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

Primary Purpose

Nursing Home, Dementia, Staff

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Training on non-pharmacological therapies' methodology
Sponsored by
Associazione Ginco Ticino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nursing Home focused on measuring nursing home staff, behavioral symptoms, burnout

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fondazione Casa San Rocco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

San Rocco group

As usual control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Professional caregivers' burnout
Change in professional caregivers' burnout, as measured by the Maslach Burnout Inventory (MBI), from baseline to first and second follow up. The investigators expect a significant difference in the experimental group compared with the control group. The Maslach Burnout Inventory is a self-administered questionnaire with scores ranging from zero to 132, with higher scores indicating more severe burnout symptoms.
Professional caregivers' sense of competence
Change in the professional caregivers' sense of competence, as measured by the Sense of Competence in Dementia Care Staff Scale (SCDS), from baseline to first and second follow up. The investigators expect a significant difference in the experimental group compared to the control group. The Sense of Competence in Dementia Care Staff Scale is a self-administered questionnaire with scores ranging from 17 to 68, with higher scores indicating higher self-perception of competence.
Quality of life of people with dementia
Change 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 baseline to first and second follow up. The investigators expect a significant difference in the experimental group compared to the control group. The Quality of Life in Late-stage Dementia questionnaire is a self-administered questionnaire with scores ranging from 11 to 55, with higher scores indicating lower quality of life for people with dementia.
Professional caregivers' perception of social capital and ethical climate
Change in the professional caregivers' perception of social capital and ethical climate, as measured by the self-administered questionnaire Social capital and ethical climate at the Workplace of a hospital scale (SEW), from baseline to first and second follow up. The investigators expect a significant difference in the experimental group compared to the control group. The Social capital and ethical climate at the Workplace of a hospital scale is a self-administered questionnaire and it consists of three sub-scales: the higher the mean score of two sub-scales (social capital in the workplace and ethical leadership), the greater the participants' perceived favourable characteristics, and the higher the mean score of one sub-scale (exclusive workplace climate), the greater the participants' perceived unfavourable work environment characteristics.
Behavioral and psychological symptoms in dementia
Change in the behavioral and psychological symptoms in dementia (BPSD), as measured by the Neuropsychiatric Inventory Nursing Home (NPI-NH), from baseline to first and second follow up. TThe investigators expect a significant difference in the experimental group compared to the control group.The Neuropsychiatric Inventory Nursing Home was validated for interviewing the professional caregivers on twelve behavioural areas, including depression. The frequency [from one (rarely, less than once a week) to four (very often, once, or more per day)] and the severity [from one (mild) to three (severe)] of each BPSD are reported. The domain scores (frequency × severity) are added into the total score, ranging from zero to 144, with higher scores indicating more severe symptoms.

Full Information

First Posted
February 24, 2023
Last Updated
April 13, 2023
Sponsor
Associazione Ginco Ticino
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1. Study Identification

Unique Protocol Identification Number
NCT05814276
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Associazione Ginco Ticino

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nursing Home, Dementia, Staff
Keywords
nursing home staff, behavioral symptoms, burnout

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will attend ten sessions on the non-pharmacological therapies' methodology and implementation.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
San Rocco group
Arm Type
Experimental
Arm Description
The San Rocco study encompasses a training on the non-pharmacological therapies' methodology.
Arm Title
As usual control group
Arm Type
No Intervention
Arm Description
Participants will continue the usual care activities and non-pharmacological interventions already in use in the Nursing Homes without participating in the training.
Intervention Type
Behavioral
Intervention Name(s)
Training on non-pharmacological therapies' methodology
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to carry out non-pharmacological therapies
Description
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.
Time Frame
240 days
Title
Number of professional caregivers involved in non-pharmacological therapies
Description
To estimate the number of professional caregivers required to carry out the non-pharmacological therapies for people with dementia.
Time Frame
240 days
Secondary Outcome Measure Information:
Title
Professional caregivers' burnout
Description
Change in professional caregivers' burnout, as measured by the Maslach Burnout Inventory (MBI), from baseline to first and second follow up. The investigators expect a significant difference in the experimental group compared with the control group. The Maslach Burnout Inventory is a self-administered questionnaire with scores ranging from zero to 132, with higher scores indicating more severe burnout symptoms.
Time Frame
180 days
Title
Professional caregivers' sense of competence
Description
Change in the professional caregivers' sense of competence, as measured by the Sense of Competence in Dementia Care Staff Scale (SCDS), from baseline to first and second follow up. The investigators expect a significant difference in the experimental group compared to the control group. The Sense of Competence in Dementia Care Staff Scale is a self-administered questionnaire with scores ranging from 17 to 68, with higher scores indicating higher self-perception of competence.
Time Frame
180 days
Title
Quality of life of people with dementia
Description
Change 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 baseline to first and second follow up. The investigators expect a significant difference in the experimental group compared to the control group. The Quality of Life in Late-stage Dementia questionnaire is a self-administered questionnaire with scores ranging from 11 to 55, with higher scores indicating lower quality of life for people with dementia.
Time Frame
180 days
Title
Professional caregivers' perception of social capital and ethical climate
Description
Change in the professional caregivers' perception of social capital and ethical climate, as measured by the self-administered questionnaire Social capital and ethical climate at the Workplace of a hospital scale (SEW), from baseline to first and second follow up. The investigators expect a significant difference in the experimental group compared to the control group. The Social capital and ethical climate at the Workplace of a hospital scale is a self-administered questionnaire and it consists of three sub-scales: the higher the mean score of two sub-scales (social capital in the workplace and ethical leadership), the greater the participants' perceived favourable characteristics, and the higher the mean score of one sub-scale (exclusive workplace climate), the greater the participants' perceived unfavourable work environment characteristics.
Time Frame
180 days
Title
Behavioral and psychological symptoms in dementia
Description
Change in the behavioral and psychological symptoms in dementia (BPSD), as measured by the Neuropsychiatric Inventory Nursing Home (NPI-NH), from baseline to first and second follow up. TThe investigators expect a significant difference in the experimental group compared to the control group.The Neuropsychiatric Inventory Nursing Home was validated for interviewing the professional caregivers on twelve behavioural areas, including depression. The frequency [from one (rarely, less than once a week) to four (very often, once, or more per day)] and the severity [from one (mild) to three (severe)] of each BPSD are reported. The domain scores (frequency × severity) are added into the total score, ranging from zero to 144, with higher scores indicating more severe symptoms.
Time Frame
180 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Pezzati, Professor
Organizational Affiliation
Ginco Ticino Association
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Casa San Rocco
City
Morbio Inferiore
ZIP/Postal Code
6834
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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