|- candidate number||28248|
|- NTR Number||NTR6847|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-nov-2017|
|- Secondary IDs||NL63513.078.17 METC|
|- Public Title||The Rotterdam Asthma Trial|
|- Scientific Title||Towards better asthma care for children: protocolled practice
nurse-led care for children 6-12 years in primary care. A randomized controlled trial.
|- hypothesis||To determine the effect of protocolled practice nurse-led asthma care for children aged 6 to 12 years old in primary care on asthma control (compared to usual care)|
|- Healt Condition(s) or Problem(s) studied||Asthma, Children|
|- Inclusion criteria||-Patients who were prescribed one or more times an ICS in the last year. |
-Patients who were prescribed 2 or more times a prescription of salbutamol or terbutaline in the last year.
-Children with only one prescription of salbutamol or terbutaline in the last year and a registered ICPC-code for asthma (R96).
|- Exclusion criteria||-Children receiving asthma treatment from secondary care.|
-Children who are not able to perform lung function tests.
-Children with other major chronic diseases (children with atopic conditions such as eczema or allergies are not excluded, since this is a prevalent co-morbidity co-morbidity)
-Children whose parents are unable to understand verbal Dutch instructions or written Dutch questionnaires.
-Children who did not use inhaled asthma medication for at least 6 weeks in the previous year.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2018|
|- planned closingdate||1-nov-2020|
|- Target number of participants||180|
|- Interventions||protocolled nurse led care for children aged 6-12 years. The content of the protocol is based on two Dutch Guidelines for children with Asthma ('NHG guideline' and 'Zorgstandaard')|
|- Primary outcome||The main study parameter is the overall asthma control in 18 months measured by the Asthma Control Questionnaire (ACQ).|
|- Secondary outcome||1. ACQ outcomes during follow-up at 3, 6, 12 and 18 months. |
2. Baseline characteristics
3. Prognostic factors for high symptom scores in children with asthma.
4. Frequency and severity of exacerbations
6. Quality of life assessed by the Standardised Paediatric Asthma Quality of Life Questionnaire (PAQLQ(S))
7. Patient/parent/nurse/GP satisfaction with delivered care
8. Spirometry: FEV1, Forced Expiratory Flow 75 (FEF 75) and reversibility
|- Timepoints||baseline, t=3, t=6, t=12 and t=18 months|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| S Bousema|
|- CONTACT for SCIENTIFIC QUERIES|| S Bousema|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief summary||Objective: To determine the effect of protocolled practice nurse-led asthma care for children aged 6 to 12 years old in primary care on asthma control (compared to usual care).
Study design: This study will be a cluster-randomized open label trial with a follow-up of 18 months, in which the practice nurses will be the units of randomization and children with asthma will be the units of analysis.
Study population: Children with asthma in primary care aged 6-12 years.
Intervention: The practice nurses of the GP-practices will be randomized to protocolled practice nurse-led care, or usual care by the GP.
Main study parameters/endpoints:
Primary objective: to determine the overall treatment effect (0 to 18 months) of protocolled practice nurse-led asthma care for children aged 6 to 12 years old in primary care on asthma control, measured by the Asthma Control Questionnaire (ACQ) (compared to usual care).
Secondary objectives include ACQ scores at t=3, t=6 and t=12 months. Frequency and severity of exacerbations, cost-effectiveness, quality of life, patient/caregiver/nurse/GP satisfaction with delivered care, forced expiratory volume in 1 second (FEV1) and forced expiratory flow 75 (FEF 75), prognostic factors for high symptoms scores in children with asthma
|- Main changes (audit trail)|
|- RECORD||21-nov-2017 - 12-dec-2017|