Objective

To determine the effectiveness of two online behavioural interventions, one forparents and carers and one for young people, to support eczemaself-management.

Design

Two independent, pragmatic, parallel group, unmasked, randomised controlledtrials.

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 mildeczema (≤5 on POEM, the Patient-Oriented Eczema Measure).

Interventions

Participants were randomised (1:1) using online software to receive usual eczemacare or an online (www.EczemaCareOnline.org.uk) behavioural intervention for eczemaplus usual care.

Main outcome measures

Primary outcome was eczema symptoms rated using POEM (range 0-28, with 28 beingvery severe) every four weeks over 24 weeks. Outcomes were reported by parents orcarers for children and by self-report for young people. Secondary outcomesincluded POEM score every four weeks over 52 weeks, quality of life, eczemacontrol, itch intensity (young people only), patient enablement, treatment use,perceived barriers to treatment use, and intervention use. Analyses were carriedout separately for the two trials and according to intention-to-treatprinciples.

Results

340 parents or carers of children (169 usual care; 171 intervention) and 337 youngpeople (169 usual care; 168 intervention) were randomised. The mean baseline POEMscore was 12.8 (standard deviation 5.3) for parents and carers and 15.2 (5.4) foryoung people. Three young people withdrew from follow-up but did not withdrawtheir data. All randomised participants were included in the analyses. At 24weeks, 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 andconfounders, compared with usual care groups over 24 weeks, eczema severityimproved 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 2.5difference in POEM score at 24 weeks was 6 in both trials. Improvements weresustained to 52 weeks in both trials. Enablement showed a statisticallysignificant difference favouring the intervention group in both trials: adjustedmean difference at 24 weeks −0.7 (95% confidence interval −1.0 to −0.4) forparents or carers and −0.9 (−1.3 to −0.6) for young people. No harms wereidentified in either group.

Conclusions

Two online interventions for self-management of eczema aimed at parents or carersof children with eczema and at young people with eczema provide a useful,sustained benefit in managing eczema severity in children and young people whenoffered in addition to usual eczema care.

Trial registration

ISRCTN registry ISRCTN79282252.

Setting and participants

Participants were invited through a search of electronic health records and postalinvitation from participating practices around four regional centres: Wessex, West ofEngland, East Midlands, and Thames Valley and South Midlands. Potential participantswere sent an invitation pack containing an information sheet and the study URL toregister if they wished to take part. After registering, participants were asked toprovide informed consent and complete screening and baseline measures online. Forchildren younger than 16 years, the invitation was sent to their parent or carer. Inthe trial for parents and carers, informed consent and questionnaires were completedby the parent or carer. In the trial for young people, parental consent and youngpeople’s assent were sought for participants younger than 16 years, and youngpeople’s consent was sought for participants aged 16 and older. Young people aged13-25 were asked to complete their own questionnaires.

Eligibility for inclusion in the parents and carers trial included being a parent orcarer of a child aged 0-12 years, and eligibility for inclusion in the young peopletrial included being aged 13-25 years. For both trials, inclusion criteria includedchild or young individual having a general practice electronic record code for eczema(any date) and having obtained a prescription for eczema treatment (emollient,topical corticosteroid, or topical calcineurin inhibitor) in the 12 months beforeinvitation to the study. On baseline screening for both trials, potentialparticipants were included if a POEM score >5 was reported. This score thresholdwas used to include those with mild to severe eczema and to exclude those with verymild or inactive eczema to avoid floor effects.²³

For both trials, potential participants were excluded if they were unable to giveinformed consent, were unable to read and write English (as the intervention contentand outcome measures were in English), had taken part in another eczema study in thepast three months, or had no internet access. Only one individual in each householdcould take part in either trial, as intervention content was similar.

Interventions

Outcomes

All participant reported outcome measures were collected online using LifeGuidesoftware.²⁸ Non-responders were sentreminders by phone or SMS (up to two phone calls or up to two SMS, or both). Outcomemeasures were similar across the two trials and followed core outcome measures foreczema recommended in the Harmonising Outcome Measures for Eczema international coreoutcomes set for eczema.²⁹ We did notinclude objective assessment of eczema, however, as this would have requiredface-to-face contact, which could constitute an intervention in its own right andpotentially have greater effect than the online interventions. No changes were madeto trial outcomes.

