Clinical trial NCT06727682: Feasibility of Stress Management Education Delivered Via Virtual Classroom in Nursing Homes: a Pilot Study of a RCT
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Occupational Stress
Keywords: stress management
virtual classroom
risk of burnout
behavioural and psychological symptoms of dementia
Lead sponsor: GCS CIPS
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Participation rate
timeFrame: From enrollment to the end of the study at 3 months
Secondary outcomes:
measure: Acceptance rate
timeFrame: At enrollment
measure: Retention rate
timeFrame: From enrollment to the end of the study at 3 months
measure: Adherence
timeFrame: From the beginning to the end of the study, at 3 months
measure: Quality of the intervention
timeFrame: At the end of the intervention, at 3 months
measure: Cost of the programme
timeFrame: From enrollment to the end of the study at 3 months
measure: Heart rate variability
timeFrame: Baseline and 3 months
measure: Occupational stress
timeFrame: Baseline, 2 months and 3 months
measure: Overall stress
timeFrame: Baseline, 2 months and 3 months
measure: Job satisfaction
timeFrame: Baseline, 2 months and 3 months
measure: Risk of burn-out
timeFrame: Baseline, 2 months and 3 months
measure: Quality of life
timeFrame: Baseline, 2 months and 3 months
measure: Self-rated health
timeFrame: Baseline, 2 months and 3 months
measure: Anxiety
timeFrame: Baseline, 2 months and 3 months
measure: Perceptions of the quality of patient care
timeFrame: Baseline, 2 months and 3 months
measure: Substance use
timeFrame: Baseline, 2 months and 3 months
measure: Knowledge and mastery of stress management tools
timeFrame: Baseline, 2 months and 3 months
Other outcomes:
measure: Residents' level of agitation in the specialised care units
timeFrame: Baseline and 3 months
measure: Health-related quality of life of residents in the specialised care units
timeFrame: Baseline and 3 months
measure: Behavioural and psychological symptoms of dementia in the residents of the specialised care units
timeFrame: Baseline and 3 months
Locations:
city: Saint-Cyr-l'École
country: France
facility: Korian Parc de l'abbaye
state: Ile-de-France
city: Saint-Germain-en-Laye
country: France
facility: Korian Parc des dames
state: Ile-de-France
city: Narbonne
country: France
facility: Korian Le Clos de l'orchidée
state: Occitanie
city: Gigean
country: France
facility: Korian La Colombe
Study officials:
affiliation: France Chief Medical Officer, Clariane
name: Fariba Kabirian, MD
role: PRINCIPAL_INVESTIGATOR
References: