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AsthmaPELICANIINCT01109745

Effectiveness of the Pelican Instrument in Medical Care

A study testing PELICAN Primary Care and PELICAN Secondary Care in people with Asthma, run by Radboud University Medical Center at 6 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Asthma
What is being tested?
PELICAN Primary Care and PELICAN Secondary Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
6 sitesNetherlands
Study dates
Aug 2011to Mar 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • comorbid condition that significantly influences HRQL
  • child does not master the Dutch language sufficiently
  • not being able to attend a regular school class

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Netherlands6 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ

  • Amphia Ziekenhuis

    Breda, North Brabant, 4819 EV

  • Reinier de Graaf Groep

    Delft, South Holland, 2625 AD

  • Catharina Ziekenhuis

    Eindhoven, North Brabant, 5623 EJ

  • Radboud University Nijmegen Medical Centre

    Nijmegen, 6500 HB

  • Viecuri Medical Centre

    Venlo, 5912 BL

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Conditions
Asthma
Being tested
PELICAN Primary Care, PELICAN Secondary Care
Keywords
Asthma, health-related quality of life, patient-centred care
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PELICAN Primary CareOther

    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).

  • PELICAN Secondary CareOther

    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.

Study groups in NCT01109745
Study groupRoleWhat they receive
usual primary careNo interventionNumber of participating children: 85
PELICAN Primary careExperimentalIntervention 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
Receives: Other: PELICAN Primary Care
usual secondary careNo interventionnumber of participating children: 50
PELICAN Secondary CareExperimentalIntervention 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
Receives: Other: PELICAN Secondary Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. quality of life

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

    Measured: 9 months

Secondary outcomes (6)

  1. asthma control

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

    Measured: 9 months

  2. 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

    Measured: 9 months

  3. 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.

    Measured: 9 months

  4. 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.

    Measured: 9 months

  5. 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.

    Measured: 9 months

  6. 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?

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2010 (estimated)
  2. Study startAug 2011
  3. Primary completionDec 2013
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01109745
Sponsor's protocol ID
NL29895.091.09
Other IDs
3.4.07.043, 0802-74
Acronym
PELICANII
Status last verified
Mar 2014
First submitted
22 Apr 2010
Last updated
18 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20074334

  • 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.

    PubMed 27128738

  • 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.

    PubMed 22935133

Questions about this trial

What is this clinical trial studying?

A study testing PELICAN Primary Care and PELICAN Secondary Care in people with Asthma, run by Radboud University Medical Center at 6 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

quality of life (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01109745, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.

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