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Asthma, Smoking, Emotional Deficits (ASTADEM)

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ClinicalTrials.gov Identifier: NCT03312673
Recruitment Status : Not yet recruiting
First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
The objective of the study is to determine whether poor control of asthma is related to an emotional deficit such as alexithymia. The hypothesis is that there is a correlation between the severity of asthma, its control, and the degree of emotional deficits.

Condition or disease Intervention/treatment
Asthma Emotional Disorder Alexithymia Other: Interview and tests of drawing.

Study Type : Observational
Estimated Enrollment : 99 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Asthma, Smoking, Emotional Deficits
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
Asthma population
Patients (men and women) asthmatic smokers and non-smokers followed routinely in the pulmonology department, Croix-Rousse Hospital, Hospices Civils of Lyon.
Other: Interview and tests of drawing.
The intervention will take place with patients followed for asthma at the Croix Rousse hospital. Patients agreeing to participate in the study will come to the hospital for one hour and a half. They will answer questionnaires and tests of drawing. Results Restitution Session (optional) is proposed to patients within the next 4 weeks during a routine consultation.




Primary Outcome Measures :
  1. Poor control of asthma [ Time Frame: During routine visit (one hour and a half) ]
    The poor asthma control is defined by a score <20 on the ACT test

  2. Emotional deficit such as alexithymia [ Time Frame: During routine visit (one hour and a half) ]
    Defined by a score ≥ 44 points/100 on the Toronto scale

  3. Emotional deficit indicator traces [ Time Frame: During routine visit (one hour and a half) ]
    Identifying indicator traces of emotional deficits according to the dimensions defining the alexithymia on the test of the tree and the drawing of the person

  4. Depression [ Time Frame: During routine visit (one hour and a half) ]
    Defined by a score ≥ 11 points on the HADS scale

  5. Anxiety [ Time Frame: During routine visit (one hour and a half) ]
    Defined by a score ≥ 11 points on the HADS scale

  6. Emotional valences [ Time Frame: During routine visit (one hour and a half) ]
    Defined by 8 scores distinct on Diener's subjective well-being scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Asthma sufferers treated at the Croix Rousse hospital
Criteria

Inclusion Criteria:

  • Men and women (> 18 years).
  • Asthma (mild, moderate, severe).
  • Beneficiary of social security

Exclusion Criteria:

  • Pregnant women
  • Patients who oppose their participation in the study
  • Multiple drug users (psychoactive substances).
  • Patients with severe psychiatric antecedents and comorbidities.
  • Patients with cancer
  • Patients with cognitive impairment
  • Patients with speech, hearing, visual, and praxic disorders.
  • Any chronic and especially respiratory pathology other than asthma (COPD, bronchiectasis), which can alter the study.
  • Patients not speaking French
  • Persons protected by law

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 ClinicalTrials.gov identifier (NCT number): NCT03312673


Contacts
Contact: Gilles DEVOUASSOUX, Pr 04 26 73 29 47 ext +33 gilles.devouassoux@chu-lyon.fr
Contact: Lydia FERNANDEZ, Pr lydia.fernandez@univ-lyon2.fr

Locations
France
Service de Pneumologie Hôpital de la Croix-Rousse Not yet recruiting
Lyon, France, 69004
Contact: Gilles DEVOUASSOUX, Pr    04 26 73 29 47 ext +33    gilles.devouassoux@chu-lyon.fr   
Contact: Lydia FERNANDEZ, Pr       lydia.fernandez@univ-lyon2.fr   
Principal Investigator: Gilles DEVOUASSOUX, Pr         
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03312673     History of Changes
Other Study ID Numbers: 69HCL17_0159
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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