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
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