Health Services ResearchALADDINNCT04291534
Quality of Life and Addiction Among Hospital Night Workers
An observational study of Health Services Research and Quality of Life, run by University Paris 7 - Denis Diderot at 2 sites in France.
Trial summary
The current context of the Covid-19 health crisis leads to an over-solicitation of health systems, with hospital staff in the front line. These personnel are undergoing high levels of stress, an alteration of their life rhythm, but also of their health status and quality of life at work. Read more about this study
- Who is it for?
- Ages 16 to 67 years
- Conditions the study is for
- Health Services Research, Quality of Life, Addiction
- How many people
- 1,800 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jun 2020to 1 Jun 2023
- 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 16 to 67 years
- All sexes
- Child, Adult, Older adult
Study population: As night workers are more prone to impaired health and to addictions, the study focuses on hospital night workers who represent a population particularly at risk.
Who may be able to join
- hospital workers at APHP, working at night or night and day alternance (working at least 3 hours between 9 p.m and 6 a.m, 2 times a week)
Who cannot join
- Hospital workers working during the day
- Workers working less than 3 hours a night two time a week
- Doctors
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Hôpital de Bicêtre
Le Kremlin-Bicêtre, 94275
Françoise Churaqui, 0145217438 ext. 33, francoise.churaqui@aphp.fr
Aïchata F Dara, MD, 0140275544 ext. 33, adara.proqol@gmail.com
- Recruiting
Assistance Publique des Hopitaux de Paris
Paris, 75004
Lorraine COUSIN, PhDc, 0144841777, lorraine.cousin-ext@aphp.fr
About this study
Official title: Quality of Life and Addiction Among Hospital Night Workers - Descriptive Study of APHP Workers in Paris
The current context of the Covid-19 health crisis leads to an over-solicitation of health systems, with hospital staff in the front line. These personnel are undergoing high levels of stress, an alteration of their life rhythm, but also of their health status and quality of life at work. In addition, night work, through the disruption of circadian rhythms, has consequences on physical and mental health. The more frequent worsening of the condition of certain patients at night increases the burden and responsibilities of night staff. Increasing the use of psychoactive substances (SPAs) can become a solution for managing stress, work rhythms, sleep disorders and their consequences. This self-medication behaviour is not without risks, neither for staff nor for patients.
The ALADDIN study is a project made up of 2 waves of questionnaires - one during and the other after the Covid "hospital" crisis - filled in by the hospital night staff of AP-HP. This project will assess the impact of the Covid-19 epidemic on the quality of work life, mental health disorders, post-traumatic stress and substance use of hospital night staff.
Read more
The main objectives of this study is to evaluate the prevalence of psychoactive substance consumption among the night shift healthcare workers of the AP-HP and to describe the participants' quality of working life.
Methods The study is prospective study using an online self-completed questionnaire. The questionnaire was elaborated on the basis of the validated scales ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test), AUDIT-C (Alcohol Use Disorder Test, shortened version) and HAD (for anxiety and depression) and on qualitative interviews conducted among care staff working the night shift.
The questionnaire will be completed at t0 (baseline) and 18 months after. This study will provide data on the consumption psychoactive substances by night hospital workers adn their quality of working life. It will also allow us to compare their consumption with the general population, and to describe the risk factors influencing the consumption.
- Conditions
- Health Services Research, Quality of Life, Addiction, Substance-Related Disorders, Health Personnel
- Medical subject headings
- Behavior, Addictive, Substance-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use prevalence
Prevalence in APHP health workers of psychoactive substance consumption during the Covid 19 outbreak
Measured: at T0 month : baseline
Quality of working life scale
Evaluation of the quality of working life during the Covid 19 outbreak using a validated scale
Measured: at T0 month : baseline
Secondary outcomes (9)
Intervention preference
Identify the preferences for intervention to improve the quality of life or change the addictive risk of night hospital staff at the APHP. Preferences for intervention methods and ranking of the least preferred.
Measured: at T0 month
Psychoactive substance consumption and associated factors
Describe the risk factors associated with the consumption of psychoactive substances (PAS).
Logistic or fish linear regression depending on the type of variable taken into account.
Measured: at T0 month
Impact of substance consumption on quality of life at work
Evaluate the impact of substance use on quality of life at work Principal component analysis and classification to see if there are consumer groups for the night and / or day population. Method for taking into account missing, unused or invalid data
Measured: at T0 month
Risk factors associated with tobacco use
Describe the risk factors associated with tobacco use among night hospital workers,
Measured: at T0 month
Impact of sleep quality on quality of working life and perceived health
Evaluate the impact of sleep quality on the quality of working life and perceived health of night staff
Measured: at T0 month
Impact of anxiety and depressive symptoms on sleep and QWL.
Describe the links between QWL and sleep, anxiety, depressive syndromes, and workplace upheaval.
