Clinical trial NCT04336553: Social Prescribing in Sweden (SPiS)
Official title: Social Prescribing in Sweden (SPiS)- An Interventional Research Project Evaluating a Swedish Model
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Loneliness
Keywords: Loneliness
Older adults
Social occupations
Participation
Social prescribing
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Forte
First posted: 2020-04-07
Enrollment: 220
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Loneliness among older adults has become an issue of public concern, as it is associated with increased morbidity and mortality. Yet, despite the urgency, there is little information on how to reduce or prevent loneliness. The focus of this project is using experiences from the United Kingdom's initiative social prescribing, which gives General Practitioners the option of referring clients in need to a coordinator, who in dialogue with the client finds activities for the client to engage in within the local community. Until now, social prescribing has not been tested in Sweden. Therefore, with the overarching goal of reducing loneliness and improving health and wellbeing, the aim of the project is to develop and test a Swedish social prescribing program in order to explore circumstances under which the program can reduce loneliness and improve wellbeing in older adults. The project will be carried out in collaboration between researchers, a primary healthcare center, and a community activity initiative. In the first phase, the research group will bring potential end-users and stakeholders together in workshops to discuss, develop, and design a Swedish program for social prescribing. Interviews with potential end-users and stakeholders will be carried out to analyze challenges and possibilities with the program. In a second phase, the Swedish program will be implemented to evaluate experiences and the effect of Social prescribing in Sweden regarding loneliness, health, wellbeing among older adults (65 yrs or older) in Sweden. The study will be carried out in a feasibility study and a large-scale RCT study. including both qualitative and quantitative data Based on the results of this study, there will be new knowledge gained concerning if and how social prescribing can be used among older adults in a Swedish context.

Detailed description: Loneliness among older adults has become an issue of public concern. There seems to be a high and stable prevalence of reported loneliness, with as many as 50% of older adults reporting serious or moderate loneliness. There is also growing evidence on the significant harmful effects of loneliness in older adults . Although the situation is urgent, no specific type of intervention has demonstrated a robust evidence base for reducing loneliness. There are, however, promising initiatives that manage to take the wider context in which the individual lives into account. Initiatives such as Social Prescribing in the United Kingdom identify the individual's needs, and guide them in getting involved with their community, by linking people with local supportive social activities and opportunities. However, such initiatives are sensitive to context, and may not be easily transferred between national contexts. The focus of this project is to develop and implement Social Prescribing in a Swedish context, as this has not yet been done. Our novel contribution to this field is: a) developing a Swedish version of a social prescribing method together with potential end-users and stakeholders; and b) evaluating the first test and implementation of this method. Thus, this project has the potential to develop important knowledge regarding how to prevent and/or reduce an urgent public health issue, loneliness among older adults, in a non-medical way via social prescribing in a Swedish context.

Background and point of departure

Systematic reviews show that social isolation and loneliness among older people is a substantial problem (affecting 7-17% and 40% respectively), and that lack of social inclusion and a feeling of loneliness negatively affects physical and mental health. These issues are especially prevalent in older people with health problems, and are associated with socio-demographic factors (gender) and social factors (e.g., civil status and meaningful social contacts). The research findings call for attention to be given to the provision of services for meeting societal ideals in caring for the older generation, confronting the rising isolation and subjective loneliness which harms individual health and burdens national and global economies.

There might though be protective factors addressing loneliness as research demonstrates the importance of social relations and social engagement in older people's health, well-being, and cognitive health. Strong mortality effects also exist,148 longitudinal studies revealed a 50% mortality reduction in persons with strong social relationships.

