Social IsolationSILNCT05228782
COVID-19 and Social Isolation and Loneliness Trial
A study testing HOW R U? Intervention in people with Social Isolation and Loneliness, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Social isolation and loneliness worsen older peoples' quality of life, risk of dementia, and contributes to 45,000 deaths/year in Canada - as much as smoking. Isolated people use the health care system more often, but have worse outcomes. 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?
- HOW R U? Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2021to 3 Nov 2023
- 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 our two participating sites (MSH and NYGH) will be eligible.
Who cannot join
- age less than 70 years; 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. To target the intervention for older people with loneliness a baseline de Jonge loneliness scores of 2.0 will be required for participation in the trial.
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: A Phase IIb 3 Arm Randomized Clinical Pilot Study to Assess the Impact of a Peer-support Program to Improve Social Isolation and Loneliness Due to COVID-19 - Comparing the Addition of a Secure, User Friendly Video-conference Solution and Telephone Support Alone to a Waiting List Control Group
Social isolation and loneliness worsen older peoples' quality of life, risk of dementia, and contributes to 45,000 deaths/year in Canada - as much as smoking. Isolated people use the health care system more often, but have worse outcomes. Effective, inexpensive interventions exist but unfortunately they have not been implemented in Canada.
We partnered with the Australian developer of HOW R U?, an effective and feasible intervention that uses specially trained, older, hospital volunteers to provide peer support to combat isolation and loneliness in isolated older peers.
Read more
Little is known about older people's preferences for virtual care (telephone vs. video) nor their relative effectiveness. Thus we will compare two ways of delivering HOW R U: telephone support and a tested, secure user-friendly video conferencing app, aTouch Away® to a common control arm.
We also partnered with Emergency Medicine, Family Medicine, Geriatrics and Psychiatry to identify people who will benefit from peer support; and with Volunteer Services to recruit volunteers.
- Conditions
- Social Isolation, Loneliness, Geriatric
- Being tested
- HOW R U? Intervention
- 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.
HOW R U? InterventionOther
HOW RU? intervention uses trained volunteer peers to provide strength-based support sessions weekly for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HOW RU Intervention delivered by telephone | Experimental | Group Phone will receive the HOW RU? intervention over the telephone. Receives: Other: HOW R U? Intervention |
| HOW RU Intervention delivered by video-call | Experimental | Group Video will receive the HOW RU? intervention delivered over video-call using the aTouch Away platform. Receives: Other: HOW R U? Intervention |
| Wait-list Control Group | No intervention | Control groups will be offered standard care through their referring service (i.e. their routine clinical follow-up). The control group will be offered HOW RU? telephone support outside of the main trial after their primary outcome assessment at 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in De Jong Gierveld Loneliness Scale at Baseline
We will use the 6-item De Jong Gierveld loneliness scale as our primary outcome measure.The minimum value is 0 and the maximum value is 6.
Measured: This scale will be collected at baseline and at 12 weeks.
Secondary outcomes (4)
Change in Social Network
Lubben's Social Network Scale
Measured: Baseline and at 12 weeks
Change in Mood
Geriatric Depression Scale
Measured: Baseline and at 12 weeks
Change in Quality of life
EQ-5D-5L survey
Measured: Baseline and at 12 weeks
all-cause mortality
Measured: Follow-up phone call at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Nov 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion3 Nov 2023 (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 multi-centered, three-arm, outcome assessor blinded randomized clinical trial will follow CONSORT reporting guidelines and is part of a program of research that adheres to the ORBIT model for developing complex behavioural interventions. In this model, the previous study by Lowthian and colleagues established the proof of concept, and the current trial Phase IIb is adequately powered to test whether two versions of the HOW R U? intervention are effective compared to a common standard care wait-list arm.
- 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
- Bolton Clarke Research Institute, Sunnybrook Research Institute, North York General Hospital, King's College London, University of Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228782
- Sponsor's protocol ID
- 21-0074E
- Acronym
- SIL
- Status last verified
- Sep 2021
- First submitted
- 1 Oct 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee JS, Rose L, Borgundvaag B, McLeod SL, Melady D, Mohindra R, Sinha SK, Wesson V, Wiesenfeld L, Kolker S, Kiss A, Lowthian J. Impact of a peer-support programme to improve loneliness and social isolation due to COVID-19: does adding a secure, user friendly video-conference solution work better than telephone support alone? Protocol for a three-arm randomised clinical trial. BMJ Open. 2024 Jan 9;14(1):e056839. doi: 10.1136/bmjopen-2021-056839.
