Supporting Parents and Carer's management of Childhood Eczema
| ISRCTN | ISRCTN98560867 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98560867 |
| Secondary identifying numbers | 8427 |
- Submission date
- 04/03/2011
- Registration date
- 04/03/2011
- Last edited
- 29/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Childhood eczema is very common, affecting more than 20% of children aged 5 years or younger at some point. The symptoms can range from mild to severe but usually involves itchy, dry patches of skin. In some cases, the itchiness can be so severe that it interferes with daily life and causes sleep disturbances, which can be extremely distressing for both the child and their family. Healthy skin cells are plumped up with water, which is kept in by natural oils on the skin surface (barrier). If a person has eczema, then the skin often doesn’t produce these oils, leading to loss of moisture and dryness. The main treatments for eczema are emollient creams (moisturisers) and topical corticosteroids (creams or gels containing hormones that reduce inflammation (swelling) which are applied to the skin) in order to prevent flare ups of the condition. Many carers find it difficult to carry out these treatments, as they may not fully understand what the different creams are for and their children may refuse treatment. Carers also need lots of other information, for instance about avoiding things that make eczema worse (such as soap) and how to deal with scratching. The aim of this study is to test the effectiveness of a new internet-based program which offers help and advice to carers of young children with eczema.
Who can participate?
Carers of children under 5 years old who are suffering from eczema.
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group continue to receive usual care and are also given access to the internet-based program for 12 weeks, which includes 14 modules aiming to provide advice and information about caring for children with eczema, such as diet and allergy information, medications, bath time, sleep problems and managing scratching. Those in the second group also receive usual care and access to the internet-based program, but are also given health care professional (HCP) support. This involves phone calls in which the HCP encouraging the participant to use the website. Participants in the third group received usual care only for the 6 months of the study. At the start of the study and again after 6 months, participants complete a number of questionnaires in order to assess whether the way they care for their child’s eczema has changed.
What are the possible benefits and risks of participating?
Participants who have access to the web-based program may find new ways of helping their children, and may be more confident in using different treatments. There are no risks of taking part in this study.
Where is the study run from?
Aldermoor Surgery, Southamptom (UK)
When is the study starting and how long is it expected to run for?
November 2010 to December 2012
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Miriam Santer
m.santer@soton.ac.uk
Contact information
Scientific
Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
| Phone | +44 23 8024 1019 |
|---|---|
| m.santer@soton.ac.uk |
Study information
| Study design | Pilot randomised controlled trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Supporting Parents and Carer's management of Childhood Eczema: development of a web based intervention and pilot randomised controlled trial (RCT) |
| Study acronym | SPaCE |
| Study hypothesis | Objectives 1. Explore the concerns of parents/carers of children with eczema through qualitative interviews. 2. Develop a website based intervention to support self-management amongst parents/carers of children with eczema. 3. Carry out pilot RCT of intervention, examining recruitment, randomisation procedures, response rate, outcome assessment and estimating effect size. 4. Randomise participants to normal care, intervention, intervention plus support from health professional to ascertain whether such support has an impact on intervention effectiveness. Design Development of intervention and pilot feasibility RCT Outcomes This research will allow optimal design of an intervention and provide the necessary information to design a phase 3 trial to test this intervention. If shown to be effective, the intervention would improve quality of life for children with eczema and their families and potentially reduce their risk of progression to other atopic disease. |
| Ethics approval(s) | Berkshire Ethics Committee on 05/08/2010 (ref: 10/H0505/56) |
| Condition | Eczema |
| Intervention | LifeGuide, Internet based behavioural intervention under development; Follow Up Length: 6 month(s); Study Entry : Registration only |
| Intervention type | Other |
| Primary outcome measure | Dermatitis Family Impact questionnaire measured at baseline and 6 months |
| Secondary outcome measures | 1. Infants Dermatology Quality of Life Index measured at baseline and 6 months 2. Patient Oriented Eczema Measure measured at baseline and 6 months |
| Overall study start date | 15/11/2010 |
| Overall study end date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | Planned Sample Size: 180; UK Sample Size: 180 |
| Participant inclusion criteria | 1. Carers of children aged 5 years or less 2. Those whose children have a diagnosis of eczema on their GP record |
| Participant exclusion criteria | 1. Child protection issues 2. Severe mental distress 3. Palliative care 4. Recent bereavement 5. Known opposition to involvement in research or inability to complete research measures, e.g. main carer has learning disability |
| Recruitment start date | 15/11/2010 |
| Recruitment end date | 31/12/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
Sponsor information
University/education
Southampton Primary Care Academic Unit
School of Medicine, Aldermoor Close
Southampton
SO16 5ST
England
United Kingdom
"ROR" |
https://ror.org/01ryk1543 |
|---|
Funders
Funder type
Government
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 | 30/06/2014 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/03/2014 | Yes | No |
Editorial Notes
29/01/2016: Internal review.
