Trial of self-management for young children with asthma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15538429

Enrollment

200

Registered

2004-01-23

Start date

1997-05-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory tract diseases: Asthma Respiratory Asthma

Interventions

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 ses

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Does not match inclusion criteria

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026