NCT04291534

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.8 years

First QC Date

February 4, 2020

Last Update Submit

November 2, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Substance use prevalence

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

    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

    at T0 month : baseline

Secondary Outcomes (9)

  • Intervention preference

    at T0 month

  • Psychoactive substance consumption and associated factors

    at T0 month

  • Impact of substance consumption on quality of life at work

    at T0 month

  • Risk factors associated with tobacco use

    at T0 month

  • Impact of sleep quality on quality of working life and perceived health

    at T0 month

  • +4 more secondary outcomes

Eligibility Criteria

Age16 Years - 67 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital de Bicêtre

Le Kremlin-Bicêtre, 94275, France

RECRUITING

Assistance Publique des Hopitaux de Paris

Paris, 75004, France

RECRUITING

MeSH Terms

Conditions

Behavior, AddictiveSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorChemically-Induced DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 4, 2020

First Posted

March 2, 2020

Study Start

June 15, 2020

Primary Completion

April 1, 2022

Study Completion

June 1, 2023

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations