Effectiveness of the Pelican Instrument in Medical Care (PELICANII)

Radboud University Medical Center

Status: Completed

Conditions: Asthma

Treatments: Other: PELICAN Primary Care; Other: PELICAN Secondary Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01109745

3.4.07.043 (Other Grant/Funding Number)

NL29895.091.09

0802-74 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

usual primary care

No Intervention group

Description:

Number of participating children: 85

PELICAN Primary care

Experimental group

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

Treatment:

Other: PELICAN Primary Care

usual secondary care

No Intervention group

Description:

number of participating children: 50

PELICAN Secondary Care

Experimental group

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

Treatment:

Other: PELICAN Secondary Care