Clinical trial NCT05814276: San Rocco Study: Implementation of the Non-pharmacological Therapies for People With Dementia Living in Nursing Home
Official title: San Rocco Study: an Observational Study on Implementation of the Non-pharmacological Therapies for People With Dementia Living in Nursing Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Home
Dementia
Staff
Keywords: nursing home staff
behavioral symptoms
burnout
Lead sponsor: Associazione Ginco Ticino
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will attend ten sessions on the non-pharmacological therapies' methodology and implementation.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goals of this clinical trial are 1) to estimate the number of professional caregivers and the time spent to carry out the non-pharmacological therapies for people with dementia and 2) to evaluate differences between professional caregivers trained and non-trained to non-pharmacological therapies for people with dementia in term of caregivers' burnout and well-being of people with dementia living in nursing home.

The main questions it aims to answer are:

* How long does it take professional caregivers to implement and carry out non-pharmacological therapies?
* How many caregivers are needed to start and carry out non-pharmacological therapies?
* Do the non-pharmacological therapies improve the quality of life of people with dementia?
* Do the non-pharmacological therapies reduce behavioral and psychological symptoms of dementia?
* Do the non-pharmacological therapies improve professional caregiver burnout, sense of competence and ethical climate in nursing home?
* Do the non-pharmacological therapies reduce family caregivers' stress?

Participants will attend ten sessions:

* five theoretical meetings on dementia and non-pharmacological therapies;
* five supervision meetings on the methodology for implementing non-pharmacological therapies based on discussions of cases.

The investigators will compare the experimental group with an usual care control group to see if there are improvements in term of the quality of life of the resident perceived by the team, professional caregivers burnout, sense of competence of the carers and the ethical climate at the workplace.

Detailed description: The San Rocco study is a case-control study with two parallel arms aimed to estimate the number of professional caregivers and the time spent to carry out the non-pharmacological therapies for people with dementia and to evaluate the three- and six-months effectiveness of a training on non-pharmacological interventions, compared to usual care activities. Investigators have planned to involve two convenience samples. Experimental group: 18 professional caregivers and 18 people with dementia living in the San Rocco Special Care Unit for people with dementia (Canton of Ticino, Switzerland). Control group: 18 professional caregivers of the Nursing Homes attending the non-active group of the I-ACE study (ClinicalTrials.gov ID: NCT05710523).

The Nursing Homes' responsibles 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to carry out non-pharmacological therapies
timeFrame: 240 days
measure: Number of professional caregivers involved in non-pharmacological therapies
timeFrame: 240 days
Secondary outcomes:
measure: Professional caregivers' burnout
timeFrame: 180 days
measure: Professional caregivers' sense of competence
timeFrame: 180 days
measure: Quality of life of people with dementia
timeFrame: 180 days
measure: Professional caregivers' perception of social capital and ethical climate
timeFrame: 180 days
measure: Behavioral and psychological symptoms in dementia
timeFrame: 180 days
Other outcomes:
Locations:
city: Morbio Inferiore
country: Switzerland
facility: Fondazione Casa San Rocco
Study officials:
affiliation: Ginco Ticino Association
name: Rita Pezzati, Professor
role: PRINCIPAL_INVESTIGATOR
References: