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Completed

NCT Number: NCT01109745

Effectiveness of the Pelican Instrument 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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amphia Ziekenhuis, Breda, North Brabant, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PELICAN Primary Care

Other

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 Care

Other

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 outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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?

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Acronym: PELICANII

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Apr 23, 2010
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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