ASTADEM: Asthma, Smoking, Emotional Deficits

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT03312673
Collaborator
(none)
70
1
17.5
4

Study Details

Study Description

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 Phase
  • Other: Interview and tests of drawing.

Study Design

Study Type:
Observational
Actual Enrollment :
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Asthma, Smoking, Emotional Deficits
Actual Study Start Date :
Nov 22, 2017
Actual Primary Completion Date :
May 10, 2019
Actual Study Completion Date :
May 10, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Poor control of asthma [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 [During routine visit (one hour and a half)]

    Defined by a score ≥ 44 points/100 on the Toronto scale

  3. Emotional deficit indicator traces [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 [During routine visit (one hour and a half)]

    Defined by a score ≥ 11 points on the HADS scale

  5. Anxiety [During routine visit (one hour and a half)]

    Defined by a score ≥ 11 points on the HADS scale

  6. Emotional valences [During routine visit (one hour and a half)]

    Defined by 8 scores distinct on Diener's subjective well-being scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service de Pneumologie Hôpital de la Croix-Rousse Lyon France 69004

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03312673
Other Study ID Numbers:
  • 69HCL17_0159
First Posted:
Oct 18, 2017
Last Update Posted:
Oct 15, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
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:

Study Results

No Results Posted as of Oct 15, 2019