NCT05710523

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of training on non-pharmacological therapies (NPT) for people with dementia (PWD) on professional caregivers burnout and well-being in the relationship between caregivers and people with dementia (PWD) living in nursing home. The main questions it aims to answer are:

  • Does I-ACE training, that includes a training in the emotional-behavioral reading of body language and the recognition of one's own emotions and those of others, reduces professional caregiver burnout?
  • Does I-ACE training improves the ability to understand and respond to the emotions of the other starting from the signals expressed by the eyes, the activation of the predisposition to the relationship in terms of increase of salivary oxytocin, the sense of competence of the carers, the ethical climate at the workplace and the quality of life of the resident perceived by the team? Participants will attend twenty-two sessions: two theoretical meetings on dementia and NPT; ten supervision meetings on the methodology for implementing non-pharmacological therapies based on discussions of cases; ten meetings on the exploration of the bodily aspects involved in the relationship through theatrical exercises. The same cases will be re-discussed in the light of the body-emotional approach. Researchers will compare the I-ACE group with an active control group and an usual care control group to see if there are improvements in term of professional caregivers burnout, their ability to understand and respond to the emotions of PWD, increase of their levels of salivary oxytocin, sense of competence of the carers, the ethical climate at the workplace and the quality of life of the resident perceived by the team.

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
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 8, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

3.6 years

First QC Date

January 24, 2023

Last Update Submit

January 24, 2023

Conditions

Keywords

burnoutnursing home staffdementiaoxytocinetraining

Outcome Measures

Primary Outcomes (1)

  • Professional caregivers' burnout

    Improvement in professional caregivers' burnout, as measured by the Maslach Burnout Inventory, from pre to post intervention. We expect a significant difference in the experimental group compared with the two control groups.

    547 days

Secondary Outcomes (5)

  • Professional caregivers' reading the mind in the eyes

    547 days

  • Salivary oxytocin of professional caregivers

    547 days

  • Professional caregivers' sense of competence

    547 days

  • professional caregivers' perception of social capital and ethical climate

    547 days

  • Quality of life of people with dementia

    547 days

Study Arms (3)

I-ACE training

EXPERIMENTAL

Participants will receive twenty-two sessions on the non-pharmacological therapies' methodology and on awareness of body language.

Behavioral: I-ACE training

Standard non-pharmacological therapies (NPT) training

ACTIVE COMPARATOR

Participants will receive twelve sessions on the non-pharmacological therapies' methodology.

Other: Standard non-pharmacological therapies (NPT) training

As usual control group

NO INTERVENTION

Participants will continue the usual care activities and non-pharmacological interventions already in use in the Nursing Homes without participating in the training.

Interventions

I-ACE trainingBEHAVIORAL

The I-ACE training encompasses a training on the non-pharmacological therapies' methodology and a training on awareness of body language which favors a passage from implicit to explicit knowledge. It allows the reading of the subjective relational experience of the care situation by the professional caregiver and a comparison of shared readings of the situation itself by the group of colleagues, and with the residents. Participants will follow: Two sessions, each lasting 4 hours, on theoretical introduction to the non-pharmacological therapies' methodology; Ten monthly supervisions, each lasting one and half hours, on discussion of clinical cases and implementation of the non-pharmacological therapies with person with dementia. Ten monthly supervisions, each lasting two hours, on theatrical exercises guided by an expert actor, with the help of a psychologist-psychotherapist who promotes understanding and awareness of self-reading in the relationship with the other.

I-ACE training

The standard NPT training encompasses a training on the non-pharmacological therapies' methodology. Participants will follow: Two sessions, each lasting 4 hours, on theoretical introduction to the non-pharmacological therapies' methodology; Ten monthly supervisions, each lasting one and half hours, on discussion of clinical cases and implementation of the non-pharmacological therapies with person with dementia.

Standard non-pharmacological therapies (NPT) training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Length of service more than six months.

You may not qualify if:

  • Presence of psychiatric illness or other medical condition that prevents participation in the training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuring Homes of Canton Ticino area

Lugano, Canton Ticino, Switzerland

RECRUITING

MeSH Terms

Conditions

Burnout, ProfessionalDementiaBurnout, Psychological

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Rita Pezzati, Professor

    Ginco Ticino Association

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The I-ACE training encompasses a training on the non-pharmacological therapies' methodology and a training on awareness of body language which favors a passage from implicit to explicit knowledge. It allows the reading of the subjective relational experience of the care situation by the professional caregiver and a comparison of shared readings of the situation itself by the group of colleagues, and with the residents. Participants will follow: Two sessions, each lasting 4 hours, on theoretical introduction to the non-pharmacological therapies' methodology; Ten monthly supervisions, each lasting one and half hours, on discussion of clinical cases and implementation of the non-pharmacological therapies with person with dementia. Ten monthly supervisions, each lasting two hours, on theatrical exercises guided by an expert actor, with the help of a psychologist-psychotherapist who promotes understanding and awareness of self-reading in the relationship with the other.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 2, 2023

Study Start

February 8, 2021

Primary Completion

August 30, 2024

Study Completion

February 28, 2025

Last Updated

February 2, 2023

Record last verified: 2023-01

Locations