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
Bron
Aandoening
Asthma in children
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main study parameter is the overall asthma control in 18 months measured by the Childhood Asthma Control Test (C-ACT)
Achtergrond van het onderzoek
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).
Doel van het onderzoek
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)
Onderzoeksopzet
baseline, t=3, t=6, t=12 and t=18 months
Onderzoeksproduct en/of interventie
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')
Publiek
Erasmus MC, dept. General Practice, room 1923
Rotterdam
The Netherlands
010-07032119
s.bousema@erasmusmc.nl
Wetenschappelijk
Erasmus MC, dept. General Practice, room 1923
Rotterdam
The Netherlands
010-07032119
s.bousema@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6677 |
| NTR-old | NTR6847 |
| CCMO | NL63513.078.17 |
| OMON | NL-OMON55532 |