Quality of Life in Asthmatic Children at School Age

Asthma Clinical Trial

Official title:

Quality of Life in Asthmatic Children at School Age : Influence of Therapeutic Education

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01475916
• Other study ID #: CHU-0105
• Status: Not yet recruiting
• Phase: N/A
• First received: September 23, 2011
• Last updated: November 17, 2011
• Start date: December 2011
• Est. completion date: October 2012

Study information

• Verified date: November 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Interventional

Clinical Trial 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.

Description:

Longitudinal prospective study

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 10 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Educational program: consultation with paediatric pulmonologist
Longitudinal prospective study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUQUEI questionnaire (Asthma Caregiver's Quality of Life)		3 or 4 months after the diagnosis of asthma	Yes
Secondary	Clinical control of asthma measured by the Asthma Control Test		3 or 4 months after the diagnosis of asthma	Yes
Secondary	Frequence and severity of the exacerbations		3 or 4 months after the diagnosis of asthma	Yes
Secondary	assessment of pulmonary function by spirometry		3 or 4 months after the diagnosis of asthma	Yes