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AsthmaNCT01475916

Quality of Life in Asthmatic Children at School Age

A study testing Educational program: consultation with paediatric pulmonologist in people with Asthma, run by University Hospital, Clermont-Ferrand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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]. Read more about this study

Who is it for?
Ages 5 to 10 years
Conditions the study is for
Asthma
What is being tested?
Educational program: consultation with paediatric pulmonologist
How many people
40 participants
Where
No sites listed yet
Study dates
Dec 2011to Oct 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • Other non-atopic chronic disease

Trial locations and contacts

No sites are listed yet.

About this study

Official title: 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.

Read more

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.

Read the detailed description

Longitudinal prospective study

Conditions
Asthma
Being tested
Educational program: consultation with paediatric pulmonologist
Keywords
Asthma, Educational program, Quality of life, School-aged children
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational program: consultation with paediatric pulmonologistBehavioural

    Longitudinal prospective study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUQUEI questionnaire (Asthma Caregiver's Quality of Life)

    Measured: 3 or 4 months after the diagnosis of asthma

Secondary outcomes (3)
  1. Clinical control of asthma measured by the Asthma Control Test

    Measured: 3 or 4 months after the diagnosis of asthma

  2. Frequence and severity of the exacerbations

    Measured: 3 or 4 months after the diagnosis of asthma

  3. assessment of pulmonary function by spirometry

    Measured: 3 or 4 months after the diagnosis of asthma

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionApr 2012 (estimated)
  4. Study completionOct 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01475916
Sponsor's protocol ID
CHU-0105
Status last verified
Nov 2011
First submitted
23 Sep 2011
Last updated
22 Nov 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Educational program: consultation with paediatric pulmonologist in people with Asthma, run by University Hospital, Clermont-Ferrand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUQUEI questionnaire (Asthma Caregiver's Quality of Life) (time frame: 3 or 4 months after the diagnosis of asthma). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2011.

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