Sample size

The sample size calculation was based on POEM scores every four weeks using repeatedmeasures from baseline to 24 weeks, seeking to detect a minimum clinically importantdifference of 2.5 (standard deviation 6.5) points between groups. Assuming acorrelation between repeated measures of 0.70, with 90% power and 5% significance,this would give a target sample size of 121 in each group in each of the two trials.Allowing for 20% loss to follow-up resulted in a target sample size of 303 in each ofthe two trials.

Randomisation and masking

Participants were randomised online using LifeGuide software either to usual eczemacare or to online intervention plus usual care. Randomisation was carried out inrandom permuted blocks (sizes 4 and 6) and stratified by age (children 0-5v 6-12 years; young people 13-17v 18-25 years),baseline eczema severity (POEM categories²³6-7 (mild), 8-16 (moderate), 17-28 (severe)), and recruitment region (four regions).It was not possible to mask participants to their allocation group, but their priorbelief in the effectiveness of the online intervention was measured at baseline tominimise potential bias. The trial management group and statisticians remainedblinded to treatment allocation during the conduct of the study and analysis.

Statistical analysis

Analysis was conducted according to a statistical analysis plan agreed in advancewith the independent trial steering committee or data monitoring committee andreported according to CONSORT (consolidated standards of reporting trials)guidelines.³⁹⁴⁰ The two trials (parents or carers, andyoung people) were analysed separately. We used descriptive statistics to comparebaseline characteristics of trial participants by allocated group. The primaryanalyses for the total POEM score used generalised linear mixed models withobservations over time from week 1 to week 24 (level 1) nested within participants(level 2). Our primary outcome is based on adjusted results, controlling for age,baseline POEM score, recruiting centre, sex, ethnicity, prior belief in theintervention, previous use of a website or app for eczema, and parental education (inthe parent and carer trial). We also report unadjusted results for the primaryoutcome.

Participants who had at least one follow-up POEM score between weeks 6 and 24 wereincluded in the primary repeated measures analysis. For all models, participants wereanalysed in the group to which they were randomised, regardless of their adherence tothat allocation (intention-to-treat analysis).

The model used all the observed data and implicitly assumes that, given the observeddata, missing POEM scores were missing at random. The model included a random effectfor centre (random intercept) and patient (random intercept and slope on time) toallow for differences between participants and between centres at baseline anddifferences between participants in the rate of change over time if a treatment-timeinteraction was statistically significant, and fixed effects for baseline covariates.We initially fitted this model (as specified in the statistical analysis plan), butas the intraclass correlation coefficient for regional centre was <0.001, regionalcentre was included as a fixed effect (rather than a random effect) in the finalmodel. An unstructured covariance matrix was used. We examined the structure andpattern of missing data, and multiple imputation was performed as a sensitivityanalysis. The imputation model included all the covariates in the analysis model, aswell as any covariates predictive of missingness. Overall, 100 imputed datasets weregenerated using multiple imputation with chained equations, and the data was analysedusing the same model as for the primary analysis.

For the analysis of secondary outcomes, we used repeated measures analysis for themonthly POEM measure up to 52 weeks consistent with that used for the primaryoutcome. For other secondary outcomes, linear regression was used for continuousoutcomes if the assumptions were met. Logistic regression was used for dichotomousoutcomes. When appropriate, we analysed highly skewed variables as dichotomousoutcomes. All secondary analyses controlled for baseline value, recruiting centre,age, sex, ethnicity, prior belief in the intervention, previous use of a website orapp for eczema, and parental education (in the parent and carer trial). The data wereanalysed using Stata version 16.

