Effectiveness of the Pelican Instrument in Medical Care

Radboud University Medical Center120 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

120

Conditions

Asthma

Interventions

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (6)

Amphia Ziekenhuis

Breda, North Brabant, Netherlands

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Reinier de Graaf Groep

Delft, South Holland, Netherlands

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Outcomes

Primary Outcomes

quality of life

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

Time frame: 9 months

Secondary Outcomes

asthma control

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

Time frame: 9 months

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

Time frame: 9 months

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.

Time frame: 9 months

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.

Time frame: 9 months

Data from ClinicalTrials.gov

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