Effectiveness of the Pelican Instrument in Medical Care

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: PELICAN Primary Care; Other: PELICAN Secondary Care

• Registration Number: NCT01109745
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Study Start: 2011-08
• Primary Completion: 2013-12
• Status Verified: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-17
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PELICAN Primary care	PELICAN Primary Care	Intervention arm: the integration of the output of the Pelican instrument (i.e., individualised HRQL information) in daily care to guide disease management for children with asthma treated in primary care. Number of participants: 85 children
PELICAN Secondary Care	PELICAN Secondary Care	Intervention arm: the integration of the output of the Pelican instrument (i.e., individualised HRQL information) in daily care to guide disease management for children with asthma treated in primary care. Number of participants: 50 children

Primary Outcome Measures

Name	Time	Method
quality of life	9 months	Asthma specific health related quality of life measured with the Pediatric asthma quality of life questionnaire PAQLQ(S)

Secondary Outcome Measures

Name	Time	Method
Symptoms and medication	9 months	asthmatic symptoms (e.g., wheezing, dyspnea) and medication use (e.g., use of inhaled corticosteroids, and short-acting bronchodilators) are assessed with a diary
asthma control	9 months	asthma control will be measured with the Asthma Control Questionnaire (ACQ) and the Childhood Asthma Control Test (C-ACT)
caregiver quality of life	9 months	The quality of life of the parents of the participating children is assessed with the Paediatric asthma caregiver quality of life (PACQoL) instrument.
Lung function	9 months	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.
Cost-effectiveness	9 months	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.
process-outcomes	9 months	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?

Trial Locations

Locations (6)

Jeroen Bosch Ziekenhuis; 🇳🇱 's Hertogenbosch, Netherlands

Amphia Ziekenhuis; 🇳🇱 Breda, Brabant, Netherlands

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Brabant, Netherlands

Reinier de Graaf Groep; 🇳🇱 Delft, Zuid-Holland, Netherlands

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands

Viecuri Medical Centre; 🇳🇱 Venlo, Netherlands