Patient and public involvement

The James Lind Alliance Priority Setting Partnership for eczema prioritised the mosteffective form of eczema education as a key research question.⁴¹ Public contributor AR has been involved in supporting eczemamanagement for many years, including through the internet, and was involved in boththe Priority Setting Partnership and in the feasibility trial before the full scaletrial reported here. Public contributors AR, AA, and other members of the Centre ofEvidence Based Dermatology patient panel were involved from the earliest stages ofplanning the grant application and subsequently in developing trial recruitmentmaterials and interventions. AR was a member of the trial management group. Publiccontributors were involved in study interpretation and planning dissemination offindings. The independent trial steering committee included representation from keyeczema charities in the UK, also involved in planning dissemination.

Participant characteristics

Recruitment took place from 2 December 2019 to 8 December 2020, with follow-upcompleted in December 2021. Recruitment was paused in April-May 2020 in response tothe covid-19 pandemic. General practitioners sent invitations to the parents orcarers of 8153 children, and 524 (6.4%) consented online to participate, of whom 340met eligibility criteria and were randomised. Invitations were sent to 5548 youngpeople (or their parent or carer if younger than 16 years), and 411 (7.4%) consentedonline to participate, of whom 337 met eligibility criteria and were randomised;three subsequently withdrew from follow-up.

At 24 weeks (primary time point), POEM was completed by 311/340 (91.5%) parents orcarers and 304/337 (90.2%) young people. At 52 weeks, POEM was completed by 303/340(89.1%) parents or carers and 283/337 (84.0%) young people (fig 1 andfig 2). Participantcharacteristics in both trials were well balanced at baseline (table 1 andtable2).

Primary outcome

Secondary outcomes

POEM scores over 52 weeks showed a persisting benefit for the intervention group,with adjusted mean difference in score of −1.4 (95% confidence interval −2.3 to −0.4)in the trial for parents and carers and −1.4 (−2.4 to −0.4) in the trial for youngpeople (fig 3 andfig 4). In the trial for parents and carers, 48% (74) of participants inthe usual care group and 60% (89) in the intervention group reported an improvementof at least 2.5 points in the POEM score at 52 weeks (adjusted odds ratio 1.4, 95%confidence interval 0.8 to 2.4). In the trial for young people, 47% (70) ofparticipants in the usual care group and 62% (84) in the intervention group reportedan improvement of at least 2.5 points in the POEM score at 52 weeks (adjusted oddsratio 1.6, 0.9 to 2.8).

The only significant difference between groups in secondary outcomes was in thePatient Enablement Instrument, which showed improvements of about 1 point on the 7point scale in the intervention groups in both trials by 24 weeks (table 5 andtable 6): equivalent to a difference from participants in usual care groupfeeling neutral about being helped to manage their eczema to participants in theintervention group reporting that they were now better able to understand, cope with,and manage their eczema. This difference persisted to 52 weeks in both trials (table 5 andtable 6).

Other outcomes did not differ between the groups, including in the ProblematicExperiences of Therapy Scale, although in the parent and carer trial the perceptionof treatments as problematic seemed to be lower in the intervention group, althoughnot statistically significant.

Treatment use was highly skewed and was therefore analysed as a dichotomous variable(7 days versus<7 days for emollient use, and any versus none fortopical corticosteroid and topical calcineurin inhibitor use). No significantdifferences were found between groups in either trial on any of the measures oftreatment use (emollient, topical corticosteroid, topical calcineurin inhibitor)measured at 24 weeks (table 7 andtable 8).

Analysis of completion of core content (predefined minimum effective engagementthreshold) was excellent: data for online intervention usage showed that mostparticipants had completed the core module by 24 weeks: 299/340 (88%) parents andcarers and 310/337 (92%) young people.

Subgroup analyses

Prespecified subgroup analyses in both trials showed that participants allocated tothe intervention group showed similar benefit in eczema outcomes, regardless of age,sex, eczema severity, baseline treatment use, prior belief in effectiveness ofintervention, or previous use of other eczema related websites (see appendix tablesS5 and S6). No harms or unintended effects were identified in either trial.

Strengths and limitations of this study

The two Eczema Care Online trials have several strengths, including long follow-up,high rates of follow-up, broad inclusion criteria and range of eczema severities, andoutcome measures of importance to young people with eczema and carers, leadingoverall to a pragmatic trial and generalisable results.

