Social IsolationSILNCT05998343
Intergenerational Program for Social Isolation and Loneliness in Older Adults Discharged From the Emergency Department
A study testing Intergenerational HOW R U? and Same-Generation Peer Support HOW R U? in people with Social Isolation and Loneliness, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Social isolation and loneliness worsens older adults' risk of dementia, quality of life, and death as much as smoking. Older adults are more likely to use emergency services and are also more likely to experience social isolation and loneliness than younger people. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Isolation, Loneliness, Geriatric
- What is being tested?
- Intergenerational HOW R U? and Same-Generation Peer Support HOW R U?
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2021to 1 Feb 2024
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Any community-dwelling person 70 years of age and older receiving care from the ED, Family Medicine, or Geriatric clinics at the two participating sites (MSH and NYGH) will be eligible.
- Baseline de Jong loneliness scores of 2.0 will be required for participation in the trial.
Who cannot join
- Age less than 70 years;
- Patients with communication problems (critically ill, unconscious, language barrier, speech impairment or otherwise unable to provide consent), or admission to a hospital for > 72 hours.
- Patients with severe cognitive impairment or those living in nursing homes who are dependent on others for their activity of daily living will be excluded.
- Patients without any mobile phone or landline.
- Volunteers:
- Volunteers will be 60 years of age or older to qualify as peer-support volunteers.
- Volunteers will be 19-39 years of age to qualify as intergenerational volunteers.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1XS
Jacques Lee, MD, Jacques.lee@sinaihealth.ca
About this study
Official title: Improving Social Isolation and Loneliness in Older Adults Discharged From the Emergency Department - Comparing an Intergenerational Versus Same Generation Peer-support Intervention Versus Common Wait List Control Group in a Three Arm RCT
Social isolation and loneliness worsens older adults' risk of dementia, quality of life, and death as much as smoking. Older adults are more likely to use emergency services and are also more likely to experience social isolation and loneliness than younger people. The emergency department is a new setting to screen for social isolation and loneliness in older adults and help accordingly.
Social isolation and loneliness are experienced differently by different older adults. Different interventions combatting social isolation and loneliness may work better for different people, and little is known about older adult's preferences for specific types of interventions.
Read more
HOW R U? is an effective and feasible intervention using same-generation peer support offered by trained hospital volunteers to reduce social isolation and loneliness in older adults. In partnership with the Australian developer of HOW R U?, this study will compare an intergenerational HOW R U? intervention using younger volunteers with the same-generation peer support intervention and a waitlist control arm.
The investigators partnered with the staff of emergency departments and family medicine clinics to identify people who will benefit from an intervention combatting, and Volunteer Services to recruit volunteers.
The investigators hypothesize that the older adults who receive the intergenerational HOW R U? intervention will have a greater improvement in social isolation and loneliness.
Read the detailed description
Introduction:
Social isolation and loneliness (SIL) worsens mortality and other outcomes among older adults as much as smoking. The investigators previously tested the impact of the HOW R U? intervention using peer support from similar aged volunteers and demonstrated reduced SIL among older adults discharged from the Emergency Department (ED). Generativity, defined as "the interest in establishing and guiding the next generation" can provide an alternative theoretical basis for reducing SIL via intergenerational programs between members of younger and older generations. The current study will examine the impact of younger intergenerational volunteers providing the HOW R U? intervention. As part of a program of research following the Obesity-Related Behavioral Intervention Trials (ORBIT ) model, findings of this RCT will be used to define which intervention characteristics are most effective in reducing SIL. This trial builds on feasibility work conducted in the investigators' previous trial (NCT 05228782).
Methods and Analysis:
The investigators will compare the use of the same-generation peer support HOW RU? intervention to support by intergenerational volunteers. The investigators will use a common wait list control group in this three-arm randomized controlled trial (RCT).
Trained volunteers will deliver 12 weekly telephone support calls. The investigators will recruit 141 participants ≥70 years of age with baseline loneliness (six-item De Jong loneliness score of 2 or greater) from two EDs. Research staff will assess change in loneliness (De Jong Loneliness Scale), social isolation (Lubben's Social Network Scale), depression (Geriatric Depression Score), quality of life (EQ-5D-5L), functional status (Older Americans Resource Scale), generativity (Loyola Generativity Scale), and perceived benefit at baseline (subjective Likert scale), at 12-14 weeks, and 24-26 weeks post-intervention. The study will follow the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.
Ethics and Dissemination:
The participating research ethics boards have granted ethics approval, and the participants randomized to the waitlist control group will be offered their choice of intergenerational or same-generation HOW R U? interventions after 12 weeks. Results will be shared through journal publications, conference presentations, social media, and through the International Federation of Emergency Medicine.
