Asthma Clinical Trial
— ASTADEMOfficial title:
Asthma, Smoking, Emotional Deficits
NCT number | NCT03312673 |
Other study ID # | 69HCL17_0159 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 22, 2017 |
Est. completion date | May 10, 2019 |
Verified date | October 2019 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | May 10, 2019 |
Est. primary completion date | May 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Service de Pneumologie Hôpital de la Croix-Rousse | Lyon |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Poor control of asthma | The poor asthma control is defined by a score <20 on the ACT test | During routine visit (one hour and a half) | |
Primary | Emotional deficit such as alexithymia | Defined by a score = 44 points/100 on the Toronto scale | During routine visit (one hour and a half) | |
Primary | Emotional deficit indicator traces | 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 | During routine visit (one hour and a half) | |
Primary | Depression | Defined by a score = 11 points on the HADS scale | During routine visit (one hour and a half) | |
Primary | Anxiety | Defined by a score = 11 points on the HADS scale | During routine visit (one hour and a half) | |
Primary | Emotional valences | Defined by 8 scores distinct on Diener's subjective well-being scale | During routine visit (one hour and a half) |
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