Effects of Nature-based Group Intervention on Quality-of-life in Lonely Older People Living in Assisted Living Facities

Loneliness Clinical Trial

— RECETAS  

Official title:

RECETAS (Re-Imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) in Helsinki

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05507684
• Other study ID #: 945095 HEL
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: May 2023
• Source: University of Helsinki
• Contact: Kaisu H Pitkälä, MD, PhD
• Phone: +358503385546
• Email: kaisu.pitkala[@]helsinki.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. Methods: The study design is a randomized controlled trial (RCT). The RCT will also include a process evaluation, a qualitative study and a health economics evaluation. Therefore, overall, 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 by screening residents in Helsinki assisted living facilities by a survey inclusing 1500 residents. Inclusion criteria will be age 65+ years, suffering from loneliness, living permanently in assisted living facility, being voluntary to participate, having Minimental Examination at least 15 point (not being moderately-severly cognitively impaired), being able to move independently with or without assisting devices, sufficient sight and hearing and not having a seirous illnes with a prognosis than 6 months. 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 developed in Helsinki University. Participants in the intervention arm meet in closed groups including 5-12 participants once a week for 9 times. The group activities include nature-based activities and discussions on them and participants' loneliness. The groups facilitators will use group dynamics to facilitate participants' mutual interaction and to support their self-efficacy. Control group participants will receive usual care, and a list of nature-based resources available in their area. Main outcome measures will be changes in loneliness by De Jong Gierveld Loneliness scale and health-related quality-of-life by 15D measure. Secondary measures will be changes in wellbeing (Psychological Wellbeing scale), EuroQual 5D-5L, cognition (Minimental State examination, Clock-drawing test, verbal fluency), walking speed and frailty (Physical frailty), self efficacy (Generalized Self-Efficacy scale), sleep quality, attachment ot neighbourhood (12 Neighborhood Assessment Scale), and relationship with nature (NR-6). THe use of health and social services will be collected from central records and health economic analyses performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 316
• Est. completion date: February 28, 2026
• Est. primary completion date: February 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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 Exclusion Criteria: having a serious illness with a prognosis less than 6 months.

Related Conditions & MeSH terms

• Loneliness

Intervention

Other:
• Nature-based social prescribing group intervention
Groups of 5-12 persons will formed from one assisted living facility. All of them will undergo an individual interview to assess their wishes for the nature-based activities. Participants meet in a closed group for 9 times once a week for 10 weeks. All 2-4 hour sessions will include nature-based activities and mutual discussions about the experiences of nature and loneliness. 2 professionals will facilitate and observe the group more thoroughly, give feedback to each other, and make use of group dynamics. They write diaries on each session and receive feedback from their trainers. The groups are objective oriented (aiming to alleviate loneliness, to improve participants' self-efficacy), client oriented and aim with favorable group dynamics to mature, self-directing group in which the participants have made friends with each other and want meet with each other without the facilitators after the official group intervention is over.

Locations

Country	Name	City	State
Finland	Helsinki City assisted living facilities	Helsinki

Sponsors (4)

Lead Sponsor	Collaborator
University of Helsinki	Barcelona Institute of Global Health, Helsinki City Older People's Services, The Finnish Association for the Welfare of Older People

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Group participants' opinions	Group participants' opinions about the group activities and its impact on loneliness and social relationships	during the group and at 3 months
Primary	Change in health related quality of life	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.	From baseline to 3months, 6months, 12 months
Primary	Change in loneliness	De Jong Gierveld Loneliness Scale (minimum 0 (best) and maximum 11 (worst))	From baseline to 3months, 6months, 12 months
Secondary	Change in Psychological Wellbeing	Psychological Wellbeing Scale by Routasalo et al. 2009 (Minimum 0 (worst) and maximum 1 (best).	From baseline to 3months, 6months, 12 months
Secondary	Change in executive function	Clock Drawing test (Minimum 0 (worst) and maximum 6 (best).	From baseline to 3months, 6months, 12 months
Secondary	Change in cognition	Verbal Fluency (Minimum 0 (worst) and maximum >30 (best)).	From baseline to 3months, 6months, 12 months
Secondary	Change in global cognition	Minimental State Examination (Minimum 0 (worst) and maximum 30 (best).)	From baseline to 3months, 6months, 12 months
Secondary	Change in self Efficacy	Generalized Self-Efficacy scale by Schwarzer & Jerusalem 1995	From baseline to 3months
Secondary	Change in frailty phenotype	Physical frailty	From baseline to 3months
Secondary	Change in blood pressure	Blood pressure	From baseline to 3months
Secondary	Change in sleep quality	One item questions	From baseline to 3months, 6months, 12 months
Secondary	Change in attachment to neighbourhood	Neighborhood Assessment Scale	From baseline to 3months
Secondary	Change in relationship with nature	Questions related to nature attitudes	From baseline to 3months
Secondary	Use of health and social services	Use of health and social services retrieved from registers	during 12 months from baseline
Secondary	Health economic analyses (costs of health services with EQ5D-5L)	EuroQOL 5D-5L	During 12 months (3mo, 6mo, 12mo)
Secondary	Change in social relationships	Number of new friends, continuation of group activity, satisfaction with relationships	From baseline to 3months, 6months, 12 months
Secondary	Repeated wellbeing before, during and after the intervention	4 items related to psychological and physical wellbeing	Baseline, during the intervention and at 3 months
Secondary	Repeated short measure of wellbeing	4 items related to psychological and physical wellbeing	Baseline, during the intervention and at 3 months
Secondary	Satisfaction with social relationships	Items on social relationships and social activity	Baseline, 3 months
Secondary	Number and time spent on outdoor activities	Number of outdoor activities and time spent there during the intervention	3 months from baseline