RECETAS (Re-Imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) in Helsinki
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Change in health related quality of life
研究概览
简要总结
RECETAS (Re-imagining Environments for Connection and Engagement:
Testing Actions for Social Prescribing in Natural Spaces) is a worldwide project (H2020 No 945095) that addresses loneliness and the role of nature-based social intervention (NBSI) to alleviate it. Definitions: Loneliness is the perception of feeling alone, even if surrounded by people. Social prescription is a non-medical community referral approach to connect individuals with community resources to support wellbeing. Nature-based social intervention (NBSI) is a structured therapeutic groupbased social intervention that specifically include access to nature as a main component. Nature-based experiences may facilitate dynamic processes of social interactions and it can reduce feelings of loneliness.
Hypothesis: NBSI in vulnerable people suffering from loneliness is more effective than usual social and health care on improving their health-related quality of life and alleviating loneliness during 3-,6- and 12-months follow up.
Objectives: This trial aims to assess the effectiveness and to explore the processes and perceived impacts of NBSI in vulnerable people suffering from loneliness in the assisted living facilities in Helsinki. In Helsinki, the main objective is to assess the effectiveness of a 10-week NBSI (RCT) in vulnerable people suffering from loneliness on changes of their health-related quality of life (HRQOL) and loneliness compared to usual social and health care at end of intervention, and at 6-,and 12- months post-randomization.
Methods: The study design is a randomized controlled trial (RCT). The RCT will include also a process evaluation, a qualitative study and a Health Economics evaluation. Therefore, the RCT will use a mixed-method approach collecting quantitative information to assess the main outcomes and qualitative methods to explore lived experiences of participants and professionals.
The recruitment will be performed screening residents in Helsinki assisted living facilities by a survey. A total of 316 participants will be randomly allocated in two groups (c.158 each) after baseline assessments: intervention and control. Participants will sign the informed consent. The intervention is a group-based, multicomponent, behaviorally based complex intervention that requires a specific training to prepare professionals as facilitators. It is based on the "Circle of Friends" methodology.
详细描述
RECETAS (Re-imagining Environments for Connection and Engagement:
Testing Actions for Social Prescribing in Natural Spaces) is a worldwide project that addresses loneliness and the role of nature-based social intervention (NBSI) to alleviate it. This project has received funding from tte European Union's Horizon 2020 research and innovation under grant agreement No 945094. more information at: https://recetasproject.eu Background: Loneliness is the perception of feeling alone, even if surrounded by people. It is a growing public health concern due to its impact on morbidity and mortality even in old age, being as dangerous as smoking or obesity: it reduces people's lifespan, and it is associated with increased use of health and social services and it impairs people's quality-of-life. In Europe, 30 million European adults frequently felt lonely. Social prescription is a non-medical community referral approach to connect individuals with community resources to support wellbeing. Nature-based social intervention (NBSI) is a structured therapeutic group-based social intervention that specifically include access to nature as a main component. Nature-based experiences can facilitate dynamic processes of social interactions and it can reduce feelings of loneliness.
Justification: NBSI in urban areas may improve health and mental well-being and reduce loneliness. Investments in nature-based solutions and green infrastructure can be harnessed for health and wellbeing even in times of health emergencies (covid-19). NBSI offers a novel socio-environmental innovation to reduce loneliness by creating the social and technological infrastructure needed to support social and community cohesion.
Hypothesis: NBSI in vulnerable older people in assisted living facilities suffering from loneliness is more effective than usual social and health care on improving their quality of life and alleviating loneliness during 3-,6- and 12-months follow up.
Objectives: The study aims to assess the effectiveness and to explore the processes and perceived impacts of NBSI in vulnerable older people in assisted living facilities suffering from loneliness in the area of Helsinki. The main objective is to assess the effectiveness of a 10-week NBSI (RCT) in vulnerable people suffering from loneliness on the changes of loneliness and health-related quality of life compared to usual social and health care at 3-, 6-, and 12- months post-randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 55 years
- •Suffers from loneliness at least sometimes
- •lives permanently in assisted living facility
- •is voluntary to participate
- •has Minimental Examination at least 15 points or CPS <5 (not being moderately-severly cognitively impaired)
- •is able to move independently or dependently with or without assisting devices
- •sufficient sight and hearing to participate in group activities
排除标准
- •having a serious illness with a prognosis less than 6 months.
结局指标
主要结局
Change in health related quality of life
时间窗: From baseline to 3months, 6months, 12 months
15D health-related quality of life instrument. Minimum 0 (worst) and maximum 1 (best). 15D will be used as an index ( 0 to 1) and the changes in various 15 dimensions will also be explored.
Change in loneliness
时间窗: From baseline to 3months, 6months, 12 months
Modified De Jong Gierveld Loneliness Scale as a continuous scale (minimum 11 (best) and maximum 55 (worst))
次要结局
- Change in Psychological Wellbeing(From baseline to 3months, 6months, 12 months)
- Change in executive function(From baseline to 3months, 6months, 12 months)
- Change in cognition(From baseline to 3months, 6months, 12 months)
- Minimental State Examination(Only baseline)
- Change in self Efficacy(From baseline to 3months)
- Change in sleep quality(From baseline to 3months, 6months, 12 months)
- Change in attachment to neighbourhood(From baseline to 3months)
- Change in relationship with nature(From baseline to 3months)
- Change in frailty phenotype(Only baseline)
- Change in blood pressure(From baseline to 3months and 12 months)
- Use of health and social services(during 12 months from baseline)
- Health economic analyses (costs of health services with EQ5D-5L)(During 12 months (3mo, 6mo, 12mo))
- Change in social relationships(From baseline to 3months, 6months, 12 months)
- Repeated wellbeing before, during and after the intervention(Baseline, during the intervention and at 3 months)
- Repeated short measure of wellbeing(Baseline, during the intervention and at 3 months)
- Satisfaction with social relationships(Baseline, 3 months)
- Number and time spent on outdoor activities(3 months from baseline)
研究者
Kaisu Pitkala
PhD, Professor emerita
University of Helsinki