Integration Between Learning, Body and Emotions (I-ACE)

Associazione Ginco Ticino

Status: Enrolling

Conditions: Quality of Life; Burnout, Professional; Dementia

Treatments: Other: Standard non-pharmacological therapies (NPT) training; Behavioral: I-ACE training

Study type: Interventional

Funder types: Other

Identifiers

NCT05710523

01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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270 participants in 3 patient groups

I-ACE training

Experimental group

Description:

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

Treatment:

Behavioral: I-ACE training

Standard non-pharmacological therapies (NPT) training

Active Comparator group

Description:

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

Treatment:

Other: Standard non-pharmacological therapies (NPT) training

As usual control group

No Intervention group

Description:

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