AsthmaASTADEMNCT03312673
Asthma, Smoking, Emotional Deficits
An observational study of Asthma and Emotional Disorder, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Emotional Disorder, Alexithymia
- What is being tested?
- Interview and tests of drawing.
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2017to 10 May 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asthma sufferers treated at the Croix Rousse hospital
Who may be able to join
- Men and women (> 18 years).
- Asthma (mild, moderate, severe).
- Beneficiary of social security
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Interview and tests of drawing.
- Medical subject headings
- Asthma, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Asthma population | Patients (men and women) asthmatic smokers and non-smokers followed routinely in the pulmonology department, Croix-Rousse Hospital, Hospices Civils of Lyon. Receives: Other: Interview and tests of drawing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poor control of asthma
The poor asthma control is defined by a score <20 on the ACT test
Measured: During routine visit (one hour and a half)
Emotional deficit such as alexithymia
Defined by a score ≥ 44 points/100 on the Toronto scale
Measured: 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
Measured: During routine visit (one hour and a half)
Depression
Defined by a score ≥ 11 points on the HADS scale
Measured: During routine visit (one hour and a half)
Anxiety
Defined by a score ≥ 11 points on the HADS scale
Measured: During routine visit (one hour and a half)
Emotional valences
Defined by 8 scores distinct on Diener's subjective well-being scale
Measured: During routine visit (one hour and a half)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start22 Nov 2017
- Primary completion10 May 2019
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312673
- Sponsor's protocol ID
- 69HCL17_0159
- Acronym
- ASTADEM
- Status last verified
- Oct 2019
- First submitted
- 4 Oct 2017
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma, Smoking, Emotional Deficits
- ClinicalTrials.gov ID
- NCT03312673
- Acronym / sponsor ID
- ASTADEM / 69HCL17_0159
- Conditions
- Asthma, Emotional Disorder, Alexithymia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma population | – | Other: Interview and tests of drawing.Patients (men and women) asthmatic smokers and non-smokers followed routinely in the pulmonology department, Croix-Rousse Hospital, Hospices Civils of Lyon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthma sufferers treated at the Croix Rousse hospital
Key inclusion criteria (3 listed)
- Men and women (> 18 years).
- Asthma (mild, moderate, severe).
- Beneficiary of social security
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Asthma population |
Primary outcome
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
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
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
Depression
Time frame: During routine visit (one hour and a half)
Defined by a score ≥ 11 points on the HADS scale
Anxiety
Time frame: During routine visit (one hour and a half)
Defined by a score ≥ 11 points on the HADS scale
Emotional valences
Time frame: During routine visit (one hour and a half)
Defined by 8 scores distinct on Diener's subjective well-being scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Emotional Disorder, run by Hospices Civils de Lyon at 1 site in France.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Poor control of asthma (time frame: During routine visit (one hour and a half)). The study lists 6 primary outcomes in all. 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 15 Oct 2019.