Burnout, ProfessionalI-ACENCT05710523
Integration Between Learning, Body and Emotions (I-ACE)
A study testing I-ACE training and Standard non-pharmacological therapies (NPT) training in people with Burnout, Professional and Dementia, run by Associazione Ginco Ticino at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burnout, Professional, Dementia, Quality of Life
- What is being tested?
- I-ACE training and Standard non-pharmacological therapies (NPT) training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Feb 2021to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Length of service more than six months.
Who cannot join
- Presence of psychiatric illness or other medical condition that prevents participation in the training.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Nuring Homes of Canton Ticino area
Lugano, Canton Ticino
Daniele Stival, daniele.stival@ti.ch
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Burnout, Professional, Dementia, Quality of Life
- Being tested
- I-ACE training, Standard non-pharmacological therapies (NPT) training
- Keywords
- burnout, nursing home staff, dementia, oxytocine, training
- Medical subject headings
- Burnout, Professional, Dementia, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-ACE trainingBehavioural
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.
Standard non-pharmacological therapies (NPT) trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| I-ACE training | Experimental | Participants will receive twenty-two sessions on the non-pharmacological therapies' methodology and on awareness of body language. Receives: Behavioral: I-ACE training |
| Standard non-pharmacological therapies (NPT) training | Active comparator | Participants will receive twelve sessions on the non-pharmacological therapies' methodology. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 547 days
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 547 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start8 Feb 2021
- Primary completion30 Aug 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associazione Ginco Ticino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita Pezzati, Professor, Principal investigator, Ginco Ticino Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710523
- Sponsor's protocol ID
- 01
- Acronym
- I-ACE
- Status last verified
- Jan 2023
- First submitted
- 24 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05710523
- Acronym / sponsor ID
- I-ACE / 01
- Conditions
- Burnout, Professional, Dementia, Quality of Life
- Keywords
- burnout, nursing home staff, dementia, oxytocine, training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Associazione Ginco TicinoUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| I-ACE training | Experimental | Behavioral: I-ACE trainingParticipants will receive twenty-two sessions on the non-pharmacological therapies' methodology and on awareness of body language. |
| Standard non-pharmacological therapies (NPT) training | Active comparator | Other: Standard non-pharmacological therapies (NPT) trainingParticipants will receive twelve sessions on the non-pharmacological therapies' methodology. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Length of service more than six months.
Key exclusion criteria (1 listed)
- Presence of psychiatric illness or other medical condition that prevents participation in the training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-ACE trainingThe 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. | Behavioural | I-ACE training |
| Standard non-pharmacological therapies (NPT) trainingThe 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. | Other | Standard non-pharmacological therapies (NPT) training |
Primary outcome
Professional caregivers' burnout
Time frame: 547 days
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.
5 secondary outcomes
Professional caregivers' reading the mind in the eyes
Time frame: 547 days
Salivary oxytocin of professional caregivers
Time frame: 547 days
Professional caregivers' sense of competence
Time frame: 547 days
professional caregivers' perception of social capital and ethical climate
Time frame: 547 days
Quality of life of people with dementia
Time frame: 547 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Pezzati, Professor principal investigator
Ginco Ticino Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-ACE training and Standard non-pharmacological therapies (NPT) training in people with Burnout, Professional and Dementia, run by Associazione Ginco Ticino at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberta Vaccaro (+393394904237, rvaccaro.gincoitalia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Professional caregivers' burnout (time frame: 547 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023; AzTrials last refreshed its copy on 28 Oct 2026.