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
Protocol serial number	N/A
Sponsor	Amphia Hospital (Netherlands)
Funder	Amphia Hospital (Netherlands)

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

Primary study design	Observational
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Inhaled corticosteroid (beta-2-agonist), PD20 methacholine
Primary outcome measure(s)	1. Airway hyper responsiveness 2. PD20 methacholine Measured at baseline, one year & two year
Key secondary outcome measure(s)	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
Completion date	28/01/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	16 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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)