Eczema care online
| ISRCTN | ISRCTN79282252 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79282252 |
| Secondary identifying numbers | 42660 |
- Submission date
- 25/11/2019
- Registration date
- 28/11/2019
- Last edited
- 10/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
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 with eczema benefit from two treatments: (1) moisturisers (emollients) for dry skin, which need to be applied daily; and (2) topical corticosteroids for inflamed skin and eczema flares. Commonly, if eczema is not well-controlled it is because treatments are not used appropriately. There are many reasons why people may find it difficult to use eczema treatments: they can be time-consuming to apply; treatments may sting when first applied to inflamed skin; there are concerns about the safety of some treatments; and because people often receive conflicting or insufficient advice about how and when to use treatments.
The trialists have developed online toolkits to help parents/carers of children with eczema (aged 0-12 years) and young people with eczema (aged 13-25 years) manage eczema more effectively. Toolkits cover a range of topics relevant to people with eczema. The aim of this study is to test the effectiveness and cost-effectiveness of these online toolkits in two studies: one for parents/carers of children with eczema and one for young people with eczema.
Who can participate?
Participants will be invited to take part if they are either: (1) a young person aged 13-25 years with eczema; or (2) a parent/carer of a child aged 0-12 years with eczema. The participant must be able to access the internet and the eczema must be mild, moderate or severe but not very mild.
What does the study involve?
Parents/carers and young people with eczema will be invited to take part in the studies through their GP surgeries. Participants will be asked to register online and complete an online consent form and baseline questionnaire before being allocated by chance (randomly) to either the group who will use the online toolkit, or to the group who will receive their usual care. All participants will continue with their normal eczema treatments during the study. All participants will be asked to fill in a very short 4-weekly questionnaire about their eczema and a longer questionnaire after 24 weeks and 52 weeks. Participants in the group receiving usual care will get access to the online toolkit after 52 week follow-up.
What are the possible benefits and risks of participating?
The research participants benefit from access to the ECO website which provides support for self-management of eczema. Participants in the treatment group will access the website immediately while participants in the control group will have access to this 12 months after they sign up. It is not anticipated there are any risks for the participants.
If the study websites are effective, health professionals will be encouraged to prescribe them as part of standard care.
Where is the study run from?
The University of Southampton, UK
When is the study starting and how long is it expected to run for?
December 2019 to January 2022
Who is funding the study?
National Institute for Health Research (NIHR), UK
Who is the main contact?
1. Julie Hooper (public)
j.hooper@soton.ac.uk
2. Dr Miriam Santer (scientific)
m.santer@soton.ac.uk
Contact information
Public
Primary Care, Population Sciences & Medical Education
The University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
 ORCID ID |
0000-0001-6580-6150 |
|---|---|
| Phone | +44 (0)23 8059 1742 |
| j.hooper@soton.ac.uk |
Scientific
Primary Care, Population Sciences & Medical Education
The University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| ORCID ID |
0000-0001-7264-5260 |
|---|---|
| Phone | +44(0) 2380 591789 |
| m.santer@soton.ac.uk |
Study information
| Study design | Randomized; Both; Design type: Screening, Psychological & Behavioural, Management of Care, Active Monitoring, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific 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 |
| Study acronym | ECO |
| Study hypothesis | Online interventions supporting eczema self-care can lead to improved outcomes for people with eczema. |
| Ethics approval(s) | Approved 25/10/2019, (South Central – Oxford A Research Ethics Committee, Whitefriars, Level 3 Block B, Lewins Mead, Bristol, BS1 2NT, UK; nrescommittee.southcentral-oxforda@nhs.net; +44(0)207 104 8048), ref: 19/SC/0351 |
| Condition | Dermatitis and eczema |
