Effectiveness of the Pelican Instrument in Medical Care (PELICANII)
|ClinicalTrials.gov Identifier: NCT01109745|
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : March 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Other: PELICAN Primary Care Other: PELICAN Secondary Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Effectiveness of the Paediatric Electronic Quality of Life Instrument for Childhood Asthma in the Netherlands (Pelican) in Medical Care.|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||March 2014|
No Intervention: usual primary care
Number of participating children: 85
Experimental: 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
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).
No Intervention: usual secondary care
number of participating children: 50
Experimental: 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
Other: 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.
- quality of life [ Time Frame: 9 months ]Asthma specific health related quality of life measured with the Pediatric asthma quality of life questionnaire PAQLQ(S)
- asthma control [ Time Frame: 9 months ]asthma control will be measured with the Asthma Control Questionnaire (ACQ) and the Childhood Asthma Control Test (C-ACT)
- Symptoms and medication [ Time Frame: 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
- Lung function [ Time Frame: 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 [ Time Frame: 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.
- caregiver quality of life [ Time Frame: 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.
- process-outcomes [ Time Frame: 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?
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109745
|Breda, Brabant, Netherlands, 4819 EV|
|Eindhoven, Brabant, Netherlands, 5623 EJ|
|Reinier de Graaf Groep|
|Delft, Zuid-Holland, Netherlands, 2625 AD|
|Jeroen Bosch Ziekenhuis|
|'s Hertogenbosch, Netherlands, 5223 GZ|
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Netherlands, 6500 HB|
|Viecuri Medical Centre|
|Venlo, Netherlands, 5912 BL|
|Principal Investigator:||Lisette van den Bemt, PhD||Radboud University|
|Study Director:||Tjard RJ Schermer, PhD||Radboud University|