Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RRCC11R Poyner
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the effect of a primary care nurse-led clinic (the intervention) on the quality of life (QoL) of children aged up to 16 years with atopic eczema. Secondary objective: to assess the impact of the intervention on the QoL of the family of these children.
Null hypotheses to be tested:
1. There is no effect on change in quality of life at 4 weeks (or 12 weeks) from a short intervention by a trained nurse in children aged 6 months to 16 years who present with atopic eczema
2. There is no effect on change in the family impact at 4 weeks (or 12 weeks) from a short intervention by a trained nurse in children aged 6 months-16 years who present with atopic eczema
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Condition
Skin and connective tissue diseases
Intervention
1. Primary care nurse-led clinic
2. Standard care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Quality of life will be assessed using validated instruments:
1. Family Impact Questionnaire (FIQ).
2. Infant Eczema Life Quality Index questionnaire (IELQI) for children aged 6 months to 4 years.
3. Children's Dermatology Life Quality Index Questionnaire (CDLQI) for children aged 4-16.
4. Change in the Family Dermatitis Index (FDI), Infants Eczema Life Quality Index (IELQI) and Children's Dermatology Life Quality Index (CDLQI) recorded at baseline and at 4 weeks and 12 weeks post-intervention.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
04/01/1999
Overall trial end date
08/01/2000
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 6 months up to 16th birthday
2. Diagnosis of atopic eczema made using British Association of Dermatology guidelines
3. New cases and patients requesting repeat prescription for medication issued for a diagnosis of atopic eczema.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
235 (added 21/01/10; see publication)
Participant exclusion criteria
1. Poorly controlled asthma defined as patient receiving oral steroids or having a change in dose of medication in the 4 weeks prior to recruitment (children with stable asthma will be included).
2. Children from the same family of a child who has already participated in the trial (to eliminate the risk of contamination of intervention and control groups).
Recruitment start date
04/01/1999
Recruitment end date
08/01/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Primary and Community Care
Sunderland
SR2 7BW
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11952543
Publication citations
-
Results
Chinn DJ, Poyner T, Sibley G, Randomized controlled trial of a single dermatology nurse consultation in primary care on the quality of life of children with atopic eczema., Br. J. Dermatol., 2002, 146, 3, 432-439.