Testing a Nature-based Socila Intevention on Loneliness: the RECETAS-PRG Trial

Loneliness Clinical Trial

Official title:

Testing the Effectiveness of a Nature-based Social Intervention on Loneliness Among Lonely Adults in Prague - a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05522140
• Other study ID #: 945095 PRG
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: April 2023
• Source: Charles University, Czech Republic
• Contact: Iva Holmerová, Assoc. Prof.
• Phone: 00420602350848
• Email: iva.holmerova[@]gerontocentrum.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. Methods: A randomized controlled trial (RCT) will be used to assess the effect of NBSI on reducing feelings of loneliness. The RCT will use mixed-method approach collecting qunatitative information to assess the the main outcomes and qualitative methods to explore participant's and professional's experiences. ISGlobal coordinates the overall RECETAS project. Charles University leads the implementation of the RECETAS-PRG and is responsible for the recruitment process, intervention, assessment, evaluation, data analysis and qualitative part of the study. Recruitment will be carried out in cooperation with the Centre of Longevity and Long-Term Care, the Czech Alzheimer's Society, general practitioners and other outpatient specialists, and home care organizations based on a long-term focus on the target group. 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 arm (158 each): NBSP intervention arm and control arm. All of them will be asked to sign the informed consent form. The intervention is a theory-informed, multicomponent, multi-level, behaviorally based complex intervention that requires a specific trainning to prepare facilitators. The intervention model is adapted from the "Circle of Friends" methodology developed by the University of Helsinky by Pitkälä KH et al. It consists in: a) individualized session with facilitators (one-to-one); b) group-based program (5-15 people) for 9 sessions, one a wiil, including nature-based activities in the area chosen by the participants. Control group participants will recieve usual care, and list of natrure-based activities available ti their area.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 316
• Est. completion date: March 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Able to give informed consent in Czech

2. Aged 18 or over:

1. older adults (60+) with a risk of social isolation and loneliness or

2. family carers (18+) of home dwelling vulnerable older adults and people with dementia endangered by load of time as well as care management needed to support vulnerable older people and their caregiver or

3. dyads with/without MCI of one of these older adults (60+) living at home with a risk of social isolation and loneliness.

3. Currently experiencing loneliness according to the screening question "Do you suffer from loneliness?"

4. Willing to undergo study measurement.

Exclusion Criteria:

1. Unable to go outdoors due to poor mobility or severe diseases.

2. Poor hearing or sight in case it prevents them to participate of the group dynamics and activities in the nature.

3. Severe, moderate or mild cognitive decline.

4. Any mental health disorders that might interfere with the group dynamics.

5. Severe disease with poor prognosis < 6 months.

Related Conditions & MeSH terms

• Loneliness

Intervention

Behavioral:
• Nature-based social intervention (NBIS)
Nature-based social prescribing is a multicomponent, multi-level, behaviorally based complex intervention applaied by facilitators after a specific training. It comprises: a psychosocial component and nature-based activities. The psychosocial component is adapted from the group dynamic of "Circle of Friends" methodolgy focused on loneliness(Jansson A, Pitkälä KH, 2021) adapted to the cultural context of Prague and the target population (partitipants) of adults who lives in Prague. Participants start with an individual session and then meet once a week for two hours for 10 weeks. At the first meeting together, participants select the nature-based activities they wish to conduct through a co-created menu.
• Usual care + menu with nature based activities
Social prescribing as existing in usual care plus a written menu with the list of nature-based activities in the area.

Locations

Country	Name	City	State
Czechia	Charles University	Prag

Sponsors (2)

Lead Sponsor	Collaborator
Vladimíra Dostálová	Barcelona Institute for Global Health

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

Jansson A, Pitkala KH. Editorial: Circle of Friends, an Encouraging Intervention for Alleviating Loneliness. J Nutr Health Aging. 2021;25(6):714-715. doi: 10.1007/s12603-021-1615-5. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	De Jong Gierveld Loneliness Scale 11 item	Change in loneliness. De Jong Gierveld Loneliness Scale (minimum 0 (best) and maximum 11 (worst))	From baseline to 3months, 6months, 12 months
Primary	15D instrument of health-related quality of life	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.	From baseline to 3months, 6months, 12 months
Secondary	Psychological Wellbeing Scale by Routasalo et al. 2009	Change in psychological wellbeing.Minimum 0 (worst) and maximum 1 (best).	From baseline to 3months, 6months, 12 months
Secondary	Clock drawing test	Change in executive function. Minimum 0 (worst) and maximum 6 (best)	From baseline to 3months, 6months, 12 months
Secondary	Instrumental Activities of Daily Living Scale	Change in instrumental activities of daily living. Minimum 0 (worst) and maximum 10 (best)	From baseline to 3months, 6months, 12 months
Secondary	International Physical Activity Questionnaire	Change in physical activity. Minimum 1 (worst) and maximum 3 (best)	From baseline to 3months, 6months, 12 months
Secondary	Geriatric Depression Scale	Change in depression. Minimum 0 (best) and maximum 15 (worst)	From baseline to 3months, 6months, 12 months
Secondary	Lubben Social Network Scale	Change in social network. Minimum 0 (worst) and maximum 5 (best)	From baseline to 3months, 6months, 12 months
Secondary	EURO-QOL 5D-5L	Health economic analyses. Cost of health services with EQ5D-5L	From baseline to 3months, 6months, 12 months
Secondary	ICEpop CAPability mesure for Adults (ICECAP-A)	Self-reported measure of capability wellbeing for adults	From baseline to 3months, 6months, 12 months
Secondary	Nature connection index	Relationship with nature. Min = 1 Max = 7. Higher scores indicating stronger connectedness to nature	From baseline to 3months, 6months, 12 months

External Links

•   website of the European Projecte RECETAS