Supporting self-care for eczema: protocol for two randomised controlled trials of ECO (Eczema Care Online) interventions for young people and parents/carers
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 (RCTs) aimed to ev...
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BMJ Publishing Group
2021-02-01
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| author | Ingrid Muller Miriam Santer Taeko Becque Beth Stuart Paul Little Matthew J Ridd Joanne R Chalmers Lucy Yardley Paul Leighton Amanda Roberts Hywel C Williams Julie Hooper Kate Greenwell Sinéad M Langan Kim S Thomas Gareth Griffiths Sandra Lawton Jacqui Nuttall Tracey Sach Sylvia Wilczynska Mary Steele Katy Sivyer Laura M Howells Amina Ahmed Hayden Kirk |
| author_facet | Ingrid Muller Miriam Santer Taeko Becque Beth Stuart Paul Little Matthew J Ridd Joanne R Chalmers Lucy Yardley Paul Leighton Amanda Roberts Hywel C Williams Julie Hooper Kate Greenwell Sinéad M Langan Kim S Thomas Gareth Griffiths Sandra Lawton Jacqui Nuttall Tracey Sach Sylvia Wilczynska Mary Steele Katy Sivyer Laura M Howells Amina Ahmed Hayden Kirk |
| author_sort | Ingrid Muller |
| collection | DOAJ |
| description | 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 (RCTs) aimed to evaluate clinical and cost-effectiveness of the two interventions.Methods and analysis Design: Two independent, pragmatic, unmasked, parallel group RCTs with internal pilots and nested health economic and process evaluation studies. Setting: Participants will be recruited from general practitioner practices in England. Participants: Young people aged 13–25 years with eczema and parents and carers of children aged 0–12 years with eczema, excluding inactive or very mild eczema (five 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 a National Health Service and personal social service perspective. Qualitative and quantitative process evaluation will help understand the 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 policy makers.Trial registration number ISRCTN79282252. |
| format | Article |
| id | doaj-art-b1f2211a33db42e89bbf56d17a72362c |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-02-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-b1f2211a33db42e89bbf56d17a72362c2024-11-17T04:55:08ZengBMJ Publishing GroupBMJ Open2044-60552021-02-0111210.1136/bmjopen-2020-045583Supporting self-care for eczema: protocol for two randomised controlled trials of ECO (Eczema Care Online) interventions for young people and parents/carersIngrid Muller0Miriam Santer1Taeko Becque2Beth Stuart3Paul Little4Matthew J Ridd5Joanne R Chalmers6Lucy Yardley7Paul Leighton8Amanda Roberts9Hywel C Williams10Julie Hooper11Kate Greenwell12Sinéad M Langan13Kim S Thomas14Gareth Griffiths15Sandra Lawton16Jacqui Nuttall17Tracey Sach18Sylvia Wilczynska19Mary Steele20Katy Sivyer21Laura M Howells22Amina Ahmed23Hayden Kirk242 Primary Care Research Centre, School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UKPrimary Care Research Centre, University of Southampton, Southampton, UK2 Primary Care Research Centre, School of Primary Care, Population Science, and Medical Education, University of Southampton, Southampton, UK2 Queen Mary University of London, London, UKPrimary Care Research Centre, University of Southampton Faculty of Medicine, Southampton, UKPopulation Health Sciences, University of Bristol, Bristol, UKCentre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UKBristol Medical School, University of Bristol, Bristol, UK2 School of Medicine, University of Nottingham, Nottingham, UKSchool of Psychology, University of Lincoln, Lincoln, UKLifespan and Population Health, University of Nottingham, Nottingham, UKtrial managerUniversity Of Southampton, Southampton, UK1 London School of Hygiene & Tropical Medicine, London, UK5 Centre for Evidence Based Dermatology, University of Nottingham, Nottingham, UK3 Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UKnurse consultant dermatology11 Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UKprofessor of health economicstrial managerresearch fellowresearch fellowresearch fellowpatient and public contributorAdult Services, Solent NHS Trust, Southampton, UKIntroduction 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 (RCTs) aimed to evaluate clinical and cost-effectiveness of the two interventions.Methods and analysis Design: Two independent, pragmatic, unmasked, parallel group RCTs with internal pilots and nested health economic and process evaluation studies. Setting: Participants will be recruited from general practitioner practices in England. Participants: Young people aged 13–25 years with eczema and parents and carers of children aged 0–12 years with eczema, excluding inactive or very mild eczema (five 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 a National Health Service and personal social service perspective. Qualitative and quantitative process evaluation will help understand the 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 policy makers.Trial registration number ISRCTN79282252.https://bmjopen.bmj.com/content/11/2/e045583.full |
| spellingShingle | Ingrid Muller Miriam Santer Taeko Becque Beth Stuart Paul Little Matthew J Ridd Joanne R Chalmers Lucy Yardley Paul Leighton Amanda Roberts Hywel C Williams Julie Hooper Kate Greenwell Sinéad M Langan Kim S Thomas Gareth Griffiths Sandra Lawton Jacqui Nuttall Tracey Sach Sylvia Wilczynska Mary Steele Katy Sivyer Laura M Howells Amina Ahmed Hayden Kirk 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 |
| title | Supporting self-care for eczema: protocol for two randomised controlled trials of ECO (Eczema Care Online) interventions for young people and parents/carers |
| title_full | Supporting self-care for eczema: protocol for two randomised controlled trials of ECO (Eczema Care Online) interventions for young people and parents/carers |
| title_fullStr | Supporting self-care for eczema: protocol for two randomised controlled trials of ECO (Eczema Care Online) interventions for young people and parents/carers |
| title_full_unstemmed | Supporting self-care for eczema: protocol for two randomised controlled trials of ECO (Eczema Care Online) interventions for young people and parents/carers |
| title_short | Supporting self-care for eczema: protocol for two randomised controlled trials of ECO (Eczema Care Online) interventions for young people and parents/carers |
| title_sort | supporting self care for eczema protocol for two randomised controlled trials of eco eczema care online interventions for young people and parents carers |
| url | https://bmjopen.bmj.com/content/11/2/e045583.full |
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