Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
16/03/2016
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

Ms Philippa Madge

ORCID ID

Contact details

Department of Child Health
University of Glasgow
Yorkhill NHS Trust
Glasgow
G3 8SJ
United Kingdom
+44 (0)141 201 0236
philippa.madge@ggc.scot.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Enhancing self-regulation skills in teenagers with severe asthma through a nurse-led intervention: a randomised controlled trial

Acronym

Study hypothesis

Asthma is prevalent amongst teenagers and often causes significant morbidity. In a small number with severe asthma, who often have many psycho-social risk factors, there is high health care utilisation reflected particularly in frequent hospital admissions. Such teenagers present a challenge because they often do not respond to conventional medical approaches. A randomised controlled trial of the impact of a small group educational intervention, led by a nurse-educator, designed to promote asthma self-regulatory skills in teenagers will be undertaken.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Asthma

Intervention

The group work will be based on a specially developed asthma workbook and will focus on the key skills of asthma prevention and attack management, and social skill training in areas important to asthma management in teenagers.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The success of the programme will be judged by its ability to reduce subsequent health care utilisation. If successful, such an approach could have considerable impact on a high risk group and would be easily adaptable for general introduction.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1999

Overall trial end date

01/09/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Teenagers with severe asthma, defined as at least one acute hospital admission within the last year.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/10/1999

Recruitment end date

01/09/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Child Health
Glasgow
G3 8SJ
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 Asthma 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

Publication citations

Additional files

Editorial Notes

16/03/2016: No publications found, verifying study status with principal investigator.