Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
19/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Silverman

ORCID ID

Contact details

Leicester Children’s Asthma Centre
Department of Child Health
University of Leicester
PO Box 65
Leicester
LE2 7LX
United Kingdom
+44 (0)116 252 3262
ms70@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCH 16-15

Study information

Scientific title

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

01/05/1997

Overall trial end date

30/09/2000

Reason abandoned

Eligibility

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

Patient

Age group

Child

Gender

Both

Target number of participants

200

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/05/1997

Recruitment end date

30/09/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester Children’s Asthma Centre
Leicester
LE2 7LX
United Kingdom

Sponsor information

Organisation

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
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11809988

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