Effectiveness of the Pelican Instrument in Medical Care (PELICANII)

March 17, 2014 updated by: T. Schermer, Radboud University Medical Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • 's Hertogenbosch, Netherlands, 5223 GZ
        • Jeroen Bosch ziekenhuis
      • Nijmegen, Netherlands, 6500 HB
        • Radboud University Nijmegen Medical Centre
      • Venlo, Netherlands, 5912 BL
        • VieCuri Medical Centre
    • Brabant
      • Breda, Brabant, Netherlands, 4819 EV
        • Amphia Ziekenhuis
      • Eindhoven, Brabant, Netherlands, 5623 EJ
        • Catharina Ziekenhuis
    • Zuid-Holland
      • Delft, Zuid-Holland, Netherlands, 2625 AD
        • Reinier de Graaf Groep

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
9 months
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
9 months
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.
9 months
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.
9 months
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.
9 months
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?
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisette van den Bemt, PhD, Radboud University Medical Center
  • Study Director: Tjard RJ Schermer, PhD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL29895.091.09
  • 3.4.07.043 (Other Grant/Funding Number: Dutch Asthma Foundation)
  • 0802-74 (Other Grant/Funding Number: NutsOhra Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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