- Conditions
- Social Isolation, Loneliness, Geriatric
- Being tested
- Intergenerational HOW R U?, Same-Generation Peer Support HOW R U?
- Keywords
- Loneliness, Social Isolation, Emergency Department, Geriatrics, Geriatric Psychiatry, Family Medicine, Randomized Clinical Trial
- Medical subject headings
- Social Isolation, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intergenerational HOW R U?Behavioural
1-on-1 discussion over telephone with a trained volunteer aged 19-39 years old who has received training to provide strength-based support sessions weekly for 12 weeks.
Same-Generation Peer Support HOW R U?Behavioural
1-on-1 discussion over telephone with a trained volunteer aged 60 years or older who has received training to provide strength-based support sessions weekly for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HOW R U? intervention delivered by same-generation peer volunteer | Experimental | HOW R U? Receives: Behavioral: Same-Generation Peer Support HOW R U? |
| HOW R U? intervention delivered by intergenerational volunteer | Experimental | Not described Receives: Behavioral: Intergenerational HOW R U? |
| Waitlist control group | No intervention | After the primary outcome assessment at 12 weeks, control group participants will be offered HOW R U? intervention support outside of the main trial. They will be allowed to choose either intergenerational or same-generation versions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in loneliness using De Jong Gierveld 6-item Loneliness Scale from Baseline to 12 Weeks
The minimum value is 0 and the maximum value is 6, with the higher value corresponding with a greater degree of loneliness. It is divided into 4 clinically relevant categories: 0-1 = no loneliness, 2-3 = low levels of loneliness, 4-5 = moderate to severe loneliness, and 6 = severe loneliness.
Measured: Measure at baseline, at 12 weeks (primary outcome) and 24 weeks (sustainability)
Secondary outcomes (7)
Change in perceived social support using Lubben Social Network Scale
The Lubben Social Network Scale is a measure of perceived social support received from the family and friends and consists of 6 items each of which is scored from 0 to 5: none = 0, one = 1, two = 2, three or four = 3, five through eight = 4, nine or more = 5. The total score ranges from 0 to 30, and a score of 12 and lower indicates a status of "at-risk" for social isolation
Measured: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Change in mood using Geriatric Depression Scale
The Geriatric Depression Scale is a 15-item scale of mood that is extensively validated in older populations to screen for depression. Scores range from 0 to 15. A score of 0-4 is considered normal, and a score of 5 or higher is considered indicative of depression with higher scores indicating higher severity of depression.
Measured: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Change in Quality of Life using Euro-Qual 5 Dimensions 5 Levels
EQ-5D-5Lin 5 dimensions. In each dimension, quality of life can be measured from 1 (best quality of life) to 5 (worst quality of life), giving a possible score of 5-25. A higher score indicates worse quality of life. (Euro-Qual 5 Dimensions 5 Levels) scale assesses quality of life
Measured: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Change in Functional Status using Older Americans Resource Scale
The Older Americans Resource Scale (OARS) consists of 7 activities of daily living (ADL) questions and 7 instrumental activities of daily living (IADL) all rated as "without any help" (2 points), "with some help" (1 point), or "completely unable" (0 points). The ADL and IADL scores can be used separately or combined to produce an overall OARS score from 0-28.
Measured: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Change in self-perceptions of generativity using Loyola Generativity Scale
The Loyola Generativity Scale is a 20-item scale with each question answered 0 = statement never applies to you, 1 = statement only occasionally or seldom applies to you, 2 = statement applies to you fairly often, or 3 = statement applies to you very often or nearly always.
The higher the score, the greater the sense of generativity.
Measured: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Perceived benefit to participant at 12 weeks
Perceived benefit by the participant pre- and post-intervention will be assessed using the question "Compared to working with a volunteer around the same age as you, you think that working with a younger volunteer is:" followed by a 5-point Likert scale with the following options: A lot less helpful for me, a little less helpful for me, about the same for me, a little more helpful for me, or a lot more helpful for me.
Measured: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Perceived benefit to volunteer at 12 weeks
Perceived benefit by the participant for the volunteer pre- and post-intervention will be assessed using the question "Compared to working with a volunteer around the same age as you, you think that working with a younger volunteer is:" followed by a 5-point Likert scale with the following options: A lot less helpful for the volunteer, a little less helpful for the volunteer, about the same for the volunteer, a little more helpful for the volunteer, or a lot more helpful for volunteer.