Societal services need to be developed that prevent loneliness and support social participation. A social equivalent to the physical activity on prescription is the United Kingdom initiative started in 2002 called social prescribing, which serves as a way of linking patients in primary care with sources of support within their local community. Social prescribing concerns expanding the options available to General Practitioners (GP) by allowing them to forward a client with psychosocial issues to existing meaningful activities in the community that meet these needs. There are no set standards in the procedures of social prescribing, but it gives a GP the option of using a non-medical referral, either as a stand-alone, or together with existing treatments. The sources of support in the community can be either in the volunteer or community sectors. Challenges that have been described include the multiplicity of options and the logistical difficulties although the idea is simple, the implementation is complex. What is essential is that there is a direct referral from primary care, and an identified coordinator who connects the person to local activities that meet their needs and aspirations.

Although no robust evidence, findings report that social prescribing is broadly supportive to reducing demand on primary and secondary care, and has the potential to deliver cost savings, improvements in wellbeing, reduction of mental and physical symptoms, as well as a reduction in social isolation and loneliness. There is, in particular, a need to highlight research questions such as; When, for whom, and how well does social prescribing work, and in addition, what effect does it have?

Social prescribing has not yet been tested in a Swedish context. There are reasons to believe that perceptions will differ somewhat between the two countries, partly as a consequence of their different ways of understanding relations between the citizen and the "proper" provider of healthcare. With a high number of older adults reporting loneliness, and knowing the harmful effects of this situation, initiatives need to be taken. Social prescribing developed and implemented into a Swedish context is such an initiative.

In the first phase, the researchers will develop and design a social prescribing intervention for a Swedish context (SPiS) and in the second phase, the theory will then be tested while the intervention is implemented in a regular primary healthcare center to assess how the program works. Finally, in a third phase, the program theory will be refined based on the prior developed knowledge.

Co-creation together with a feasibility study and a randomized controlled trial will be used in order to understand and reflect design and development of program for social prescribing.

Both quantitative as well as qualitative data will be collected using different methods. In order to understand feasibility and reach power in the statistics, the program will be implemented in at least eight different primary care centers around Sweden. Randomly older adults will be selected to either get Social prescribing within four working days (intervention group) or be on a waiting list (control group) for three months.

Individual interviews

Group interviews will be performed with representatives from our collaborating partners; a) the health care center, b) the involved community-based activity initiative, and c) local and societal representatives for older adults (65 years old or older) in order to gain knowledge about factors important to address loneliness, health and well-being. Questions about the theoretical underpinnings of the model, the practical implementation of the model in the regular day to day practice as well as the fidelity to the prescription will be important topics to address. Social prescribing per se and its potential effective mechanisms, moderating factors, as well as barriers in the procedure will also be discussed with the profession and stakeholders.

In addition, qualitative interviews will be conducted with the participants who have received social prescribing as well as the professionals who deliver the intervention.

Quantitative measures

Quantitative demographic data of the participants (older adults receiving the SPiS), age, gender, education level, diagnosis affecting activity performance and interests, will be collected at baseline and follow-up followed by measurement of loneliness, self-rated health, mapping of social networks and social support.

Data analysis

The quantitative data will generate evidence regarding the expected outcomes of loneliness, health and activity engagement to address the issue of for whom, under which circumstances, and in what respect the intervention is working. Descriptive statistics, as well as parametric and non-parametric statistical analysis will be used to detect changes between groups of older adults in the outcome variables.

Evidence generated through the qualitative work focusing particularly on contextual factors and potential mechanisms will address the issue of what in the intervention is working and why. Data will be analyzed thematically, with grounded theory approaches and/or other relevant qualitative measures.

Eligibility criteria: Inclusion Criteria:

- Persons 65 years or older who experience loneliness will be included after given informed consent

Exclusion Criteria:

- Persons who, due to cognitive impairment, are unable to give informed consent will be excluded

