Condition category
Respiratory
Date applied
11/08/2011
Date assigned
26/08/2011
Last edited
30/08/2011
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

Mr Maarten Kuethe

ORCID ID

Contact details

Department of Pediatrics
Amphia hospital
PO Box 90157
Breda
4800 RL
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison study to follow-up of treatment given to children with stable asthma by a nurse practitioner, a general practitioner or a pediatrician: a randomized controlled trial

Acronym

TRAM

Study hypothesis

TRAM (TRans mural Asthma Management). Treatment of children with stable asthma by a nurse practitioner is not inferior to treatment by a general practitioner or a pediatrician.

Ethics approval

TWOR Medical Centre "Rijnmond" South, Rotterdam approved on 11 January 2008, ref: nl.17972.101.07

Study design

Randomized controlled trial

Primary study design

Observational

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pediatric asthma

Intervention

Children were randomly assigned to one of the three follow up arm and at baseline, one year & two year a variety of outcome measures were collected.

1. Management by general practitioner
2. Management by paediatrician
3. Management by asthma nurse

Intervention type

Drug

Phase

Not Applicable

Drug names

Inhaled corticosteroid (beta-2-agonist), PD20 methacholine

Primary outcome measures

1. Airway hyper responsiveness
2. PD20 methacholine
Measured at baseline, one year & two year

Secondary outcome measures

1. Forced expiratory volume in one second (FEV1) before and after bronchus dilatation with beta-2-agonist
2. Exhaled nitric oxide (NO)
3. Asthma Control Questionaire
4. Health economics
5. Prescribed medication
6. Quality of Care assessment by completing the QUOTE-CNSLD instrument by parents
7. Completion of Likert scale by the children

Overall trial start date

04/03/2005

Overall trial end date

28/01/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children 6-16 years
2. Moderate asthma as defined by the guideline of the dutch pediatric pulmonologists or diagnosed as asthma by their general practioner (GP) and on prophylactic treatment with inhaled corticosteroid (ICS)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

110

Participant exclusion criteria

Serious, poorly controlled asthma requiring step intravenous (IV) treatment according to the action plan in the guideline

Recruitment start date

04/03/2005

Recruitment end date

28/01/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Pediatrics
Breda
4800 RL
Netherlands

Sponsor information

Organisation

Amphia Hospital (Netherlands)

Sponsor details

Langendijk 75
Breda
4819 EV
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amphia.nl/Pages/default.aspx

Funders

Funder type

Hospital/treatment centre

Funder name

Amphia Hospital (Netherlands)

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