Condition category
Skin and Connective Tissue Diseases
Date applied
04/03/2011
Date assigned
04/03/2011
Last edited
29/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Miriam Santer

ORCID ID

Contact details

Primary Medical Care
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 23 8024 1019
m.santer@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8427

Study information

Scientific title

Supporting Parents and Carer's management of Childhood Eczema: development of a web based intervention and pilot randomised controlled trial (RCT)

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

Berkshire Ethics Committee on 05/08/2010 (ref: 10/H0505/56)

Study design

Pilot randomised controlled trial

Primary study design

Observational

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Eczema

Intervention

LifeGuide, Internet based behavioural intervention under development; Follow Up Length: 6 month(s); Study Entry : Registration only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

15/11/2010

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 180; UK Sample Size: 180

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

United Kingdom

Trial participating centre

Aldermoor Surgery
Primary Medical Care Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

Southampton Primary Care Academic Unit
School of Medicine
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

30/06/2014

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24594972

Publication citations

  1. Results

    Santer M, Muller I, Yardley L, Burgess H, Selinger H, Stuart BL, Little P, Supporting self-care for families of children with eczema with a Web-based intervention plus health care professional support: pilot randomized controlled trial., J. Med. Internet Res., 2014, 16, 3, e70, doi: 10.2196/jmir.3035.

Additional files

Editorial Notes

29/01/2016: Internal review.