Trial of self-management for young children with asthma
| ISRCTN | ISRCTN15538429 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15538429 |
| Secondary identifying numbers | MCH 16-15 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 19/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Michael Silverman
Scientific
Scientific
Leicester Childrens Asthma Centre
Department of Child Health
University of Leicester
PO Box 65
Leicester
LE2 7LX
United Kingdom
| Phone | +44 (0)116 252 3262 |
|---|---|
| ms70@le.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | |
| Study objectives | This study was designed to test the hypothesis that the introduction of an educational package and self-management guide to the parents of pre-school children who have recently attended hospital for troublesome asthma or wheeze will reduce morbidity. While the primary objective was to assess the effect of the intervention on the number of hospital readmissions and GP consultations, also investigated were the effects on the child's and family's quality of life and their knowledge of asthma. A cost-evaluation of introducing the intervention was performed. |
| Ethics approval(s) | Approved by Leicestershire Research Ethics Committee (Added 19/11/09) |
| Health condition(s) or problem(s) studied | Respiratory tract diseases: Asthma |
| Intervention | The intervention consisted of three elements: 1. A general education booklet about asthma in pre-school children 2. A written, guided self-management plan 3. Two 20 minute, structured, educational sessions between a specialist respiratory nurse and the parent(s) and child. Children randomised to the intervention group and recruited as in-patients received the first education session on the ward on the day of discharge and returned to a special clinic one month later for the second session. Children recruited from A&E or the Children's (Emergency) Assessment Unit (LRI) received their initial education session in the clinic within two weeks of attendance at A&E/CAU and returned one month later for their follow-up visit. The first educational session focused in sequence on the topics covered in the booklet and included personalization of the self-management plan while the second session aimed to be parent-led, discussing issues raised by the parents with a review of parents' techniques in administering medicines to their child. Children randomised to the control group received usual care (a range of medical and nursing approaches presently used with parents, according to the skills of the health professionals). |
| Intervention type | Other |
| Primary outcome measure | All subjects were assessed at three, six and 12 months following recruitment. The primary outcomes were GP consultation rates, hospital re-admissions and attendances at A&E/CAU. These were collected from the child's GP records and from hospital notes and records. Several secondary outcomes were measured. The child's asthma symptoms and consequent level of disability as perceived by the parents was assessed using Usherwood's (1990) Index of Perceived Symptoms in Asthmatic Children (IPSAC). The parent's or caregiver's quality of life was assessed using Juniper's Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ). Symptom diaries were used to measure morbidity over a period of four weeks prior to each follow-up visit. Three further measures were developed for use in this study to assess the parent's or caregiver's knowledge of asthma, their perceived confidence in caring for their child and the social and economic impact on the family of caring for a child with wheeze. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/1997 |
| Completion date | 30/09/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 18 Months |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | Children eligible for inclusion in the study were aged 18 months to five years inclusive at the time of admission to a children's ward as an in-patient or attendance at either an Accident and Emergency Department or the Children's (Emergency) Assessment Unit (CAU at LRI) with a primary diagnosis of acute severe asthma or wheezing. The study was not confined to children admitted for the first time for wheeze/asthma. Children could only be recruited to the study once during the trial period. The study was conducted in two centres; the Children's Hospital, Leicester Royal Infirmary (LRI) and Booth Hall Children's Hospital, Manchester (BH) (secondary care centres). 200 children were recruited to the study of which 101 were assigned to the control group and 99 to the intervention group. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/05/1997 |
| Date of final enrolment | 30/09/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leicester Childrens Asthma Centre
Leicester
LE2 7LX
United Kingdom
LE2 7LX
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS Mother and Child Health National Research and Development Programme (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 | 01/01/2002 | Yes | No |
