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.

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Burnout, Professional; Dementia
• Intervention / Treatment: Behavioral: I-ACE training; Other: Standard non-pharmacological therapies (NPT) training

Detailed Description

The I-ACE study is a complex, single-center, randomized, controlled, single-blind experimental study with three parallel arms: I-ACE training (experimental group), standard NPT training (active control group), and a usual care group. The study aims to evaluate the effectiveness of a year and a half NPT training that includes a theoretical-experiential dimension on the body (I-ACE training), compared to a standard NPT training, and usual care activities. The study involves the professional caregivers of the Nursing Homes of the Canton of Ticino.

Participants in I-ACE study are professional caregivers of 15 Nursing Home in Canton Ticino area. The Nursing Home's responsibles will identify participants responding to inclusion criteria with the help of Principal investigator. The study coordinator (responsible Professor Rita Pezzati) will verify the presence of the inclusion and exclusion criteria. This information will be promptly transferred and kept in an electronic archive protected by a password. Access to the personal computer containing the data will be protected by an access key. In the database, to each subject will be assigned an identification code without references to personal data, which will be kept separately and protected by a keyword known only to the research manager or his delegate. The list of codes relating to the Nursing Homes and the eligible subjects will be delivered to the researcher who will arrange for the randomization. After generating the randomisation sequence, an independent researcher will forward it to the study coordinator for the assignment of the Nursing Homes to each of the three groups, experimental, active control and as usual control (block size (5 x 3 = 15).

In line with similar studies (Gómez-Gascón et al., 2013; Verweij et al., 2018) we have planned three parallel arms with 90 subjects per arm, an estimated medium effect size (d = 0.05), an alpha level of 0.05, and a power of 0.91. Thereafter, a 10% attrition rate due to possible acute clinical conditions interfering with the participation in the study was considered. The power calculation was performed with the programme G*Power 3.1.

• Study Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberta Vaccaro; Phone Number: +393394904237; Email: rvaccaro.gincoitalia@gmail.com

Study Locations

• Switzerland
  • Canton Ticino
    • Lugano, Canton Ticino, Switzerland
      • Recruiting
      • Nuring Homes of Canton Ticino area
      • Contact: Daniele Stival; Email: daniele.stival@ti.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Length of service more than six months.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: I-ACE training; Participants will receive twenty-two sessions on the non-pharmacological therapies' methodology and on awareness of body language.	Behavioral: I-ACE training; 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.
ACTIVE_COMPARATOR: Standard non-pharmacological therapies (NPT) training; Participants will receive twelve sessions on the non-pharmacological therapies' methodology.	Other: Standard non-pharmacological therapies (NPT) 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.
NO_INTERVENTION: As usual control group; Participants will continue the usual care activities and non-pharmacological interventions already in use in the Nursing Homes without participating in the training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Professional caregivers' reading the mind in the eyes	Improvement in the ability of professional caregivers to understand and respond to the emotions of the other starting from the signals expressed by the eyes, as measured by the Reading the mind in the eyes test, from pre to post intervention. We expect a significant difference in the experimental group compared to the two control groups.	547 days
Salivary oxytocin of professional caregivers	Improvement in the salivary oxytocin of professional caregivers, from pre to post intervention. We expect a significant difference in the experimental group compared to the two control groups.	547 days
Professional caregivers' sense of competence	Improvement in the professional caregivers' sense of competence, as measured by the Dementia Care Staff Sense of Competence in Dementia Care Staff Scale, from pre to post intervention. We expect a significant difference in the experimental group compared to the two control groups.	547 days
professional caregivers' perception of social capital and ethical climate	Improvement in the professional caregivers' perception of social capital and ethical climate, as measured by the Social capital and ethical climate at the Workplace of a hospital scale (SEW), from pre to post intervention. We expect a significant difference in the experimental group compared to the two control groups.	547 days
Quality of life of people with dementia	Improvement in the quality of life of people with dementia perceived from professional caregivers, as measured by the Quality of Life in Late-stage Dementia questionnaire (QUALID), from pre to post intervention. We expect a significant difference in the experimental group compared to the two control groups.	547 days

Collaborators and Investigators

• Sponsor: Associazione Ginco Ticino

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2021
• Primary Completion (ANTICIPATED): August 30, 2024
• Study Completion (ANTICIPATED): February 28, 2025

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (ACTUAL): February 2, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: dementia; training; burnout; nursing home staff; oxytocine
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Stress, Psychological; Occupational Stress; Occupational Diseases; Burnout, Professional; Burnout, Psychological; Dementia
• Other Study ID Numbers: 01 (Miami VAHS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No