San Rocco Study: Implementation of the Non-pharmacological Therapies for People With Dementia Living in Nursing Home

Associazione Ginco Ticino

Status: Completed

Conditions: Staff; Dementia; Nursing Home

Treatments: Behavioral: Training on non-pharmacological therapies' methodology

Study type: Interventional

Funder types: Other

Identifiers

NCT05814276

02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 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: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

San Rocco group

Experimental group

Description:

The San Rocco study encompasses a training on the non-pharmacological therapies' methodology.

Treatment:

Behavioral: Training on non-pharmacological therapies' methodology

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.