Clinical trial NCT04301167: Loneliness and Health: The Moderating Role of Befriending Services
Official title: Loneliness and Health: The Moderating Role of Befriending Services
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Loneliness
Keywords: brain health
loneliness
aging
quality of life
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Queen's University, Belfast
name: Newcastle University
name: University of Limerick
name: St. James's Hospital, Ireland
First posted: 2020-03-10
Enrollment: 85
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: AB single-case experimental design
Primary purpose: PREVENTION

Brief summary: Befriending services deliver companionship to older adults through regular volunteer visits. ALONE is a charitable organisation providing befriending services to older adults in Ireland. It is the mission statement of ALONE to use befriending to reduce the negative impact loneliness has on health, but evidence for this use of befriending is yet to be sufficiently provided. Providing such evidence would help organisations like ALONE to convince policymakers of the need for, and importance of, their services. The research uses a rigorous scientific approach to evaluate the effect of befriending services on health. Two domains of health thought to be particularly important for ageing adults are evaluated: health-related quality of life (HrQoL), and cognitive function. Maximising HrQoL should be a goal of any healthcare intervention, while cognitive function is associated with dementia risk, a major factor threatening independence in later life. The research is also investigating whether befriending can reduce the negative effect that loneliness is known to have on health of older adults. Service users, befriending volunteers, and professionals involved with the service, will be interviewed by researchers, to see if there are other ways that befriending might improve health. An economic analysis of the service, to evaluate its cost, is also planned. Findings will then be translated all findings into befriending service recommendations for the Department of Health.

To conduct this research, 85 new befriending service users are needed. 10-15 pairs of befriender-befriendees will also be interviewed, and 5-10 health and social care professionals involved with the service. Expected outcomes are to provide ALONE with scientific evidence related to the effects of befriending services on health, and to influence policymakers by clarifying the extent of the economic and health benefits of befriending services.

Detailed description: Background: Loneliness is related to poor health in later life. One way in which loneliness is often addressed is via befriending services, such as those offered by ALONE. The mission statement of ALONE's befriending service is to reduce the impact of loneliness on poor health. ALONE have identified a need for an empirical evaluation of the potential benefits of befriending services. Aims: The proposed research aims to create empirical evidence regarding the impact of befriending services on health and loneliness, assisting ALONE in developing and refining their mission statement. The research question is: "Do befriending services improve health (measured as health-related quality of life and cognitive function), and do they mitigate the impact of loneliness on health?" A secondary aim is to identify, using exploratory methods, potential mechanisms through which befriending impacts health.

Plan of Investigation: A mixed methods design, integrating qualitative and quantitative methods, is planned.

The quantitative component comprises an AB single-case experimental multiple baseline design, analysed using generalised additive modelling, and the qualitative component comprises semi-structured interviews (with befriender-befriendee dyads and healthcare professionals associated with the service) designed and analysed according to the principles of grounded theory. Results will be integrated according to mixed methods guidelines, undergo triangulation, and an economic analysis will evaluate the cost should the service be rolled out nationally. All results will be integrated to form the basis of recommendations for the befriending sector, to be disseminated to policymakers. Results will also be disseminated via peer-reviewed publication and lay report.

Potential Impact: The study has potential to improve the service offered by ALONE by empirically testing its effectiveness and mechanisms of action, influence policy with this information, and contribute to theoretical understanding of the nature of the relationship between befriending, loneliness, and health.

Eligibility criteria: Inclusion Criteria:

* being interested in becoming an ALONE befriending service user
* being aged over 60
* having ability to provide informed consent
* having sufficient sensory ability to engage in an interview (if engaging in qualitative component of study)
* self-report of loneliness (responds yes to the question "do you sometimes feel lonely?")

Exclusion Criteria:

* self-report of receipt of a diagnosis by a doctor of any of the following: intellectual disability including autism spectrum disorder or psychotic disorder, dementia, or serious memory impairment
* Living outside the greater Dublin area

Primary outcomes:
measure: Changes in Loneliness
timeFrame: Measured from baseline (point of study registration) and again every two weeks for max. 13 time-points (i.e. 26 weeks in total). At each point of testing, participants are asked to reflect on their loneliness at that point in time.
measure: Change in Health-related quality of life
timeFrame: Measured from baseline (point of study registration) and again every two weeks for max. 13 time-points (i.e. 26 weeks in total). At each point of testing, participants are asked to reflect on their health-related quality of life at that point in time.
measure: Changes in Semantic memory
timeFrame: Measured from baseline (point of study registration) and again every two weeks for max. 13 time-points (i.e. 26 weeks in total).
Secondary outcomes:
measure: Changes in Social support
timeFrame: Measured from baseline (point of study registration) and again every two weeks for max. 13 time-points (i.e. 26 weeks in total). At each point of testing, participants are asked to reflect on their social support at that point in time.
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Trinity College Dublin
Study officials:
affiliation: University of Dublin, Trinity College
name: Joanna McHugh Power, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hannigan C, Hanly P, Kee F, Lawlor B, Holton E, Walsh C, Scharf T, Coen R, Leatham V, Moynihan S, Lane K, McHugh Power J. HALO: Study protocol for a single-case experimental design study evaluating the moderating impact of a befriending intervention on the association between loneliness and health in older adults. HRB Open Res. 2022 Jan 31;3:60. doi: 10.12688/hrbopenres.13104.2. eCollection 2020.