San Rocco Study: an Observational Study on Implementation of the Non-pharmacological Therapies for People With Dementia Living in Nursing Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Time to carry out non-pharmacological therapies
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •length of service more than six months
排除标准
- •Presence of psychiatric illness or other medical condition that prevents participation in the training
研究组 & 干预措施
San Rocco group
The San Rocco study encompasses a training on the non-pharmacological therapies' methodology.
干预措施: Training on non-pharmacological therapies' methodology (Behavioral)
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.
结局指标
主要结局
Time to carry out non-pharmacological therapies
时间窗: 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
时间窗: 240 days
To estimate the number of professional caregivers required to carry out the non-pharmacological therapies for people with dementia.
次要结局
- Professional caregivers' burnout(180 days)
- Quality of life of people with dementia(180 days)
- Professional caregivers' sense of competence(180 days)
- Professional caregivers' perception of social capital and ethical climate(180 days)
- Behavioral and psychological symptoms in dementia(180 days)