It was not possible to blind participants to treatment allocation, and this couldhave led to bias in the primary outcome, despite measures to adjust for prior beliefin the intervention to minimise this potential bias in analysis. However, even if acontextual effect (or placebo effect) contributes to improvement in eczema, theeffect is still a valuable benefit to people with eczema and their families,particularly when it improves their ability to cope with the condition.

The improvements in primary outcome (1.5 (95% confidence interval 0.6 to 2.5) forchildren and 1.9 (0.8 to 3.0) for young people) were less than the target of 2.5points on the POEM score. The most recent research on the minimal clinicallyimportant difference for POEM suggests that a range of 2.1 to 2.9 represents a smallchange that is likely to be beyond measurement error, and that a “small improvementin many individuals could result in a large reduction in burden at a societallevel.”²² Our estimates fall below thisbut with narrow confidence intervals that exclude the null hypothesis and include theminimal clinically important difference. However, substantial proportions ofparticipants experienced clinically important improvement: more than half in theintervention group in both trials achieved an improvement at or above the minimalclinically important difference, and the number needed to treat for one participantto benefit compared with usual care was 6 in both trials, which is noteworthy forsuch a low cost intervention.

Recruitment into this trial was through a search of general practice records andpostal invitations to potentially eligible participants. Although this method forrecruitment resulted in a low response rate, it is consistent with other similarstudies,⁴² which means that theinvitation to participate will not always be salient to people because eczema is arelapsing-remitting condition and people are unlikely to respond when in remission.In real world use, the interventions are envisaged as being particularly appropriatearound newly diagnosed eczema or flare-ups, where uptake is likely to be higher andthe intervention could potentially be most effective.

Some of the recruitment and follow-up of participants in this study took place duringthe covid-19 pandemic. Qualitative research carried out during the trial suggestedthat this could have had both positive and negative impacts on participants’eczema.⁴³ For example, it may have madeit harder for participants to access healthcare for some months during the study andto discuss or change their treatments in response to the intervention, although thislack of access may have improved engagement with the online toolkits.

Comparison with other studies

Few fully powered trials have been carried out of self-management or educationalinterventions for eczema, and those that have been published used different outcomemeasures, making direct comparisons challenging. However, much more costlyeducational interventions have only shown modest improvements in eczema, and webelieve the effect size in our trials compares favourably with more intensiveinterventions.

In some contexts, the effectiveness of online interventions has been shown to beenhanced by health professional support, and this was tested in a feasibility studybefore this trial.¹⁵ In the three armfeasibility study, 143 parents or carers of children with eczema were randomised to:usual care alone; an online intervention plus usual care; or an online interventionplus 20 minutes of health professional support (primarily practice nurses) and usualcare. In the feasibility study, health professional support did not lead to betteroutcomes, and process evaluation indicated that the health professional support wasnot highly valued by participants in this context, and it was therefore not includedin the full scale trial reported here.

Implications for practice and future research

As 90% of people with eczema are managed in primary care in the UK, further researchis needed to explore the impact of online interventions in healthcare settings wheresecondary care management is more common or where patient support for eczema is moreextensive. Although some aspects of the Eczema Care Online interventions are specificto the UK, such as available treatments and support for navigating health services,the intervention could readily be adapted to other settings.

Conclusions

Eczema Care Online interventions for parents and carers of children with eczema andfor young people with eczema are evidence based resources that have been shown tohelp young people better understand, cope with, and manage their eczema, and offer auseful benefit in clinical outcomes, sustained over 52 weeks. A small amount ofbenefit at low cost with no identifiable harms for a condition that affects a largenumber of people can lead to substantial health benefit for the public in absoluteterms. The findings reinforce the key role of health professionals in signpostingpatients and carers towards self-management support for long term conditions.

Ethical approval

The trials were approved by South Central-Oxford A Research Ethics Committee(19/SC/0351).

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Supplementary Materials

Data Availability Statement

Consent was not obtained from participants for data sharing. Authors will considerreasonable request to make relevant anonymised participant level data available.