Nursing HomeNCT05814276
San Rocco Study: Implementation of the Non-pharmacological Therapies for People With Dementia Living in Nursing Home
A study testing Training on non-pharmacological therapies' methodology in people with Nursing Home and Dementia, run by Associazione Ginco Ticino at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nursing Home, Dementia, Staff
- What is being tested?
- Training on non-pharmacological therapies' methodology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Feb 2022to 31 Jan 2023
- 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.
About this study
Official title: San Rocco Study: an Observational Study on Implementation of the Non-pharmacological Therapies for People With Dementia Living in Nursing Home
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:
Read more
- 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.
Read the 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.
- Conditions
- Nursing Home, Dementia, Staff
- Being tested
- Training on non-pharmacological therapies' methodology
- Keywords
- nursing home staff, behavioral symptoms, burnout
- Medical subject headings
- Dementia, Behavioral Symptoms, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training on non-pharmacological therapies' methodologyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| San Rocco group | Experimental | The San Rocco study encompasses a training on the non-pharmacological therapies' methodology. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 240 days
Secondary outcomes (5)
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.
Measured: 180 days
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.
Measured: 180 days
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.
Measured: 180 days
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.
Measured: 180 days
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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start11 Feb 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing HomeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will attend ten sessions on the non-pharmacological therapies' methodology and implementation.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
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
- NCT05814276
- Sponsor's protocol ID
- 02
- Status last verified
- Apr 2023
- First submitted
- 24 Feb 2023
- Last updated
- 14 Apr 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 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- San Rocco Study: an Observational Study on Implementation of the Non-pharmacological Therapies for People With Dementia Living in Nursing Home
- ClinicalTrials.gov ID
- NCT05814276
- Acronym / sponsor ID
- 02
- Conditions
- Nursing Home, Dementia, Staff
- Keywords
- nursing home staff, behavioral symptoms, burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Associazione Ginco TicinoUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 14 Apr 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will attend ten sessions on the non-pharmacological therapies' methodology and implementation.
| Arm | Type | Receives |
|---|---|---|
| San Rocco group | Experimental | Behavioral: Training on non-pharmacological therapies' methodologyThe San Rocco study encompasses a training 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 |
|---|---|---|
| Training on non-pharmacological therapies' methodologyThe 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. | Behavioural | San Rocco group |
Primary outcome
Time to carry out non-pharmacological therapies
Time frame: 240 days
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
Time frame: 240 days
To estimate the number of professional caregivers required to carry out the non-pharmacological therapies for people with dementia.
5 secondary outcomes
Professional caregivers' burnout
Time frame: 180 days
Professional caregivers' sense of competence
Time frame: 180 days
Quality of life of people with dementia
Time frame: 180 days
Professional caregivers' perception of social capital and ethical climate
Time frame: 180 days
Behavioral and psychological symptoms in dementia
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 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 Training on non-pharmacological therapies' methodology in people with Nursing Home 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: finished, as of the sponsor's last update on 14 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to carry out non-pharmacological therapies (time frame: 240 days). The study lists 2 primary outcomes in all. 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 14 Apr 2023.