Effectiveness of the Pelican Instrument in Medical Care (PELICANII)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
T. Schermer, Radboud University
ClinicalTrials.gov Identifier:
NCT01109745
First received: April 22, 2010
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Asthma
Other: PELICAN Primary Care
Other: PELICAN Secondary Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
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.

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • quality of life [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Asthma specific health related quality of life measured with the Pediatric asthma quality of life questionnaire PAQLQ(S)


Secondary Outcome Measures:
  • asthma control [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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?


Enrollment: 120
Study Start Date: August 2011
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109745

Locations
Netherlands
Amphia Ziekenhuis
Breda, Brabant, Netherlands, 4819 EV
Catharina Ziekenhuis
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
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Lisette van den Bemt, PhD Radboud University
Study Director: Tjard RJ Schermer, PhD Radboud University
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: T. Schermer, PhD, Radboud University
ClinicalTrials.gov Identifier: NCT01109745     History of Changes
Other Study ID Numbers: NL29895.091.09, 3.4.07.043, 0802-74
Study First Received: April 22, 2010
Last Updated: March 17, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Asthma
health-related quality of life
patient-centred care

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014