| Intervention | Two trials (trial-YP and trial-PC) of two online behavioural interventions will be carried out. Intervention-YP is for young people aged 13-25 with eczema and intervention-PC is for parents/carers of children with eczema aged 0-12. The interventions were developed using the Person-Based Approach, are evidence based, and draw on theoretical frameworks. They cover a wide range of topics and are designed to support self-management of eczema. The majority of study procedures will be carried out online through the intervention websites (developed using LifeGuide software). Participants wishing to take part in the study will provide consent or assent (where required) and complete an online baseline questionnaire as indicated in the schedule of observations before being randomised to either the intervention group or the control group. Intervention arm: Participants in the intervention group will then have access to the intervention website (either intervention-YP or intervention-PC, depending on which trial they are in). Control arm: Participants in the control group will be given access to the intervention website after 52 week follow-up. All participants will be asked to complete a 4-weekly POEM measure online for a period of 52 weeks. Participants will also be asked to complete a 24 week and 52 week follow-up questionnaire online. Automated emails and text messages will be sent to notify participants when their follow-up questionnaires are available for completion. Reminder emails and texts will be sent to non-responders after 3 days followed by reminder telephone calls approximately 3 days later from the research team, at which point participants will be invited to complete follow-up questions over the phone. Using purposive sampling, we will select a number of participants from both groups to be invited to take part in a qualitative interview 3 months after randomisation. Randomisation: Randomisation will be automated by the Lifeguide software. It will be carried out in blocks and stratified by age e.g. 13-17; 18-25 (trial-YP), and 0-5; 6-12 (trial-PC), baseline eczema severity (POEM scores 6-7; 8-16; 17-28) and recruitment site as these may influence how participants engage with the interventions. |
| Intervention type | Behavioural |
| Primary outcome measure | The primary outcome measures for both trials will be eczema severity over 24 weeks measured by 4-weekly POEM (Patient-Oriented Eczema Measure) |
| Secondary outcome measures | 1. Eczema severity will be measured using the POEM (Patient-Oriented Eczema Measure) 4-weekly from week 0 to 52-week follow-up (corrected/moved from the primary outcome measures 23/09/2020) 2. Quality of Life will be measured in both trials: 2.1. In trial-YP, Quality of Life will be measured using the EQ-5D-5L self-completed by the young person, at baseline, 24-week and 52-week follow-up 2.2. In trial-PC, Quality of Life will be measured by proxy using the Child Health Utility - Nine Dimensions (CHU-9D) for those children aged 2 to 12 years, at baseline, 24-week and 52-week follow-up 3. Long-term control will be measured by RECAP (Recap for atopic eczema patients), at baseline, 24-week and 52-week follow-up 4. Itch intensity measure (worst itch in last 24 hours) measured using Itch intensity single item (only validated for adults). In Trial-YP but not for Trial-PC., at baseline, 24-week and 52-week follow-up 5. Enablement, the self-perceived ability to understand and cope with health issues, will be measured using the Patient Enablement Instrument (PEI), at baseline, 24-week and 52-week follow-up 6. Health service use and medication use will be measured by medical notes review, during the 3 month period prior to baseline and the whole 52 week trial period 7. Cost-effectiveness combining quality of life and health service use and medication use, during the 3 month period prior to baseline and the whole 52 week trial period 8. Prior belief about the effectiveness of the intervention measured using self-report at baseline 9. Online resource use (websites or apps) for eczema measured using self-report at baseline 10. Self-reported barriers to adherence will be measured using the Problematic Experiences of Therapy Scale (PETS), at baseline, 24-week and 52-week follow-up 11. Frequency of treatment use (emollients, topical steroids, and topical calcineurin inhibitors) over the past week will be measured by self-report, at baseline, 24-week and 52-week follow-up 12. Intervention usage (e.g. number of visits, time spent on the website, pages visited) will automatically be recorded by LifeGuide software for each participant over the whole 52 week trial period |
| Overall study start date | 01/03/2019 |
| Overall study end date | 31/01/2022 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | Planned sample size: minimum of 200 for trial-PC and minimum of 200 for trial-YP; UK sample size: minimum of 200 for trial-PC and minimum of 200 for trial-YP |
