Comparison study of treatment given to children with asthma by a nurse practitioner, a general practitioner or a pediatrician. (Vergelijkende studie met betrekking tot de controle van kinderen met astma door de nurse practitioner, de huisarts of de kinderarts)

ISRCTN	ISRCTN95392638
DOI	https://doi.org/10.1186/ISRCTN95392638
Secondary identifying numbers	N/A

Submission date: 11/08/2011
Registration date: 26/08/2011
Last edited: 30/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Maarten Kuethe
Scientific

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

Study information

Study design	Randomized controlled trial
Primary study design	Observational
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	TRAM
Study objectives	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(s)	TWOR Medical Centre "Rijnmond" South, Rotterdam approved on 11 January 2008, ref: nl.17972.101.07
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Inhaled corticosteroid (beta-2-agonist), PD20 methacholine
Primary outcome measure	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 study start date	04/03/2005
Completion date	28/01/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	110
Key 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)
Key exclusion criteria	Serious, poorly controlled asthma requiring step intravenous (IV) treatment according to the action plan in the guideline
Date of first enrolment	04/03/2005
Date of final enrolment	28/01/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Department of Pediatrics

Breda
4800 RL
Netherlands

Sponsor information

Amphia Hospital (Netherlands)
Hospital/treatment centre

Langendijk 75
Breda
4819 EV
Netherlands

Website	http://www.amphia.nl/Pages/default.aspx
"ROR"	https://ror.org/01g21pa45

Funders

Funder type

Hospital/treatment centre

Amphia Hospital (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Comparison study of treatment given to children with asthma by a nurse practitioner, a general practitioner or a pediatrician. (Vergelijkende studie met betrekking tot de controle van kinderen met astma door de nurse practitioner, de huisarts of de kinderarts)