PsoriasisPRUERINCT04316533
Work Stress and Impact of Pruritus on Quality of Life
An observational study of Psoriasis, run by University Hospital, Brest at 1 site in France.
Trial summary
Work stress and pruritus: imbalance of effort balance reward in patients with psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2020to 30 Jun 2020
- 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: Active and employed population, suffering from psoriasis, presenting for consultation or hospitalization of dermatology at the CHRU of Brest
Who may be able to join
- Major patients
- Active busy patients with psoriasis presenting for a dermatology consultation or hospitalization at the Brest CHRU
- Participation agreement
Who cannot join
- Presence of another potentially pruritic pathology
- No command of the French language
- Patient under legal protection (guardianship, curatorship, etc.)
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Association Between Work Stress and the Impact of Pruritus on Quality of Life
Work stress and pruritus: imbalance of effort balance reward in patients with psoriasis.
Read the detailed description
Background. Stress increases the likelihood of psoriasis flare-up episodes and itching. Few studies have focused on work-related stress on such skin symptoms.
Objective. To study the association between work-related stress, pruritus and quality of life among workers suffering from psoriasis.
Methods. Investigators will conduct a monocentric non-interventional prospective study. Patients suffering from psoriasis will be recruited in both the Dermatology inpatient ward and outpatient clinic of Brest University Hospital . Included patients will be workers. Work-related stress will be assessed using the Effort-Reward Imbalance (ERI) model. The impact of pruritus on quality of life will be assessed with the Itchy Quality of Life (ItchyQoL) self-administered questionnaire. The collected data will include age, sex, body mass index, ordered medication to treat psoriasis, weekly working hours. The association between ERI and ItchyQoL scores will be studied using a univariate logistic regression.
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Occupational stress, Pruritus, Quality of life
- Medical subject headings
- Psoriasis, Occupational Stress, Pruritus
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus' impact on quality of life
The Itchy Quality of Life questionnaire (ItchyQoL) assess the quality of life linked to pruritus. It is a 22-item questionnaire wich assess the frequency of pruritus'symptoms in the past seven days. The score is between 22 and 110. The higher the score, the greater the impact of pruritus.
Measured: time required to complete the self questionnaire estimated at approximately 5 min immediately after consultation with the dermatologist
Secondary outcomes (1)
Occupational stress
The effort-reward imbalance questionnaire in 23-item for occupational stress. Six items make it possible to calculate the extrinsic efforts felt (score e) and eleven items assess the rewards perceived by the employee (score r). The ERI score is then calculated as follows: Ratio = (11 x e) / (6 x (66 - r)) (e: effort scale score, r: rewards scale score). A ratio greater than one indicates an imbalance in favor of efforts. The last six items make it possible to calculate the score for intrinsic efforts (over commitement). They relate to the inability to get away from work, impatience and disproportionate irritability.
Measured: time required to complete the self questionnaire estimated at approximately 5 min immediately after consultation with the dermatologist
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start9 Mar 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316533
- Sponsor's protocol ID
- 29BRC19.0263
- Acronym
- PRUERI
- Status last verified
- Jul 2020
- First submitted
- 6 Mar 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Association Between Work Stress and the Impact of Pruritus on Quality of Life
- ClinicalTrials.gov ID
- NCT04316533
- Acronym / sponsor ID
- PRUERI / 29BRC19.0263
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Occupational stress, Pruritus, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 20 Mar 2020 (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.
Work stress and pruritus: imbalance of effort balance reward in patients with psoriasis.
Detailed description
Background. Stress increases the likelihood of psoriasis flare-up episodes and itching. Few studies have focused on work-related stress on such skin symptoms.
Objective. To study the association between work-related stress, pruritus and quality of life among workers suffering from psoriasis.
Methods. Investigators will conduct a monocentric non-interventional prospective study. Patients suffering from psoriasis will be recruited in both the Dermatology inpatient ward and outpatient clinic of Brest University Hospital . Included patients will be workers. Work-related stress will be assessed using the Effort-Reward Imbalance (ERI) model. The impact of pruritus on quality of life will be assessed with the Itchy Quality of Life (ItchyQoL) self-administered questionnaire. The collected data will include age, sex, body mass index, ordered medication to treat psoriasis, weekly working hours. The association between ERI and ItchyQoL scores will be studied using a univariate logistic regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Active and employed population, suffering from psoriasis, presenting for consultation or hospitalization of dermatology at the CHRU of Brest
Key inclusion criteria (3 listed)
- Major patients
- Active busy patients with psoriasis presenting for a dermatology consultation or hospitalization at the Brest CHRU
- Participation agreement
Key exclusion criteria (4 listed)
- Presence of another potentially pruritic pathology
- No command of the French language
- Patient under legal protection (guardianship, curatorship, etc.)
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pruritus' impact on quality of life
Time frame: time required to complete the self questionnaire estimated at approximately 5 min immediately after consultation with the dermatologist
The Itchy Quality of Life questionnaire (ItchyQoL) assess the quality of life linked to pruritus. It is a 22-item questionnaire wich assess the frequency of pruritus'symptoms in the past seven days. The score is between 22 and 110. The higher the score, the greater the impact of pruritus.
1 secondary outcome
Occupational stress
Time frame: time required to complete the self questionnaire estimated at approximately 5 min immediately after consultation with the dermatologist
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 7 Jul 2020.
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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 Psoriasis, run by University Hospital, Brest 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 4 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 7 Jul 2020. 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?
Pruritus' impact on quality of life (time frame: time required to complete the self questionnaire estimated at approximately 5 min immediately after consultation with the dermatologist). 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 7 Jul 2020.