LonelinessHALONCT04301167
Loneliness and Health: The Moderating Role of Befriending Services
A study testing befriending in people with Loneliness, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness
- What is being tested?
- befriending
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteIreland
- Study dates
- 1 Sep 2018to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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?")
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Trinity College Dublin
Dublin, D2
Joanna McHugh Power, PhD, 0879615036, mchughje@tcd.ie
Caoimhe Hannigan, PhD, hannigc@tcd.ie
About this study
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.
Read the 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.
- Conditions
- Loneliness
- Being tested
- befriending
- Keywords
- brain health, loneliness, aging, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
befriendingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: befriending |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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
Lubben social network scale (6 item version) - this is a scale which is well validated to be used in older populations and measures social support. Six items ask questions about social support from different sources and scores for each item range from 0-5. The total summed score ranges from a minimum value of 0 (lowest level of social support) to 30 (maximum level of social support).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Sep 2018
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- AB single-case experimental design
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Belfast, Newcastle University, University of Limerick, St. James's Hospital, Ireland
- Responsible party
- Principal investigator, Joanna McHugh, University of Dublin, Trinity College
- Investigators
- Joanna McHugh Power, PhD, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301167
- Sponsor's protocol ID
- APA2017004
- Acronym
- HALO
- Status last verified
- Mar 2020
- First submitted
- 25 Feb 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35187395
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loneliness and Health: The Moderating Role of Befriending Services
- ClinicalTrials.gov ID
- NCT04301167
- Acronym / sponsor ID
- HALO / APA2017004
- Conditions
- Loneliness
- Keywords
- brain health, loneliness, aging, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Queen's University, Belfast, Newcastle University, University of Limerick, St. James's Hospital, Ireland
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- AB single-case experimental design
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Behavioral: befriendingAn 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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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?")
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| befriendingParticipants 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. | Behavioural | Single group |
Primary outcome
Changes in Loneliness
Time frame: 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.
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.
Change in Health-related quality of life
Time frame: 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.
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).
Changes in Semantic memory
Time frame: Measured from baseline (point of study registration) and again every two weeks for max. 13 time-points (i.e. 26 weeks in total).
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.
1 secondary outcome
Changes in Social support
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 35187395Hannigan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna McHugh Power, PhD principal investigator
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing befriending in people with Loneliness, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanna McHugh Power, PhD (7065568, Joanna.McHughPower@mu.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Loneliness (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04301167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.