Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Michael Silverman


Contact details

Leicester Children’s Asthma Centre
Department of Child Health
University of Leicester
PO Box 65
United Kingdom
+44 (0)116 252 3262

Additional identifiers

EudraCT number number

Protocol/serial number

MCH 16-15

Study information

Scientific title


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.

Ethics approval

Approved by Leicestershire Research Ethics Committee (Added 19/11/09)

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet


Respiratory tract diseases: Asthma


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



Not Specified

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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.

Participant type


Age group




Target number of participants


Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Leicester Children’s Asthma Centre
United Kingdom

Sponsor information


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
United Kingdom

Sponsor type




Funder type


Funder name

NHS Mother and Child Health National Research and Development Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2002 results in

Publication citations

  1. Results

    Stevens CA, Wesseldine LJ, Couriel JM, Dyer AJ, Osman LM, Silverman M, Parental education and guided self-management of asthma and wheezing in the pre-school child: a randomised controlled trial., Thorax, 2002, 57, 1, 39-44.

Additional files

Editorial Notes