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)
ID
Source
Health condition
Asthma in children
Sponsors and support
Intervention
Outcome measures
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
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
Background 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).
Study 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
baseline, t=3, t=6, t=12 and t=18 months
Intervention
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')
Erasmus MC, dept. General Practice, room 1923
Rotterdam
The Netherlands
010-07032119
s.bousema@erasmusmc.nl
Erasmus MC, dept. General Practice, room 1923
Rotterdam
The Netherlands
010-07032119
s.bousema@erasmusmc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6677 |
| NTR-old | NTR6847 |
| CCMO | NL63513.078.17 |
| OMON | NL-OMON55532 |