|- 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|- ISRCTN||ISRCTN no longer applicable|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-mei-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 Childhood Asthma Control Test (C-ACT)|
|- Secondary outcome||1. C-ACT outcomes during follow-up at 3, 6, 12 and 18 months. |
2. Frequency and severity of exacerbations
4. Quality of life assessed by the Standardised Paediatric Asthma Quality of Life Questionnaire (PAQLQ(S))
5. Patient/parent/nurse/GP satisfaction with delivered care
6. 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, Rotterdam|
(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 Childhood Asthma Control Test (C-ACT) (compared to usual care).
Secondary objectives include C-ACT 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, and forced expiratory volume in 1 second (FEV1) and forced expiratory flow 75 (FEF 75).
|- Main changes (audit trail)|
|- RECORD||21-nov-2017 - 15-feb-2018|