Feasibility of Stress Management Education Delivered Via Virtual Classroom in Nursing Homes: a Pilot Study of a RCT (AGIT-RESTS-1)

Feasibility and Relevance of Stress Management Education Delivered Via Virtual Classroom for Carers Working in Specialised Care Units in Nursing Homes: a Pilot Study of a Randomized Controlled Trial

The aim of this cluster-randomised pilot study is to assess the feasibility of a remote stress management programme to reduce occupational stress in healthcare workers in specialised care units of nursing homes. Secondary aims are to assess the effectiveness of the programme in reducing stress in care workers and reducing behavioural and psychological symptoms of dementia in residents.

Participants randomised to the experimental cluster will follow the stress management programme delivered in a virtual classroom. Participants randomised to the control cluster will be placed on a waiting list.

The primary outcome measure will be the participation rate in the study. Other secondary outcomes will include measures of heart rate variability (as a marker of physiological stress) and scores on specific questionnaires for stress, anxiety and risk of burnout in nursing staff in the specialised care units, and behavioural and psychological symptoms of dementia and quality of life in residents in the specialised care units.

Both clusters will complete the same assessments. Participants in the experimental cluster will follow a three-course programme with a psychologist via videoconferencing over a period of 2 months. After the study's final evaluation visit, which will take place one month after the programme, participants in the control cluster will be offered the opportunity to follow the same programme.

Study Overview

• Status: Completed
• Conditions: Occupational Stress
• Intervention / Treatment: Behavioral: Stress management

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gigean, France, 34770
    • Korian La Colombe
  • Ile-de-France
    • Saint-Cyr-l'École, Ile-de-France, France, 78210
      • Korian Parc de l'abbaye
    • Saint-Germain-en-Laye, Ile-de-France, France
      • Korian Parc des dames
  • Occitanie
    • Narbonne, Occitanie, France, 11100
      • Korian Le Clos de l'orchidée

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Having a caring relationship with residents (e.g. nurses, nursing assistants)
• Working in the specialised care unit of the nursing home
• Working in the nursing home for at least 3 months on the date of inclusion and whose employment contract does not end within 3 months of the date of inclusion.
• Obtaining express written informed consent, after a period of reflection

Exclusion Criteria:

• Person in a period of relative exclusion in relation to another protocol
• Person who is not affiliated to or does not benefit from a social security scheme.
• Pregnant or lactating woman
• Participant unable to give consent
• Person deprived of liberty by judicial or administrative decision
• Person unable to understand, speak, read and write French

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote stress management programme; Ten-hour, three-course stress management programme with a psychologist via video conferencing over 2 months	Behavioral: Stress management; Ten-hour, three-course stress management programme with a psychologist via video conferencing over a 2 month period. The classes will be delivered in small groups of maximum seven care workers. Carers can be brought together in the same room, but the speaker will necessarily be at a distance, via videoconferencing. The formation will adress the following issues: i) Understanding the mechanisms of stress, ii) Identifying sources of stress and triggers, iii) Anticipate stressful situations and use their resources to prevent them, and iv) Use the most appropriate stress-reduction techniques, depending on their sensitivity.
No Intervention: Waiting list; No intervention during the study duration. However, after the end of the study, after the last evaluations, participants in this control cluster will be offered the opportunity to follow the stress management programme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation rate	Participation rate defined as the ratio of the number of participants who completed all study visits to the number of care professionals who agreed to participate.	From enrollment to the end of the study at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance rate	Ratio between the total number of eligible healthcare workers and the number of healthcare worker who accept to be enrolled in the study.	At enrollment
Retention rate	Ratio between the number of care professionals still present at the last visit of the study and the number of care professionals included in the study	From enrollment to the end of the study at 3 months
Adherence	Average number of visits attended by each participant.	From the beginning to the end of the study, at 3 months
Quality of the intervention	Feedback on the relevance of the training and its contribution through semi-directive interviews and focus groups in participants and in managers and directors of the nursing homes.	At the end of the intervention, at 3 months
Cost of the programme	Total cost of the stress management program including the costs incurred to enable the employee to follow the training and/or the costs incurred to replace the absence of the employee in the service	From enrollment to the end of the study at 3 months
Heart rate variability	Recording of resting heart rate variability assessed by RMSSD, SDNN, LF and HF markers.	Baseline and 3 months
Occupational stress	Score on the Work Place Stress Scale	Baseline, 2 months and 3 months
Overall stress	Score on the Perceived Stress Scale-10	Baseline, 2 months and 3 months
Job satisfaction	Score on the Overall Job Satisfaction Scale	Baseline, 2 months and 3 months
Risk of burn-out	Score on the Malasch Burnout Inventory	Baseline, 2 months and 3 months
Quality of life	Score on the World Health Organization Quality of Life questionnaire	Baseline, 2 months and 3 months
Self-rated health	Score on the self-rated health scale	Baseline, 2 months and 3 months
Anxiety	Score on the Generalized Anxiety Disorder 7-Item	Baseline, 2 months and 3 months
Perceptions of the quality of patient care	Score on the Victorian Patient Satisfaction Questionnaire	Baseline, 2 months and 3 months
Substance use	Usual substance use (tobacco, alcohol, drugs...), assessed by a questionnaire that records the type of substance and frequency of use.	Baseline, 2 months and 3 months
Knowledge and mastery of stress management tools	Score on a multiple-choice questionnaire specially designed for the study	Baseline, 2 months and 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residents' level of agitation in the specialised care units	Perceived residents' level of agitation by the healtcare workers assessed by the score on the Cohen-Mansfield Agitation Inventory	Baseline and 3 months
Health-related quality of life of residents in the specialised care units	Residents' health-related quality of life as perceived by healthcare workers, as assessed by scores on the 'Quality of Life in Late Stage Dementia' questionnaire.	Baseline and 3 months
Behavioural and psychological symptoms of dementia in the residents of the specialised care units	Residents' behavioural and psychological symptoms of dementia as perceived by healthcare workers, as assessed by the "Neuropsychiatric inventory" questionnaire	Baseline and 3 months

Collaborators and Investigators

• Sponsor: GCS CIPS
• Investigators: Principal Investigator: Fariba Kabirian, MD, France Chief Medical Officer, Clariane

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Actual): May 22, 2025
• Study Completion (Actual): May 22, 2025

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: stress management; virtual classroom; risk of burnout; behavioural and psychological symptoms of dementia
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Occupational Stress
• Other Study ID Numbers: AGIT-RESTS-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No