Skip to content

The Rotterdam Asthma Trial

Towards better asthma care for children: protocolled practice nurse-led care for children 6-12 years in primary care. A randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20109
Enrollment
180
Registered
2017-11-21
Start date
2018-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma in children

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')

Sponsors

Erasmus Medical Center Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The main study parameter is the overall asthma control in 18 months measured by the Childhood Asthma Control Test (C-ACT)

Secondary

MeasureTime frame
1. C-ACT outcomes during follow-up at 3, 6, 12 and 18 months. 2. Frequency and severity of exacerbations 3. Cost-effectiveness 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

Contacts

Public ContactS Bousema
s.bousema@erasmusmc.nl010-07032119

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)