Effectiveness of the Pelican Instrument in Medical Care

NCT01109745 | Completed

• 3 other identifiers: NL29895.091.093.4.07.0430802-74
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Asthma

Keywords

Asthma; health-related quality of life; patient-centred care

Outcome Measures

Primary Outcomes (1)

• quality of life

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

  9 months

Secondary Outcomes (6)

• asthma control

  9 months

• Symptoms and medication

  9 months

• Lung function

  9 months

• Cost-effectiveness

  9 months

• caregiver quality of life

  9 months

Study Arms (4)

usual primary care

NO INTERVENTION

Number of participating children: 85

PELICAN Primary care

EXPERIMENTAL

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

usual secondary care

NO INTERVENTION

number of participating children: 50

PELICAN Secondary Care

EXPERIMENTAL

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

Interventions

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 Primary care

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.

PELICAN Secondary Care

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (6)

Amphia Ziekenhuis

Breda, North Brabant, 4819 EV, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Reinier de Graaf Groep

Delft, South Holland, 2625 AD, Netherlands

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5223 GZ, Netherlands

Location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Viecuri Medical Centre

Venlo, 5912 BL, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 20074334 BACKGROUND

• 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.

  PMID: 27128738 DERIVED

• 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.

  PMID: 22935133 DERIVED

Related Links

• Website Radboud University Nijmegen Medical Centre (in Dutch)
• Website of the project for participants (in Dutch)

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Lisette van den Bemt, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Tjard RJ Schermer, PhD

  Radboud University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 23, 2010
• Study Start: August 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

NL (6)