Attention Deficit Hyperactivity Disorder in AdultsWORKTDANCT04020120
Assessment of the Professional Difficulties of Adult With Attention Deficit / Hyperactivity Disorder Patients
An observational study of Attention Deficit Hyperactivity Disorder in Adults, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Attention Deficit/Hyperactivity Disorder (ADHD), which is common and well known in children, persists into adulthood in more than 60% of cases, with significant impact on quality of life. Professional domain is particularly impaired. Read more about this study
- Who is it for?
- Ages 18 to 62 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder in Adults
- What is being tested?
- questionnaires
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2019to Dec 2021
- 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 to 62 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who consulted at the psychiatric clinic of Strasbourg, aged 18 to 62, with a diagnosis of attention deficit disorder with or without hyperactivity assessed by a psychiatrist, and who have been in a working situation in the last 3 months.
Who may be able to join
- Patients aged 18 to 62 years
- Diagnosis of attention deficit disorder with or without hyperactivity by a psychiatrist
- No treatment for ADHD in childhood or adolescence
- Patient who has been in a professional situation during the last 3 months
Who cannot join
- Patient on sick leave or unemployed for more than 3 months
- Depressive episode in acute phase
- Subject with a mobility project that prevents follow-up for 1 year (planned move)
- Impossibility of providing the subject with informed information (subject in an emergency situation, difficulties in understanding the subject, mental retardation, illiteracy or insufficient command of the French language...)
- Subject under the protection of justice
- Subject under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Sébastien WEIBEL, +33 3 88 11 51 57, sebastien.weibel@chru-strasbourg.fr
Sébastien WEIBEL
About this study
Official title: Impact of Adult With Attention Deficit / Hyperactivity Disorder on Professional Activity, a Prospective Cohort Study
Attention Deficit/Hyperactivity Disorder (ADHD), which is common and well known in children, persists into adulthood in more than 60% of cases, with significant impact on quality of life. Professional domain is particularly impaired.
The investigators hypothesize that ADHD symptoms causes professional difficulties, on the emotional, cognitive, physical and relational levels.
Read more
The main objective of this study is to better characterize these professional difficulties at to follow-up these difficulties after one year. Difficulties will be assessed by questionnaires and semi-directive interview.
The secondary objective is to determine what factors modulate these difficulties and what compensation strategies are implemented to address the patients.
- Being tested
- questionnaires
- Keywords
- Prospective, Descriptive, Non-interventional, Monocentric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
answer questionnaires
| Study group | Role | What they receive |
|---|---|---|
| ADHD in professional activity | Adult ADHD patients in active employment at the time of inclusion or who were in employment within 3 months prior to inclusion Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Work Limitations Questionnaire (WLQ-25)
It is a questionnaire with 25 items exploring 4 distinct dimensions: time management, physical demands, mental interpersonal demands and output demands.
Measured: 1 year
Secondary outcomes (1)
Maslach Burnout Inventory
It is a questionnaire with 22 items exploring 3 distinct dimensions: emotional exhaustion, deshumanization and personal achievement at work
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study startDec 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder in AdultsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020120
- Sponsor's protocol ID
- 7482
- Acronym
- WORKTDA
- Status last verified
- Nov 2019
- First submitted
- 11 Jul 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adult With Attention Deficit / Hyperactivity Disorder on Professional Activity, a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04020120
- Acronym / sponsor ID
- WORKTDA / 7482
- Keywords
- Prospective, Descriptive, Non-interventional, Monocentric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Jul 2019 (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.
Attention Deficit/Hyperactivity Disorder (ADHD), which is common and well known in children, persists into adulthood in more than 60% of cases, with significant impact on quality of life. Professional domain is particularly impaired.
The investigators hypothesize that ADHD symptoms causes professional difficulties, on the emotional, cognitive, physical and relational levels.
The main objective of this study is to better characterize these professional difficulties at to follow-up these difficulties after one year. Difficulties will be assessed by questionnaires and semi-directive interview.
The secondary objective is to determine what factors modulate these difficulties and what compensation strategies are implemented to address the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHD in professional activity | – | Other: questionnairesAdult ADHD patients in active employment at the time of inclusion or who were in employment within 3 months prior to inclusion |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who consulted at the psychiatric clinic of Strasbourg, aged 18 to 62, with a diagnosis of attention deficit disorder with or without hyperactivity assessed by a psychiatrist, and who have been in a working situation in the last 3 months.
Key inclusion criteria (4 listed)
- Patients aged 18 to 62 years
- Diagnosis of attention deficit disorder with or without hyperactivity by a psychiatrist
- No treatment for ADHD in childhood or adolescence
- Patient who has been in a professional situation during the last 3 months
Key exclusion criteria (6 listed)
- Patient on sick leave or unemployed for more than 3 months
- Depressive episode in acute phase
- Subject with a mobility project that prevents follow-up for 1 year (planned move)
- Impossibility of providing the subject with informed information (subject in an emergency situation, difficulties in understanding the subject, mental retardation, illiteracy or insufficient command of the French language...)
- Subject under the protection of justice
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 |
|---|---|---|
| questionnairesanswer questionnaires | Other | ADHD in professional activity |
Primary outcome
The Work Limitations Questionnaire (WLQ-25)
Time frame: 1 year
It is a questionnaire with 25 items exploring 4 distinct dimensions: time management, physical demands, mental interpersonal demands and output demands.
1 secondary outcome
Maslach Burnout Inventory
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France
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 Attention Deficit Hyperactivity Disorder in Adults, run by University Hospital, Strasbourg, France 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Work Limitations Questionnaire (WLQ-25) (time frame: 1 year). 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 13 Nov 2019.