362-3794
ORCID for Beth Stuart: ORCID iD orcid.org/0000-0001-5432-7437
ORCID for Mary Steele: ORCID iD orcid.org/0000-0003-2595-3855
ORCID for Tracey H Sach: ORCID iD orcid.org/0000-0002-8098-9220
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X
ORCID for Paul Little: ORCID iD orcid.org/0000-0003-3664-1873
ORCID for Kate Greenwell: ORCID iD orcid.org/0000-0002-3662-1488
ORCID for Katy Sivyer: ORCID iD orcid.org/0000-0003-4349-0102
ORCID for Gareth Griffiths: ORCID iD orcid.org/0000-0002-9579-8021

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Date deposited: 11 Jan 2023 17:55
Last modified: 11 Jul 2024 02:14

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Contributors

Author: Miriam Santer ORCID iD
Author: Ingrid Muller ORCID iD
Author: Taeko Becque ORCID iD
Author: Beth Stuart ORCID iD
Author: Julie Hooper
Author: Mary Steele ORCID iD
Author: Sylvia Wilczynska
Author: Tracey H Sach ORCID iD
Author: Matthew J. Ridd
Author: Amanda Roberts
Author: Amina Ahmed
Author: Lucy Yardley ORCID iD
Author: Paul Little ORCID iD
Author: Kate Greenwell ORCID iD
Author: Katy Sivyer ORCID iD
Author: Jacqueline Nuttall
Author: Sandra Lawton
Author: Sinéad Langan
Author: Laura M Howells
Author: Paul Leighton
Author: Hywel Williams
Author: Kim S. Thomas

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