Quality of Life in Asthmatic Children at School Age

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01475916
First received: September 23, 2011
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

Asthma is the most common chronic disease in childhood [1]. The advantage of an educational program in a global strategy of care has been established in asthma (decrease of nocturnal asthma, absence from work and school) [2, 3]. Therapeutic education of the patient permits the reduction of the rate of hospitalization, of the rate of emergencies visits and non-programmed visits. [3].

The WHO defines quality of life as an individual's perception of its place in existence, in the context of culture and value system in which he lives, in relation to its objectives, expectations, standards and concerns [4]. The basic point of this concept is the notion of perception, emphasizing the perspective of the person. It is a broad concept affected in a complex way by the subject's physical health, psychological state, level of independence, social relationships, and its relations with its environment. In the field of health, analyzing the quality of life includes objective aspects (living conditions, functional health) and subjective aspects (satisfaction, happiness, well-being) that allow to understand the situation of people in whole.

As defined by the WHO-Europe report published in 1996 [5], the therapeutic education aims to help patients acquire or maintain the competencies they need to best manage their lives with a chronic disease.

It is entirely part of the management of the patient. It includes organized activities designed to make patients aware and informed of their disease, of care organization and hospital procedures, and the behaviors related to health and disease. This is to help them and their families understand their illness and treatment, to work together and to gain autonomy from their disease in order to help maintain and improve their quality of life [6].

However, studies demonstrating the effectiveness of therapeutic patient education are still very few, especially in children. The need for prospective studies including the evaluation of the impact on quality of life was highlighted in a recent Cochrane meta-analysis [7]. It seems interesting for the authors to assess the improvement of the quality of life after educational sessions in children at school-age.


Condition Intervention
Asthma
Behavioral: Educational program: consultation with paediatric pulmonologist

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Quality of Life in Asthmatic Children at School Age : Influence of Therapeutic Education

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • AUQUEI questionnaire (Asthma Caregiver's Quality of Life) [ Time Frame: 3 or 4 months after the diagnosis of asthma ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical control of asthma measured by the Asthma Control Test [ Time Frame: 3 or 4 months after the diagnosis of asthma ] [ Designated as safety issue: Yes ]
  • Frequence and severity of the exacerbations [ Time Frame: 3 or 4 months after the diagnosis of asthma ] [ Designated as safety issue: Yes ]
  • assessment of pulmonary function by spirometry [ Time Frame: 3 or 4 months after the diagnosis of asthma ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Educational program: consultation with paediatric pulmonologist
    Longitudinal prospective study
Detailed Description:

Longitudinal prospective study

  Eligibility

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • School-aged (from 5 to 10 years old) asthmatic children consulting for the first time a paediatric pulmonologist

Exclusion Criteria:

  • Other non-atopic chronic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475916

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: André LABBE, Md, PhD University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01475916     History of Changes
Other Study ID Numbers: CHU-0105
Study First Received: September 23, 2011
Last Updated: November 17, 2011
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by University Hospital, Clermont-Ferrand:
Asthma
Educational program
Quality of life
School-aged children

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014