Primary outcomes:
measure: Loneliness
timeFrame: 0, 3 and 12 month
Secondary outcomes:
measure: Health
timeFrame: 0, 3 and 12 months
measure: Health
timeFrame: 0, 3 and 12 months
measure: Depression
timeFrame: 0, 3 and 12 months
measure: MNPS Interest checklist
timeFrame: 0, 3 and 12 months
measure: Social network and support
timeFrame: 0, 3 and 12 months
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Hälsocentralen Husläkarna
Study officials:
affiliation: Umeå University
name: Ingeborg Nilsson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nyqvist F, Cattan M, Conradsson M, Nasman M, Gustafsson Y. Prevalence of loneliness over ten years among the oldest old. Scand J Public Health. 2017 Jun;45(4):411-418. doi: 10.1177/1403494817697511. Epub 2017 Apr 6.
citation: Holt-Lunstad J, Smith TB, Baker M, Harris T, Stephenson D. Loneliness and social isolation as risk factors for mortality: a meta-analytic review. Perspect Psychol Sci. 2015 Mar;10(2):227-37. doi: 10.1177/1745691614568352.
citation: Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316.
citation: Mann F, Bone JK, Lloyd-Evans B, Frerichs J, Pinfold V, Ma R, Wang J, Johnson S. A life less lonely: the state of the art in interventions to reduce loneliness in people with mental health problems. Soc Psychiatry Psychiatr Epidemiol. 2017 Jun;52(6):627-638. doi: 10.1007/s00127-017-1392-y. Epub 2017 May 20.
citation: Masi CM, Chen HY, Hawkley LC, Cacioppo JT. A meta-analysis of interventions to reduce loneliness. Pers Soc Psychol Rev. 2011 Aug;15(3):219-66. doi: 10.1177/1088868310377394. Epub 2010 Aug 17.
citation: Social prescribing: community-based referral in public health. Perspect Public Health. 2018 Jan;138(1):18-19. doi: 10.1177/1757913917736661. No abstract available.
citation: Dickens AP, Richards SH, Greaves CJ, Campbell JL. Interventions targeting social isolation in older people: a systematic review. BMC Public Health. 2011 Aug 15;11:647. doi: 10.1186/1471-2458-11-647.
citation: Dahlberg L, Andersson L, McKee KJ, Lennartsson C. Predictors of loneliness among older women and men in Sweden: A national longitudinal study. Aging Ment Health. 2015;19(5):409-17. doi: 10.1080/13607863.2014.944091. Epub 2014 Aug 15.
citation: World Health Organization. Knowledge translation on ageing & health: A framework policy development 2012. Geneva, Switzerland.: WHO Document Production Services 2012.
citation: Ferlander S. The importance of different forms of social capital for health. Acta Sociologica. 2007;50(2):115-28.
citation: Thomson LJ, Camic PM, Chatterjee HJ. Social prescribing: A review of community referral schemes. London: University College London: University College London; 2015
citation: Brandling J, House W. Social prescribing in general practice: adding meaning to medicine. Br J Gen Pract. 2009 Jun;59(563):454-6. doi: 10.3399/bjgp09X421085. No abstract available.
citation: Bickerdike L, Booth A, Wilson PM, Farley K, Wright K. Social prescribing: less rhetoric and more reality. A systematic review of the evidence. BMJ Open. 2017 Apr 7;7(4):e013384. doi: 10.1136/bmjopen-2016-013384.
citation: Wilson P, Booth A. Evidence to inform the commissioning of social presribing. York: University of York. Center of Reviews and Dissemination; 2015.
citation: Kimberlee RH. Developing a social prescribing approach for Bristol. Bristol: University of the West of England; 2013.
citation: Polley M, Bertotti B, Kimberlee R, Pilkington K, Refsum C. A review of the evidence assessing impact of social prescribing on healthcare demand and cost implications. University of Westminister; 2017.
citation: Lindberg J, Lundgren A-S. Positioning the ageing subject: Articulations of choice in Sweden and UK health and social care. Policy studies. 2019:doi.org/10.1080/01442872.2019.1599839.
citation: Nilsson I, Nyqvist F, Gustafson Y, Nygard M. Leisure Engagement: Medical Conditions, Mobility Difficulties, and Activity Limitations-A Later Life Perspective. J Aging Res. 2015;2015:610154. doi: 10.1155/2015/610154. Epub 2015 Aug 5.