Clinical trial NCT05507684: Effects of Nature-based Group Intervention on Quality-of-life in Lonely Older People Living in Assisted Living Facities
Official title: RECETAS (Re-Imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) in Helsinki
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Loneliness
Keywords: Loneliness, nature activities, group intervention, socialization
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Barcelona Institute of Global Health
name: Helsinki City Older People's Services
name: The Finnish Association for the Welfare of Older People
First posted: 2022-08-19
Enrollment: 316
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in health related quality of life
timeFrame: From baseline to 3months, 6months, 12 months
measure: Change in loneliness
timeFrame: From baseline to 3months, 6months, 12 months
Secondary outcomes:
measure: Change in Psychological Wellbeing
timeFrame: From baseline to 3months, 6months, 12 months
measure: Change in executive function
timeFrame: From baseline to 3months, 6months, 12 months
measure: Change in cognition
timeFrame: From baseline to 3months, 6months, 12 months
measure: Minimental State Examination
timeFrame: Only baseline
measure: Change in self Efficacy
timeFrame: From baseline to 3months
measure: Change in frailty phenotype
timeFrame: Only baseline
measure: Change in blood pressure
timeFrame: From baseline to 3months and 12 months
measure: Change in sleep quality
timeFrame: From baseline to 3months, 6months, 12 months
measure: Change in attachment to neighbourhood
timeFrame: From baseline to 3months
measure: Change in relationship with nature
timeFrame: From baseline to 3months
measure: Use of health and social services
timeFrame: during 12 months from baseline
measure: Health economic analyses (costs of health services with EQ5D-5L)
timeFrame: During 12 months (3mo, 6mo, 12mo)
measure: Change in social relationships
timeFrame: From baseline to 3months, 6months, 12 months
measure: Repeated wellbeing before, during and after the intervention
timeFrame: Baseline, during the intervention and at 3 months
measure: Repeated short measure of wellbeing
timeFrame: Baseline, during the intervention and at 3 months
measure: Satisfaction with social relationships
timeFrame: Baseline, 3 months
measure: Number and time spent on outdoor activities
timeFrame: 3 months from baseline
Other outcomes:
measure: Group participants' opinions
timeFrame: during the group and at 3 months
Locations:
city: Helsinki
country: Finland
facility: Helsinki City assisted living facilities
Study officials:
affiliation: Barcelona Institute for Global Health
name: Jill S Litt, PhD
role: PRINCIPAL_INVESTIGATOR
References: