Testing the Effectiveness of a Nature-based Social Intervention on Loneliness Among Lonely Adults in Prague - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- De Jong Gierveld Loneliness Scale 11 item
研究概览
简要总结
RECETAS (Re-imagine Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is an European project (H2020 No 945095) that aims to reduce loneliness by linking lonely pople to nature-based social actvitities through a group-based intervention.
Background: Loneliness is a person's own perception when his/her need for satisfying social contact and relationships is not met. The feeling of loneliness can be experienced even by a person who is surrounded by people. RECETAS aims to design and test nature-based socila itervention (NBSI) that is group-based and includes access to nature as a main component. The testing will be conducted in six different citites: Barcelona, Helsinki, Prague, Marseille, Cuenca in Ecuador and Melbourne. If succesful, this will provide an evidence-based approach for using social prescribing to address loneliness.
Objectives: to assess the effectiveness of a 10-week NBSI on loneliness and health-related quality of life in vulnerable people in the area of Prague suffering from it compared to usual social and health care at post-intervention, and at 6-, and 12-months post-randomization.
A pilot study was conducted from May to June 2022 prior to the start of the study in January 2023. The main aim of the pilot study was to identify barriers and obstacles to conducting the trial itself.
Methods: The study design is a randomized controlled trial (RCT) including a process evaluation based on Medical health Council guidance, a nested qualitative study and a Health Economics evaluation.
Participants will be recruited mainly from primary care settings (health and social), third sector organisations, community groups, and volunteer organisations. A total of 316 participants will be randomly allocated in two arms after the baseline assessment: NBSI tratment and control arms. All of them will be asked to sign the informed consent form.
详细描述
RECETAS (Re-imagine Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is project that adresses loneliness and the role of nature-based social prescription (NBSP) to reduce it. This project has received funding from European Union's Horizon research and innovation under grant agreement No 945094. More information at: https://recetasproject.eu/
Background: Loneliness is a person's own perception when his/her need for satisfying social contact and relationships is not met. The feeling of loneliness can be experienced even by a person who is surrounded by people. Loneliness is a modifiable health condition that is potentially dangerous to health and can reduce people's life span. In Europe, 30 million people European adults frequently felt lonely.
Social prescription is a non-medical approach that aims to connect people with the community through social outdoor activities to improve their wellbeing. NBSP is an intervention where nature-based social activities connect people, places and institutions that form strong social networks and connections. Nature-based activities can facilitate a dynamic process and social interactions and can thus contribute to reducing feelings of loneliness. We will design and test nature-based social intervention (NBSI) that is group-based and includes access to nature as a main component. The testing will be conducted in six urban areas: Barcelona, Helsinki, Prague, Cuenca in Ecuador and Melbourne.
Objectives: to assess the effectiveness of a 10-week NBSI on loneliness and health-related quality of life in vulnerable people in the area of Prague suffering from it compared to usual social and health care at post-intervention, and at 6-, and 12-months post-randomization.
A pilot study was conducted from May to June 2022 prior to the start of the study in January 2023. The main aim of the pilot study was to identify barriers and obstacles to conducting the trial itself.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to give informed consent in Czech
- •Older adults (60+) with a risk of social isolation and loneliness
- •Currently experiencing loneliness according to the screening question "Do you suffer from loneliness?"
- •Willing to undergo study measurement.
排除标准
- •Unable to go outdoors due to poor mobility or severe diseases.
- •Poor hearing or sight in case it prevents them to participate of the group dynamics and activities in the nature.
- •Severe, moderate or mild cognitive decline.
- •Any mental health disorders that might interfere with the group dynamics.
- •Severe disease with poor prognosis < 6 months.
结局指标
主要结局
De Jong Gierveld Loneliness Scale 11 item
时间窗: Post-intervention (10 weeks)
Change in loneliness. De Jong Gierveld Loneliness Scale (minimum 0 (best) and maximum 11 (worst))
15D instrument of health-related quality of life
时间窗: Post-intervention (10 weeks)
Change in health related quality of life. 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.
次要结局
- EURO-QOL 5D-5L(From baseline to 3months, 6months, 12 months)
- Psychological Wellbeing Scale by Routasalo et al. 2009(From baseline to 3months, 6months, 12 months)
- Clock drawing test(From baseline to 3months, 6months, 12 months)
- Instrumental Activities of Daily Living Scale(From baseline to 3months, 6months, 12 months)
- 15D instrument of health-related quality of life(Baseline (before intervention), 6- and 12-months follow up)
- De Jong Gierveld Loneliness Scale 11 item(Baseline (before intervention), 6- and 12-months follow up)
- International Physical Activity Questionnaire(From baseline to 3months, 6months, 12 months)
- Geriatric Depression Scale(From baseline to 3months, 6months, 12 months)
- Lubben Social Network Scale(From baseline to 3months, 6months, 12 months)
- ICEpop CAPability mesure for Adults (ICECAP-A)(From baseline to 3months, 6months, 12 months)
- Nature connection index(From baseline to 3months, 6months, 12 months)
研究者
Vladimíra Dostálová
Senior researcher
Charles University, Czech Republic