The effects of a nurse run clinic on the quality of life of children with atopic eczema and the impact of the disease on their families

ISRCTN	ISRCTN84190054
DOI	https://doi.org/10.1186/ISRCTN84190054
Protocol serial number	RRCC11R Poyner
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 04/02/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Chinn
Scientific

Centre for Primary and Community Care
University of Sunderland
Benedict Building
St George's Way
Sunderland
SR2 7BW
United Kingdom

Phone	+44 (0)191 515 3840

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Skin and connective tissue diseases
Intervention	1. Primary care nurse-led clinic 2. Standard care
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	08/01/2000

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	16 Years
Sex	All
Target sample size at registration	235
Key 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.
Key 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).
Date of first enrolment	04/01/1999
Date of final enrolment	08/01/2000

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Centre for Primary and Community Care

Sunderland
SR2 7BW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2002		Yes	No