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NCT Number: NCT05507684

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

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki City assisted living facilities

Helsinki, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nature-based social prescribing group intervention

Other

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.

Primary outcomes

  1. Change in health related quality of life

    Time frame: 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.

  2. Change in loneliness

    Time frame: From baseline to 3months, 6months, 12 months

    Modified De Jong Gierveld Loneliness Scale as a continuous scale (minimum 11 (best) and maximum 55 (worst))

Secondary outcomes

  1. Change in Psychological Wellbeing

    Time frame: From baseline to 3months, 6months, 12 months

    Psychological Wellbeing Scale by Routasalo et al. 2009 (Minimum 0 (worst) and maximum 1 (best).

  2. Change in executive function

    Time frame: From baseline to 3months, 6months, 12 months

    Clock Drawing test (Minimum 0 (worst) and maximum 6 (best).

  3. Change in cognition

    Time frame: From baseline to 3months, 6months, 12 months

    Verbal Fluency (Minimum 0 (worst) and maximum >30 (best)).

  4. Minimental State Examination

    Time frame: Only baseline

  5. Change in self Efficacy

    Time frame: From baseline to 3months

    Generalized Self-Efficacy scale by Schwarzer & Jerusalem 1995

  6. Change in frailty phenotype

    Time frame: Only baseline

    Physical frailty

  7. Change in blood pressure

    Time frame: From baseline to 3months and 12 months

    Blood pressure

  8. Change in sleep quality

    Time frame: From baseline to 3months, 6months, 12 months

    One item questions

  9. Change in attachment to neighbourhood

    Time frame: From baseline to 3months

    Neighborhood Assessment Scale

  10. Change in relationship with nature

    Time frame: From baseline to 3months

    Questions related to nature attitudes

  11. Use of health and social services

    Time frame: during 12 months from baseline

    Use of health and social services retrieved from registers

  12. Health economic analyses (costs of health services with EQ5D-5L)

    Time frame: During 12 months (3mo, 6mo, 12mo)

    EuroQOL 5D-5L

  13. Change in social relationships

    Time frame: From baseline to 3months, 6months, 12 months

    Number of new friends, continuation of group activity, satisfaction with relationships

  14. Repeated wellbeing before, during and after the intervention

    Time frame: Baseline, during the intervention and at 3 months

    4 items related to psychological and physical wellbeing

  15. Repeated short measure of wellbeing

    Time frame: Baseline, during the intervention and at 3 months

    4 items related to psychological and physical wellbeing

  16. Satisfaction with social relationships

    Time frame: Baseline, 3 months

    Items on social relationships and social activity

  17. Number and time spent on outdoor activities

    Time frame: 3 months from baseline

    Number of outdoor activities and time spent there during the intervention

Other outcomes

  1. Group participants' opinions

    Time frame: during the group and at 3 months

    Group participants' opinions about the group activities and its impact on loneliness and social relationships

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • Barcelona Institute of Global Health
  • Helsinki City Older People's Services
  • The Finnish Association for the Welfare of Older People

Registry information

Official study title

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

Acronym: RECETAS

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 19, 2022
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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