| Total final enrolment | 677 |
| Participant inclusion criteria | Trial-YP: 1. Young person aged 13-25 years with eczema 2. Identified from GP records as having eczema and have obtained a prescription for eczema treatment in the past 12 months 3. POEM score greater than 5 to include mild to severe eczema, but exclude those with very mild eczema to avoid floor effects 4. Internet access Trial-PC: 1. Parent / carer of a child aged 0-12 years with eczema 2. Child was identified from GP records as having eczema and has obtained a relevant prescription in the past 12 months 3. Child has a POEM score greater than 5 to include mild to severe eczema, but exclude those with very mild eczema 4. Have internet access Only 1 person per household will be able to take part in each trial. If a parent / carer in trial-PC has more than one child who meets the inclusion criteria they will be asked to specify one child to participate in the trial. |
| Participant exclusion criteria | 1. Unable to give informed consent 2. Unable to read and write English as the intervention content and outcome measures are in English 3. Taken part in another eczema intervention in the past 3 months. 4. Took part in think-aloud interviews as part of ECO intervention development. (Qualitative interviewees who did not view intervention materials will NOT be excluded) |
| Recruitment start date | 02/12/2019 |
| Recruitment end date | 29/11/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
SO40 2RZ
United Kingdom
SO19 8BR
United Kingdom
SO30 2UN
United Kingdom
LE1 5WW
United Kingdom
BS1 2NT
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
University/education
Research Governance Office
Room 2029, Building 28, Highfield Campus
Southampton
SO17 1BJ
England
United Kingdom
| Phone | +44 (0) 2380 598580 |
|---|---|
| rgoinfo@soton.ac.uk | |
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Current publication and dissemination plan as of 24/01/2022: Planned publication in a high-impact peer-reviewed journal Intervention development paper: young people - 31 May 2022 Intervention development paper: parents/carers – 31 May 2022 Trial protocol – 2020 Trial paper – 2023 Health economic paper – 2023 Process evaluation paper – 2023 Previous publication and dissemination plan: Planned publication in a high-impact peer-reviewed journal Intervention development paper: young people - 2020 Intervention development paper: parents/carers – 2020 Trial protocol – 2020 Trial paper – 2023 Health economic paper – 2023 Process evaluation paper – 2023 |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the difficulty in anonymising it. We shall make quantitative data available with as few restrictions as feasible, while retaining exclusive use until the publication of major outputs. Anonymised data may be deposited in a data repository at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 05/02/2021 | 09/02/2021 | Yes | No |
| Protocol file | version 4 | 08/10/2020 | 12/10/2022 | No | No |
| Statistical Analysis Plan | 12/10/2022 | No | No | ||
| Other files | Health economic analysis plan version 1.0 |
07/11/2022 | No | No | |
| Results article | 08/12/2022 | 13/12/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | within-trial economic evaluation results | 09/01/2024 | 10/01/2024 | Yes | No |
Additional files
- ISRCTN79282252_PROTOCOL_V4_08Oct20.pdf
- ISRCTN79282252_SAP.pdf
- ISRCTN79282252_HEAP_V1.0.pdf
- Health economic analysis plan
Editorial Notes
10/01/2024: Publication reference added.
13/12/2022: Publication reference added.
07/11/2022 Uploaded health economic analysis plan.
12/10/2022: Uploaded statistical analysis plan and protocol (not peer reviewed).
24/01/2022: The following changes have been made:
1. The intention to publish date has been changed from 31/12/2023 to 31/12/2022.
2. The total final enrolment number has been changed from 678 to 677.
3. The publication and dissemination plan has been updated.
15/06/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2021 to 29/11/2020.
2. The overall trial end date has been changed from 30/12/2022 to 31/01/2022 and the plain English summary has been updated to reflect this change.
3. The total final enrolment number has been added.
09/02/2021: Publication reference added.
23/09/2020: The secondary outcome measures were updated.
10/09/2020: NIHR CRN Thames Valley and South Midlands added as a trial participating centre. The target number of participants was changed from '400' to 'Planned sample size: minimum of 200 for trial-PC and minimum of 200 for trial-YP; UK sample size: minimum of 200 for trial-PC and minimum of 200 for trial-YP'.
29/11/2019: Internal review.
27/11/2019: Trial’s existence confirmed by the National Institute for Health Research (NIHR).
