Effectiveness of the Pelican Instrument in Medical Care

Asthma Clinical Trial

— PELICANII  

Official title:

Effectiveness of the Paediatric Electronic Quality of Life Instrument for Childhood Asthma in the Netherlands (Pelican) in Medical Care.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109745
• Other study ID #: NL29895.091.09
• Secondary ID: 3.4.07.0430802-7
• Status: Completed
• Phase: N/A
• First received: April 22, 2010
• Last updated: March 17, 2014
• Start date: August 2011
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The objective of this project is to establish the effectiveness of implementation of a self-administered electronic asthma-specific quality of life instrument for childhood asthma in primary care and specialist care.

Description:

Health related quality of life (HRQL) is important to the asthmatic child and if HRQL aspects are taken into account in daily care this could result in improved treatment satisfaction, compliance, asthma control and, ultimately, improved HRQL. The Pelican instrument we have developed has the essential features to be useful in daily care. In this study, the effectiveness of implementing the Pelican instrument in medical care is assessed. An intervention study with 9 months follow-up in primary and secondary care will be carried out.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• age 6 to 12 years

• physician-diagnosed asthma

• use of bronchodilators and / or inhaled corticosteroids for at least six weeks during the previous year

• child is treated for its asthma by the recruiting physician

• signed informed consent by parent (or caretaker)

• child agrees to participate in the study

Exclusion Criteria:

• comorbid condition that significantly influences HRQL

• child does not master the Dutch language sufficiently

• not being able to attend a regular school class

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• PELICAN Primary Care
The intervention is the integration of the output of the Pelican instrument in daily care to guide disease management for children with asthma treated in primary care. The general practitioner can integrate the information of the Pelican instrument in their consultation and disease management decisions. The general practitioner will be trained and supported to negotiate the child's, and physicians' agendas based on the outcome of the instrument, and discuss possible interventions. All participating children of a GP will be allocated to the same treatment group (i.e., hierarchical or nested design).
• PELICAN Secondary Care
The intervention is the integration of the output of the Pelican instrument in daily care to guide disease management for children with asthma treated in secondary care. The nurse can integrate the information of the Pelican instrument in their consultation and disease management decisions. The paediatricians will be trained and supported to negotiate the child's, and nurses' agendas based on the outcome of the instrument, and discuss possible interventions.

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Ziekenhuis	's Hertogenbosch
Netherlands	Amphia Ziekenhuis	Breda	Brabant
Netherlands	Reinier de Graaf Groep	Delft	Zuid-Holland
Netherlands	Catharina Ziekenhuis	Eindhoven	Brabant
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen
Netherlands	Viecuri Medical Centre	Venlo

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

van den Bemt L, Kooijman S, Linssen V, Lucassen P, Muris J, Slabbers G, Schermer T. How does asthma influence the daily life of children? Results of focus group interviews. Health Qual Life Outcomes. 2010 Jan 14;8:5. doi: 10.1186/1477-7525-8-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life	Asthma specific health related quality of life measured with the Pediatric asthma quality of life questionnaire PAQLQ(S)	9 months	No
Secondary	asthma control	asthma control will be measured with the Asthma Control Questionnaire (ACQ) and the Childhood Asthma Control Test (C-ACT)	9 months	No
Secondary	Symptoms and medication	asthmatic symptoms (e.g., wheezing, dyspnea) and medication use (e.g., use of inhaled corticosteroids, and short-acting bronchodilators) are assessed with a diary	9 months	No
Secondary	Lung function	Lung function indices (FEV1 and FVC before and 15 minutes after inhalation of 400 µg salbutamol) are measured by a certified lung function technician specifically trained to coach children using a spirometer with child-incentive. Spirometry tests will be performed according to ERS/ATS spirometry standards and recommendations regarding testing in children. Spirometry is performed at least 8 hrs after the last inhalation of a short-acting bronchodilator, and 12 hrs after a long-acting bronchodilator.	9 months	No
Secondary	Cost-effectiveness	A cost-effectiveness analysis (CEA) from a societal perspective will be performed and reported according to national and international guidelines. In the CEA an effect is defined as a relevant change in HRQL (i.e., ?PAQLQ =0.5 point) in the denominator and the total of all relevant costs in the nominator. C/E ratios with and without inclusion of the indirect cost will be reported. A sensitivity analysis will be performed in order to estimate the susceptibility of C/E ratio's to variation in prior assumptions and choices, including 'worst case - best case' scenarios.	9 months	No
Secondary	caregiver quality of life	The quality of life of the parents of the participating children is assessed with the Paediatric asthma caregiver quality of life (PACQoL) instrument.	9 months	No
Secondary	process-outcomes	The implementation of the Pelican instrument in daily care is an complex intervention. A detailed process evaluation is crucial to evaluate how the intervention works: what are the active ingredients and how are they exerting their effect?	9 months	No

External Links

•   Website of the project for participants (in Dutch)
•   Website Radboud University Nijmegen Medical Centre (in Dutch)