Loneliness and Health: The Moderating Role of Befriending Services

NCT04301167 | Unknown

• 1 other identifier: APA2017004
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness

Keywords

brain health; loneliness; aging; quality of life

Outcome Measures

Primary Outcomes (3)

• Changes in Loneliness

  University of California at Los Angeles 5-item loneliness scale: This is a five item well validated scale of loneliness suitable for use in older adults. Each item yields scores between 0 and 2. Overall minimum score is 0 and overall maximum score is 10 with higher scores indicating more loneliness.

  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.

• Change in Health-related quality of life

  EuroQol 5-Dimension (3-levelL) scale. A well validated scale of health-related quality of life which measures five dimensions of health across three possible levels. Scores can be combined to a summary score which is between 0 (worst health/death) and 1 (best possible health).

  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.

• Changes in Semantic memory

  Delis Kaplan Executive Functioning System verbal fluency tests standard and alternate: these tests elicit participants' ability to name as many items belonging to a given category (animals, words beginning with F, fruits) as possible in 60 seconds. The minimum value (worst performance) is 0; there is no theoretical maximum value but higher scores indicate better performance.

  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 (1)

• Changes in Social support

  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.

Study Arms (1)

Single group

EXPERIMENTAL

An AB single-case experimental design will be used. An RCT would be inappropriate since the befriending intervention is known to improve wellbeing. As such participants will have data collected in a pre- and post-intervention phase, for a maximum of 13 time points. This approach has been identified by What Works Clearinghouse as an acceptable empirical design to include in evidence based practice reviews (Kratchowill et al., 2010).

Behavioral: befriending

Interventions

befriending BEHAVIORAL

Participants are new users of the ALONE befriending intervention, which matches participants to volunteer befrienders who visit once weekly for a minimum of 12 months. It is a criterion of study involvement that participants commit to completing at least two data collection timepoints before being matched to a befriender.

Single group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?")

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• Queen's University, Belfast: collaborator
• Newcastle University: collaborator
• University of Limerick: collaborator
• St. James's Hospital, Ireland: collaborator

Study Sites (1)

Trinity College Dublin

Dublin, D2, Ireland

RECRUITING

Related Publications (1)

• 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.

  PMID: 35187395 DERIVED

Study Officials

• Joanna McHugh Power, PhD

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanna McHugh Power, PhD

CONTACT

7065568; Joanna.McHughPower@mu.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Model Details: AB single-case experimental design

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 10, 2020
• Study Start: September 1, 2018
• Primary Completion: July 31, 2021
• Study Completion: October 31, 2021
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)