Feasibility of Stress Management Education Delivered Via Virtual Classroom in Nursing Homes: a Pilot Study of a RCT

NCT06727682 | Completed

• 1 other identifier: AGIT-RESTS-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Occupational Stress

Keywords

stress management; virtual classroom; risk of burnout; behavioural and psychological symptoms of dementia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Acceptance rate

  At enrollment

• Retention rate

  From enrollment to the end of the study at 3 months

• Adherence

  From the beginning to the end of the study, at 3 months

• Quality of the intervention

  At the end of the intervention, at 3 months

• Cost of the programme

  From enrollment to the end of the study at 3 months

Other Outcomes (3)

• Residents' level of agitation in the specialised care units

  Baseline and 3 months

• Health-related quality of life of residents in the specialised care units

  Baseline and 3 months

• Behavioural and psychological symptoms of dementia in the residents of the specialised care units

  Baseline and 3 months

Study Arms (2)

Remote stress management programme

EXPERIMENTAL

Ten-hour, three-course stress management programme with a psychologist via video conferencing over 2 months

Behavioral: Stress management

Waiting list

NO INTERVENTION

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.

Interventions

Stress management BEHAVIORAL

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.

Remote stress management programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a caring relationship with residents (e.g. nurses, nursing assistants)
• Working in the specialised care unit of the nursing home
• Obtaining express written informed consent, after a period of reflection

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS CIPS: lead

Study Sites (4)

Korian La Colombe

Gigean, France, 34770, France

Location

Korian Le Clos de l'orchidée

Narbonne, Occitanie, 11100, France

Location

Korian Parc de l'abbaye

Saint-Cyr-l'École, Île-de-France Region, 78210, France

Location

Korian Parc des dames

Saint-Germain-en-Laye, Île-de-France Region, France

Location

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Fariba Kabirian, MD

  France Chief Medical Officer, Clariane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomised pilot study with four specialised care units of nursing homes and two clusters. Two specialised care units will be randomized in the experimental cluster, and the other ones will be randomized in the control cluster.

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 11, 2024
• Study Start: December 2, 2024
• Primary Completion: May 22, 2025
• Study Completion: May 22, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

FR (4)