Asthma, Smoking, Emotional Deficits

NCT03312673 | Completed

• 1 other identifier: 69HCL17_0159
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Emotional Disorder; Alexithymia

Outcome Measures

Primary Outcomes (6)

• 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)

• Emotional deficit such as alexithymia

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

  During routine visit (one hour and a half)

• 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)

• Depression

  Defined by a score ≥ 11 points on the HADS scale

  During routine visit (one hour and a half)

• Anxiety

  Defined by a score ≥ 11 points on the HADS scale

  During routine visit (one hour and a half)

• Emotional valences

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

  During routine visit (one hour and a half)

Study Arms (1)

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.

Interventions

Interview and tests of drawing. OTHER

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.

Asthma population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Asthma sufferers treated at the Croix Rousse hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Pneumologie Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

MeSH Terms

Conditions

Asthma; Affective Symptoms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 18, 2017
• Study Start: November 22, 2017
• Primary Completion: May 10, 2019
• Study Completion: May 10, 2019
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)