Integration Between Learning, Body and Emotions (I-ACE)
I-ACE
Efficay of Training on Non-pharmacological Therapies With People With Dementia in Nursing Home: Integration Between Learning, Body and Emotions in Synergy (I-ACE). A Randomized Double-blind Controlled Study.
1 other identifier
interventional
270
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
January 24, 2023
CompletedFirst Posted
Study publicly available on registry
February 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedFebruary 2, 2023
January 1, 2023
3.6 years
January 24, 2023
January 24, 2023
Conditions
Keywords
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
EXPERIMENTALParticipants will receive twenty-two sessions on the non-pharmacological therapies' methodology and on awareness of body language.
Standard non-pharmacological therapies (NPT) training
ACTIVE COMPARATORParticipants will receive twelve sessions on the non-pharmacological therapies' methodology.
As usual control group
NO INTERVENTIONParticipants will continue the usual care activities and non-pharmacological interventions already in use in the Nursing Homes without participating in the training.
Interventions
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.
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rita Pezzati, Professor
Ginco Ticino Association
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
- 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