Contact information
Type
Scientific
Primary contact
Prof Michael Silverman
ORCID ID
Contact details
Leicester Childrens 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 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
01/05/1997
Overall trial end date
30/09/2000
Reason abandoned (if study stopped)
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 Childrens 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
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
Basic results (scientific)
Publication list
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11809988
Publication citations
-
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.