CClinicalTrials.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.

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has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.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
03

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.

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
04

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
1,800 participants (estimated)
Patient registry
No
05

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

06

Study locations

2 of 2 sites recruiting
07

Registry details

Key details

Study ID
NCT04291534
Lead sponsor
University Paris 7 - Denis Diderot
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Assistance Publique - Hôpitaux de Paris
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 ↗

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