Measured: at T0 month
Impact of sleep and workplace upheaval on anxiety and depressives symptoms
Describe the links between anxiety/depressive syndromes and workplace disruption, sleep, and the Covid epidemic.
Measured: at T month
Modification of quality of working life score and psychoactive substances consumption prevalences
Comparison between the baseline score and prevalences and the score and prevalences 18 months after
Measured: T18 months
Comparison of modification of quality of life score and declared quality of life modification after 18 month
Analysis of the relation between declared change and evolution of the quality of life score
Measured: T18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start15 Jun 2020
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Services ResearchStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Paris 7 - Denis Diderot
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Assistance Publique - Hôpitaux de Paris
- Responsible party
- Principal investigator, Dr Martin Duracinsky, University Paris 7 - Denis Diderot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291534
- Sponsor's protocol ID
- ALADDIN-QoLHospWork
- Acronym
- ALADDIN
- Status last verified
- Nov 2020
- First submitted
- 4 Feb 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Addiction Among Hospital Night Workers - Descriptive Study of APHP Workers in Paris
- ClinicalTrials.gov ID
- NCT04291534
- Acronym / sponsor ID
- ALADDIN / ALADDIN-QoLHospWork
- Conditions
- Health Services Research, Quality of Life, Addiction, Substance-Related Disorders, Health Personnel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- University Paris 7 - Denis DiderotUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Assistance Publique - Hôpitaux de Paris
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 2 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.
The current context of the Covid-19 health crisis leads to an over-solicitation of health systems, with hospital staff in the front line. These personnel are undergoing high levels of stress, an alteration of their life rhythm, but also of their health status and quality of life at work. In addition, night work, through the disruption of circadian rhythms, has consequences on physical and mental health. The more frequent worsening of the condition of certain patients at night increases the burden and responsibilities of night staff. Increasing the use of psychoactive substances (SPAs) can become a solution for managing stress, work rhythms, sleep disorders and their consequences. This self-medication behaviour is not without risks, neither for staff nor for patients.
The ALADDIN study is a project made up of 2 waves of questionnaires - one during and the other after the Covid "hospital" crisis - filled in by the hospital night staff of AP-HP. This project will assess the impact of the Covid-19 epidemic on the quality of work life, mental health disorders, post-traumatic stress and substance use of hospital night staff.
The main objectives of this study is to evaluate the prevalence of psychoactive substance consumption among the night shift healthcare workers of the AP-HP and to describe the participants' quality of working life.
Methods The study is prospective study using an online self-completed questionnaire. The questionnaire was elaborated on the basis of the validated scales ASSIST (Alcohol, Smoking, and Substance Involvement Screening Test), AUDIT-C (Alcohol Use Disorder Test, shortened version) and HAD (for anxiety and depression) and on qualitative interviews conducted among care staff working the night shift.
The questionnaire will be completed at t0 (baseline) and 18 months after. This study will provide data on the consumption psychoactive substances by night hospital workers adn their quality of working life. It will also allow us to compare their consumption with the general population, and to describe the risk factors influencing the consumption.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 67 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- As night workers are more prone to impaired health and to addictions, the study focuses on hospital night workers who represent a population particularly at risk.
Key inclusion criteria (1 listed)
- hospital workers at APHP, working at night or night and day alternance (working at least 3 hours between 9 p.m and 6 a.m, 2 times a week)
Key exclusion criteria (3 listed)
- Hospital workers working during the day
- Workers working less than 3 hours a night two time a week
- Doctors
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
Substance use prevalence
Time frame: at T0 month : baseline
Prevalence in APHP health workers of psychoactive substance consumption during the Covid 19 outbreak
Quality of working life scale
Time frame: at T0 month : baseline
Evaluation of the quality of working life during the Covid 19 outbreak using a validated scale
9 secondary outcomes
Intervention preference
Time frame: at T0 month
Psychoactive substance consumption and associated factors
Time frame: at T0 month
Impact of substance consumption on quality of life at work
Time frame: at T0 month
Risk factors associated with tobacco use
Time frame: at T0 month
Impact of sleep quality on quality of working life and perceived health
Time frame: at T0 month
Impact of anxiety and depressive symptoms on sleep and QWL.
Time frame: at T0 month
Impact of sleep and workplace upheaval on anxiety and depressives symptoms
Time frame: at T month
Modification of quality of working life score and psychoactive substances consumption prevalences
Time frame: T18 months
Comparison of modification of quality of life score and declared quality of life modification after 18 month
Time frame: T18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Services Research and Quality of Life, run by University Paris 7 - Denis Diderot at 2 sites 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 1 inclusion and 3 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 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Lorraine COUSIN, PhDc (0683586227, cousinlorraine@gmail.comlorraine.cousin-ext@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance use prevalence (time frame: at T0 month : baseline). The study lists 2 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 4 Nov 2020.