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

NCT05814276 | Completed

• 1 other identifier: 02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Nursing Home; Dementia; Staff

Keywords

nursing home staff; behavioral symptoms; burnout

Outcome Measures

Primary Outcomes (2)

• Time to carry out non-pharmacological therapies

  To estimate how much time (i.e., minutes per day) the professional caregivers take to carry out the non-pharmacological therapies for people with dementia.

  240 days

• Number of professional caregivers involved in non-pharmacological therapies

  To estimate the number of professional caregivers required to carry out the non-pharmacological therapies for people with dementia.

  240 days

Secondary Outcomes (5)

• Professional caregivers' burnout

  180 days

• Professional caregivers' sense of competence

  180 days

• Quality of life of people with dementia

  180 days

• Professional caregivers' perception of social capital and ethical climate

  180 days

• Behavioral and psychological symptoms in dementia

  180 days

Study Arms (2)

San Rocco group

EXPERIMENTAL

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

Behavioral: Training on 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.

Interventions

Training on non-pharmacological therapies' methodology BEHAVIORAL

The San Rocco study encompasses a training on the non-pharmacological therapies' methodology. It allows the professional caregiver to methodological definition of the non-pharmacological interventions and a comparison of shared readings of the challenging behaviors by the group of colleagues. Participants will follow: * Five meetings, lasting 11 hours overall, on the multidimensional assessment, the shared readings of behavioral disorders of each person and identification of the objectives through the discussion of cases, and administration of non-pharmacological therapies within the framework of the personalization of the interventions * Five meetings, lasting five and a half hours, for the supervision of the staff which implement the non-pharmacological therapies. 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.

San Rocco group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• length of service more than six months

You may not qualify if:

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

Sponsors & Collaborators

• Associazione Ginco Ticino: lead

Study Sites (1)

Fondazione Casa San Rocco

Morbio Inferiore, 6834, Switzerland

Location

MeSH Terms

Conditions

Dementia; Behavioral Symptoms; Burnout, Psychological

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior; Stress, Psychological

Study Officials

• Rita Pezzati, Professor

  Ginco Ticino Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will attend ten sessions on the non-pharmacological therapies' methodology and implementation.

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: April 14, 2023
• Study Start: February 11, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

CH (1)