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van CCT (UK)

van CCT (UK)

The Rotterdam Asthma Trial

- candidate number28248
- NTR NumberNTR6847
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-nov-2017
- Secondary IDsNL63513.078.17  METC
- Public TitleThe Rotterdam Asthma Trial
- Scientific TitleTowards better asthma care for children: protocolled practice nurse-led care for children 6-12 years in primary care. A randomized controlled trial.
- hypothesisTo 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) studiedAsthma, 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 receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2018
- planned closingdate1-nov-2020
- Target number of participants180
- Interventionsprotocolled 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 outcomeThe main study parameter is the overall asthma control in 18 months measured by the Asthma Control Questionnaire (ACQ).
- Secondary outcome1. 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
5. Cost-effectiveness
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
- Timepointsbaseline, t=3, t=6, t=12 and t=18 months
- Trial web site
- statusplanned
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryObjective: 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)
- RECORD21-nov-2017 - 12-dec-2017

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