- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01475916
Quality of Life in Asthmatic Children at School Age
Quality of Life in Asthmatic Children at School Age : Influence of Therapeutic Education
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
AUQUEI questionnaire (Asthma Caregiver's Quality of Life)
Tijdsspanne: 3 or 4 months after the diagnosis of asthma
|
3 or 4 months after the diagnosis of asthma
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Clinical control of asthma measured by the Asthma Control Test
Tijdsspanne: 3 or 4 months after the diagnosis of asthma
|
3 or 4 months after the diagnosis of asthma
|
Frequence and severity of the exacerbations
Tijdsspanne: 3 or 4 months after the diagnosis of asthma
|
3 or 4 months after the diagnosis of asthma
|
assessment of pulmonary function by spirometry
Tijdsspanne: 3 or 4 months after the diagnosis of asthma
|
3 or 4 months after the diagnosis of asthma
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: André LABBE, Md, PhD, University Hospital, Clermont-Ferrand
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- CHU-0105
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .