ClinicalTrials.gg
Status unknownNCT04291534ALADDINUpdated Nov 4, 2020

Quality of Life and Addiction Among Hospital Night Workers

An observational study in Health Services Research, Quality of Life and Addiction, sponsored by University Paris 7 - Denis Diderot. Status unknown at 2 sites in France. Open to participants aged 16 Years to 67 Years. Per ClinicalTrials.gov, last updated 2020-11-04.

Primary conditionSubstance-Related DisordersRegistry: Behavior, AddictiveReclassifiedWhy we changed it
Registry
Behavior, Addictive — the first condition term the registry derived for this study.
ClinicalTrials.gg
Substance-Related Disorders
Why
  1. Behavior, Addictive is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Substance-Related Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University Paris 7 - Denis Diderot · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
1,800
Ages
16 Years to 67 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Health Services Research
  • Quality of Life
  • Addiction
  • Substance-Related Disorders
  • Health Personnel

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03

In context

Substance-Related Disorders Reclassified

2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.

This study's planned enrollment of 1,800 is above the median of 251 across 299 observational studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

University Paris 7 - Denis Diderot is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Compared within Substance-Related Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Behavior, Addictive. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
16 Years to 67 Years
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • Hospital workers working during the day
  • Workers working less than 3 hours a night two time a week
  • Doctors
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
1,800 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Substance use prevalence

    Prevalence in APHP health workers of psychoactive substance consumption during the Covid 19 outbreak

    Time frame: at T0 month : baseline

  2. Quality of working life scale

    Evaluation of the quality of working life during the Covid 19 outbreak using a validated scale

    Time frame: at T0 month : baseline

Secondary outcomes

  1. 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.

    Time frame: at T0 month

  2. 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.

    Time frame: at T0 month

  3. 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

    Time frame: at T0 month

  4. Risk factors associated with tobacco use

    Describe the risk factors associated with tobacco use among night hospital workers,

    Time frame: at T0 month

  5. 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

    Time frame: at T0 month

  6. Impact of anxiety and depressive symptoms on sleep and QWL.

    Describe the links between QWL and sleep, anxiety, depressive syndromes, and workplace upheaval.

    Time frame: at T0 month

  7. 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.

    Time frame: at T month

  8. 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

    Time frame: T18 months

  9. 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

    Time frame: T18 months

07

Study locations

2 of 2 sites recruiting
  • Hôpital de Bicêtre
    Le Kremlin-Bicêtre, 94275, France
    Recruiting
  • Assistance Publique des Hopitaux de Paris
    Paris, 75004, France
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2020 (actual). Primary completion is estimated for Apr 2022, 21 months after the start.

Of 122 non-industry observational studies under Substance-Related Disorders, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 56. This study's planned 21 months is below that.

Counting every sponsor, half of 133 studies reached it within 36 months; a quarter within 18 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2020
First posted
Mar 2, 2020
StartActual
Jun 15, 2020
Primary completionEst.
Apr 1, 2022
CompletionEst.
Jun 1, 2023
Last update
Nov 4, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04291534
Lead sponsor
University Paris 7 - Denis Diderot
Responsible party
Dr Martin Duracinsky (Principal Investigator, University Paris 7 - Denis Diderot) — Principal investigator
First posted
Mar 2, 2020
Start date
Jun 15, 2020
Primary completion
Apr 1, 2022 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
Nov 4, 2020

Study contacts

Lorraine COUSIN, PhDc
Contact
cousinlorraine@gmail.comlorraine.cousin-ext@aphp.fr
0683586227
Olivia Rousset Torrente, MD
Contact
olivia.rousset-torrente-ext@aphp.fr
0140274689

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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