Quality of Life in Asthmatic Children at School Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01475916
Recruitment Status : Unknown
Verified November 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

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 or disease Intervention/treatment Phase
Asthma Behavioral: Educational program: consultation with paediatric pulmonologist Not Applicable

Detailed Description:
Longitudinal prospective study

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Quality of Life in Asthmatic Children at School Age : Influence of Therapeutic Education
Study Start Date : December 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Intervention Details:
    Behavioral: Educational program: consultation with paediatric pulmonologist
    Longitudinal prospective study

Primary Outcome Measures :
  1. AUQUEI questionnaire (Asthma Caregiver's Quality of Life) [ Time Frame: 3 or 4 months after the diagnosis of asthma ]

Secondary Outcome Measures :
  1. Clinical control of asthma measured by the Asthma Control Test [ Time Frame: 3 or 4 months after the diagnosis of asthma ]
  2. Frequence and severity of the exacerbations [ Time Frame: 3 or 4 months after the diagnosis of asthma ]
  3. assessment of pulmonary function by spirometry [ Time Frame: 3 or 4 months after the diagnosis of asthma ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01475916

Contact: Patrick LACARIN 04 73 75 11 95

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

Responsible Party: University Hospital, Clermont-Ferrand Identifier: NCT01475916     History of Changes
Other Study ID Numbers: CHU-0105
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

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