| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN15538429 |
| Date ISRCTN assigned | 23/01/2004 |
| Local reference number(s) | MCH 16-15 |
| Public title | Trial of self-management for young children with asthma. |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Respiratory tract diseases: Asthma |
| Study hypothesis | 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/05/1997 |
| Anticipated end date | 30/09/2000 |
| Status of trial | Completed |
| Target number of participants | 200 |
| Interventions | The intervention consisted of three elements:
i. A general education booklet about asthma in pre-school children
ii. A written, guided self-management plan
iii. Two 20 minute, structured, educational sessions between a specialist respiratory nurse and the parent(s) and child.
Children randomized 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 randomized 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). |
| Primary outcome measure(s) | 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 measure(s) | Not provided at time of registration |
| Sources of funding | NHS Mother and Child Health National Research and Development Programme |
| Sponsor name | Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK) |
| Sponsor details | The Department of Health
Richmond House
79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Prof Michael Silverman |
| Contact details | Leicester Children’s Asthma Centre
Department of Child Health
University of Leicester
PO Box 65
Leicester
United Kingdom
LE2 7LX |
| Contact telephone | +44 (0)116 252 3262 |
| Contact fax | +44 (0)116 252 3282 |
| Contact email | ms70@le.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN15538429 |
| Date last extracted from ISRCTN register | 17/04/2008 |
