Condition category
Skin and Connective Tissue Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
04/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Chinn

ORCID ID

Contact details

Centre for Primary and Community Care
University of Sunderland
Benedict Building
St George's Way
Sunderland
SR2 7BW
United Kingdom
+44 (0)191 515 3840

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes