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 |
| Secondary identifying numbers | RRCC11R Poyner |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| 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 | 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 study start date | 04/01/1999 |
| Completion date | 08/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 235 (added 21/01/10; see publication) |
| 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
- England
- United Kingdom
Study participating centre
Centre for Primary and Community Care
Sunderland
SR2 7BW
United Kingdom
SR2 7BW
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