PubMed 38199634
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb 3 Arm Randomized Clinical Pilot Study to Assess the Impact of a Peer-support Program to Improve Social Isolation and Loneliness Due to COVID-19 - Comparing the Addition of a Secure, User Friendly Video-conference Solution and Telephone Support Alone to a Waiting List Control Group
- ClinicalTrials.gov ID
- NCT05228782
- Acronym / sponsor ID
- SIL / 21-0074E
- 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
- Bolton Clarke Research Institute, Sunnybrook Research Institute, North York General Hospital, King's College London, University of Toronto
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 3 Nov 2023 (estimated)
- First posted
- 8 Feb 2022 (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 worsen older peoples' quality of life, risk of dementia, and contributes to 45,000 deaths/year in Canada - as much as smoking. Isolated people use the health care system more often, but have worse outcomes. Effective, inexpensive interventions exist but unfortunately they have not been implemented in Canada.
We partnered with the Australian developer of HOW R U?, an effective and feasible intervention that uses specially trained, older, hospital volunteers to provide peer support to combat isolation and loneliness in isolated older peers.
Little is known about older people's preferences for virtual care (telephone vs. video) nor their relative effectiveness. Thus we will compare two ways of delivering HOW R U: telephone support and a tested, secure user-friendly video conferencing app, aTouch Away® to a common control arm.
We also partnered with Emergency Medicine, Family Medicine, Geriatrics and Psychiatry to identify people who will benefit from peer support; and with Volunteer Services to recruit volunteers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This multi-centered, three-arm, outcome assessor blinded randomized clinical trial will follow CONSORT reporting guidelines and is part of a program of research that adheres to the ORBIT model for developing complex behavioural interventions. In this model, the previous study by Lowthian and colleagues established the proof of concept, and the current trial Phase IIb is adequately powered to test whether two versions of the HOW R U? intervention are effective compared to a common standard care wait-list arm.
| Arm | Type | Receives |
|---|---|---|
| HOW RU Intervention delivered by telephone | Experimental | Other: HOW R U? InterventionGroup Phone will receive the HOW RU? intervention over the telephone. |
| HOW RU Intervention delivered by video-call | Experimental | Other: HOW R U? InterventionGroup Video will receive the HOW RU? intervention delivered over video-call using the aTouch Away platform. |
| Wait-list Control Group | No intervention | –Control groups will be offered standard care through their referring service (i.e. their routine clinical follow-up). The control group will be offered HOW RU? telephone support outside of the main trial after their primary outcome assessment at 12 weeks |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Any community-dwelling person 70 years of age and older receiving care from the ED, Family Medicine, or Geriatric clinics at our two participating sites (MSH and NYGH) will be eligible.
Key exclusion criteria (1 listed)
- age less than 70 years; 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. To target the intervention for older people with loneliness a baseline de Jonge loneliness scores of 2.0 will be required for participation in the trial.
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 |
|---|---|---|
| HOW R U? InterventionHOW RU? intervention uses trained volunteer peers to provide strength-based support sessions weekly for 12 weeks. | Other | HOW RU Intervention delivered by telephone, HOW RU Intervention delivered by video-call |
Primary outcome
Change in De Jong Gierveld Loneliness Scale at Baseline
Time frame: This scale will be collected at baseline and at 12 weeks.
We will use the 6-item De Jong Gierveld loneliness scale as our primary outcome measure.The minimum value is 0 and the maximum value is 6.
4 secondary outcomes
Change in Social Network
Time frame: Baseline and at 12 weeks
Change in Mood
Time frame: Baseline and at 12 weeks
Change in Quality of life
Time frame: Baseline and at 12 weeks
all-cause mortality
Time frame: Follow-up phone call at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Derived from this study: PubMed 38199634Lee JS, Rose L, Borgundvaag B, McLeod SL, Melady D, Mohindra R, Sinha SK, Wesson V, Wiesenfeld L, Kolker S, Kiss A, Lowthian J. Impact of a peer-support programme to improve loneliness and social isolation due to COVID-19: does adding a secure, user friendly video-conference solution work better than telephone support alone? Protocol for a three-arm randomised clinical trial. BMJ Open. 2024 Jan 9;14(1):e056839. doi: 10.1136/bmjopen-2021-056839.
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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 HOW R U? Intervention 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 1 inclusion and 1 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 8 Feb 2022. 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 De Jong Gierveld Loneliness Scale at Baseline (time frame: This scale will be collected at baseline and at 12 weeks.). 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 NCT05228782, 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 8 Feb 2022.