Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04291534
Other study ID # ALADDIN-QoLHospWork
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 15, 2020
Est. completion date June 1, 2023

Study information

Verified date November 2020
Source University Paris 7 - Denis Diderot
Contact Lorraine COUSIN, PhDc
Phone 0683586227
Email cousinlorraine@gmail.comlorraine.cousin-ext@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1800
Est. completion date June 1, 2023
Est. primary completion date April 1, 2022
Accepts healthy volunteers
Gender All
Age group 16 Years to 67 Years
Eligibility 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: - Hospital workers working during the day - Workers working less than 3 hours a night two time a week - Doctors

Study Design


Locations

Country Name City State
France Hôpital de Bicêtre Le Kremlin-Bicêtre
France Assistance Publique des Hopitaux de Paris Paris

Sponsors (3)

Lead Sponsor Collaborator
University Paris 7 - Denis Diderot Assistance Publique - Hôpitaux de Paris, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Substance use prevalence Prevalence in APHP health workers of psychoactive substance consumption during the Covid 19 outbreak at T0 month : baseline
Primary 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 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. at T0 month
Secondary 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.
at T0 month
Secondary 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 at T0 month
Secondary Risk factors associated with tobacco use Describe the risk factors associated with tobacco use among night hospital workers, at T0 month
Secondary 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 at T0 month
Secondary Impact of anxiety and depressive symptoms on sleep and QWL. Describe the links between QWL and sleep, anxiety, depressive syndromes, and workplace upheaval. at T0 month
Secondary 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. at T month
Secondary 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 T18 months
Secondary 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 T18 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT06238557 - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04281953 - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting NCT05546931 - Mobile Health Program for Rural Hypertension N/A
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Recruiting NCT04142827 - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) N/A
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT03813420 - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level N/A
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Terminated NCT03304184 - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life Phase 3
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Recruiting NCT05380856 - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction N/A