Measured: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Nov 2021
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Feb 2024 (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 Social IsolationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a three-arm outcome assessor blinded randomized controlled trial will follow SPIRIT reporting guidelines and is part of a program of research that adheres to the ORBIT model for developing complex behavioural interventions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- North York General Hospital, Sunnybrook Research Institute, University of Toronto, Bolton Clarke Research Institute, King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998343
- Sponsor's protocol ID
- 21-0074-E
- Acronym
- SIL
- Status last verified
- Jul 2023
- First submitted
- 24 Jul 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified individual level data that support the findings of this study will be available on reasonable request from the Principal Investigator Dr. Jacques Lee (Jacques.lee@sinaihealth.ca) to improve scientific transparency, verify the study findings and generating new knowledge. As this research was supported by public funding, request for commercial purposes will require approval of the funding agency.
Publications
Zheng D, Rose L, Borgundvaag B, McLeod SL, Melady D, Mohindra R, Sinha S, Wesson V, Wiesenfeld L, Kolker S, Kiss A, Lowthian JA, Lee JS. Impact of an intergenerational program to improve loneliness and social isolation in older adults initiated at the time of emergency department discharge: study protocol for a three-arm randomized clinical trial. Trials. 2024 Jun 28;25(1):425. doi: 10.1186/s13063-024-08250-2.
PubMed 38943176
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Social Isolation and Loneliness in Older Adults Discharged From the Emergency Department - Comparing an Intergenerational Versus Same Generation Peer-support Intervention Versus Common Wait List Control Group in a Three Arm RCT
- ClinicalTrials.gov ID
- NCT05998343
- Acronym / sponsor ID
- SIL / 21-0074-E
- Conditions
- Social Isolation, Loneliness, Geriatric
- Keywords
- Loneliness, Social Isolation, Emergency Department, Geriatrics, Geriatric Psychiatry, Family Medicine, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- North York General Hospital, Sunnybrook Research Institute, University of Toronto, Bolton Clarke Research Institute, King's College London
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 18 Aug 2023 (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.
Social isolation and loneliness worsens older adults' risk of dementia, quality of life, and death as much as smoking. Older adults are more likely to use emergency services and are also more likely to experience social isolation and loneliness than younger people. The emergency department is a new setting to screen for social isolation and loneliness in older adults and help accordingly.
Social isolation and loneliness are experienced differently by different older adults. Different interventions combatting social isolation and loneliness may work better for different people, and little is known about older adult's preferences for specific types of interventions.
HOW R U? is an effective and feasible intervention using same-generation peer support offered by trained hospital volunteers to reduce social isolation and loneliness in older adults. In partnership with the Australian developer of HOW R U?, this study will compare an intergenerational HOW R U? intervention using younger volunteers with the same-generation peer support intervention and a waitlist control arm.
The investigators partnered with the staff of emergency departments and family medicine clinics to identify people who will benefit from an intervention combatting, and Volunteer Services to recruit volunteers.
The investigators hypothesize that the older adults who receive the intergenerational HOW R U? intervention will have a greater improvement in social isolation and loneliness.
Detailed description
Introduction:
Social isolation and loneliness (SIL) worsens mortality and other outcomes among older adults as much as smoking. The investigators previously tested the impact of the HOW R U? intervention using peer support from similar aged volunteers and demonstrated reduced SIL among older adults discharged from the Emergency Department (ED). Generativity, defined as "the interest in establishing and guiding the next generation" can provide an alternative theoretical basis for reducing SIL via intergenerational programs between members of younger and older generations. The current study will examine the impact of younger intergenerational volunteers providing the HOW R U? intervention. As part of a program of research following the Obesity-Related Behavioral Intervention Trials (ORBIT ) model, findings of this RCT will be used to define which intervention characteristics are most effective in reducing SIL. This trial builds on feasibility work conducted in the investigators' previous trial (NCT 05228782).
Methods and Analysis:
The investigators will compare the use of the same-generation peer support HOW RU? intervention to support by intergenerational volunteers. The investigators will use a common wait list control group in this three-arm randomized controlled trial (RCT).
Trained volunteers will deliver 12 weekly telephone support calls. The investigators will recruit 141 participants ≥70 years of age with baseline loneliness (six-item De Jong loneliness score of 2 or greater) from two EDs. Research staff will assess change in loneliness (De Jong Loneliness Scale), social isolation (Lubben's Social Network Scale), depression (Geriatric Depression Score), quality of life (EQ-5D-5L), functional status (Older Americans Resource Scale), generativity (Loyola Generativity Scale), and perceived benefit at baseline (subjective Likert scale), at 12-14 weeks, and 24-26 weeks post-intervention. The study will follow the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.
