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Effectiveness of the Pelican Instrument in Medical Care (PELICANII)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PELICAN Primary Care
PELICAN Secondary Care
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Asthma, health-related quality of life, patient-centred care

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amphia Ziekenhuis
  • Catharina Ziekenhuis
  • Reinier de Graaf Groep
  • Jeroen Bosch Ziekenhuis
  • Radboud University Nijmegen Medical Centre
  • Viecuri Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Arm Label

usual primary care

PELICAN Primary care

usual secondary care

PELICAN Secondary Care

Arm Description

Number of participating children: 85

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

number of participating children: 50

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

Outcomes

Primary Outcome Measures

quality of life
Asthma specific health related quality of life measured with the Pediatric asthma quality of life questionnaire PAQLQ(S)

Secondary Outcome Measures

asthma control
asthma control will be measured with the Asthma Control Questionnaire (ACQ) and the Childhood Asthma Control Test (C-ACT)
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
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.
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.
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.
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?

Full Information

First Posted
April 22, 2010
Last Updated
March 17, 2014
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01109745
Brief Title
Effectiveness of the Pelican Instrument in Medical Care
Acronym
PELICANII
Official Title
Effectiveness of the Paediatric Electronic Quality of Life Instrument for Childhood Asthma in the Netherlands (Pelican) in Medical Care.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, health-related quality of life, patient-centred care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
usual primary care
Arm Type
No Intervention
Arm Description
Number of participating children: 85
Arm Title
PELICAN Primary care
Arm Type
Experimental
Arm Description
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
Arm Title
usual secondary care
Arm Type
No Intervention
Arm Description
number of participating children: 50
Arm Title
PELICAN Secondary Care
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
PELICAN Primary Care
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
PELICAN Secondary Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
quality of life
Description
Asthma specific health related quality of life measured with the Pediatric asthma quality of life questionnaire PAQLQ(S)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
asthma control
Description
asthma control will be measured with the Asthma Control Questionnaire (ACQ) and the Childhood Asthma Control Test (C-ACT)
Time Frame
9 months
Title
Symptoms and medication
Description
asthmatic symptoms (e.g., wheezing, dyspnea) and medication use (e.g., use of inhaled corticosteroids, and short-acting bronchodilators) are assessed with a diary
Time Frame
9 months
Title
Lung function
Description
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.
Time Frame
9 months
Title
Cost-effectiveness
Description
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.
Time Frame
9 months
Title
caregiver quality of life
Description
The quality of life of the parents of the participating children is assessed with the Paediatric asthma caregiver quality of life (PACQoL) instrument.
Time Frame
9 months
Title
process-outcomes
Description
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?
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisette van den Bemt, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tjard RJ Schermer, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Amphia Ziekenhuis
City
Breda
State/Province
Brabant
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
State/Province
Brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Reinier de Graaf Groep
City
Delft
State/Province
Zuid-Holland
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Jeroen Bosch Ziekenhuis
City
's Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Viecuri Medical Centre
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
20074334
Citation
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.
Results Reference
background
PubMed Identifier
27128738
Citation
van Bragt S, van den Bemt L, Cretier R, van Weel C, Merkus P, Schermer T. PELICAN: Content evaluation of patient-centered care for children with asthma based on an online tool. Pediatr Pulmonol. 2016 Oct;51(10):993-1003. doi: 10.1002/ppul.23397. Epub 2016 Apr 29.
Results Reference
derived
PubMed Identifier
22935133
Citation
van Bragt S, van den Bemt L, Thoonen B, van Weel C, Merkus P, Schermer T. PELICAN: A quality of life instrument for childhood asthma: study protocol of two randomized controlled trials in primary and specialized care in the Netherlands. BMC Pediatr. 2012 Aug 30;12:137. doi: 10.1186/1471-2431-12-137.
Results Reference
derived
Links:
URL
http://www.umcn.nl
Description
Website Radboud University Nijmegen Medical Centre (in Dutch)
URL
http://pelikaan.ruhosting.nl
Description
Website of the project for participants (in Dutch)

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Effectiveness of the Pelican Instrument in Medical Care

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