Ethics and Dissemination:
The participating research ethics boards have granted ethics approval, and the participants randomized to the waitlist control group will be offered their choice of intergenerational or same-generation HOW R U? interventions after 12 weeks. Results will be shared through journal publications, conference presentations, social media, and through the International Federation of Emergency Medicine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study is a three-arm outcome assessor blinded randomized controlled trial will follow SPIRIT reporting guidelines and is part of a program of research that adheres to the ORBIT model for developing complex behavioural interventions.
| Arm | Type | Receives |
|---|---|---|
| HOW R U? intervention delivered by same-generation peer volunteer | Experimental | Behavioral: Same-Generation Peer Support HOW R U?HOW R U? |
| HOW R U? intervention delivered by intergenerational volunteer | Experimental | Behavioral: Intergenerational HOW R U? |
| Waitlist control group | No intervention | –After the primary outcome assessment at 12 weeks, control group participants will be offered HOW R U? intervention support outside of the main trial. They will be allowed to choose either intergenerational or same-generation versions. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Any community-dwelling person 70 years of age and older receiving care from the ED, Family Medicine, or Geriatric clinics at the two participating sites (MSH and NYGH) will be eligible.
- Baseline de Jong loneliness scores of 2.0 will be required for participation in the trial.
Key exclusion criteria (7 listed)
- Age less than 70 years;
- Patients with communication problems (critically ill, unconscious, language barrier, speech impairment or otherwise unable to provide consent), or admission to a hospital for > 72 hours.
- Patients with severe cognitive impairment or those living in nursing homes who are dependent on others for their activity of daily living will be excluded.
- Patients without any mobile phone or landline.
- Volunteers will be 60 years of age or older to qualify as peer-support volunteers.
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 |
|---|---|---|
| Intergenerational HOW R U?1-on-1 discussion over telephone with a trained volunteer aged 19-39 years old who has received training to provide strength-based support sessions weekly for 12 weeks. | Behavioural | HOW R U? intervention delivered by intergenerational volunteer |
| Same-Generation Peer Support HOW R U?1-on-1 discussion over telephone with a trained volunteer aged 60 years or older who has received training to provide strength-based support sessions weekly for 12 weeks. | Behavioural | HOW R U? intervention delivered by same-generation peer volunteer |
Primary outcome
Change in loneliness using De Jong Gierveld 6-item Loneliness Scale from Baseline to 12 Weeks
Time frame: Measure at baseline, at 12 weeks (primary outcome) and 24 weeks (sustainability)
The minimum value is 0 and the maximum value is 6, with the higher value corresponding with a greater degree of loneliness. It is divided into 4 clinically relevant categories: 0-1 = no loneliness, 2-3 = low levels of loneliness, 4-5 = moderate to severe loneliness, and 6 = severe loneliness.
7 secondary outcomes
Change in perceived social support using Lubben Social Network Scale
Time frame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Change in mood using Geriatric Depression Scale
Time frame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Change in Quality of Life using Euro-Qual 5 Dimensions 5 Levels
Time frame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Change in Functional Status using Older Americans Resource Scale
Time frame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Change in self-perceptions of generativity using Loyola Generativity Scale
Time frame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Perceived benefit to participant at 12 weeks
Time frame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Perceived benefit to volunteer at 12 weeks
Time frame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Derived from this study: PubMed 38943176Zheng D, Rose L, Borgundvaag B, McLeod SL, Melady D, Mohindra R, Sinha S, Wesson V, Wiesenfeld L, Kolker S, Kiss A, Lowthian JA, Lee JS. Impact of an intergenerational program to improve loneliness and social isolation in older adults initiated at the time of emergency department discharge: study protocol for a three-arm randomized clinical trial. Trials. 2024 Jun 28;25(1):425. doi: 10.1186/s13063-024-08250-2.
- Individual participant dataSharing planned: Yes. The de-identified individual level data that support the findings of this study will be available on reasonable request from the Principal Investigator Dr. Jacques Lee (Jacques.lee@sinaihealth.ca) to improve scientific transparency, verify the study findings and generating new knowledge. As this research was supported by public funding, request for commercial purposes will require approval of the funding agency.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intergenerational HOW R U? and Same-Generation Peer Support HOW R U? in people with Social Isolation and Loneliness, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 2 inclusion and 7 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 18 Aug 2023. 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 Canada. 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 Jacques Lee, MD (4168771447, Jacques.lee@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in loneliness using De Jong Gierveld 6-item Loneliness Scale from Baseline to 12 Weeks (time frame: Measure at baseline, at 12 weeks (primary outcome) and 24 weeks (sustainability)). 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 NCT05998343, 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 18 Aug 2023.