Skip to content

COVID-19 and Social Isolation and Loneliness Trial

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05228782
Acronym
SIL
Enrollment
141
Registered
2022-02-08
Start date
2021-11-01
Completion date
2023-11-03
Last updated
2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geriatric, Loneliness, Social Isolation

Keywords

Loneliness, Social Isolation, Emergency Department, Geriatrics, Geriatric Psychiatry, Family Medicine, Randomized Clinical Trial

Brief 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. 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.

Interventions

OTHERHOW R U? Intervention

HOW RU? intervention uses trained volunteer peers to provide strength-based support sessions weekly for 12 weeks.

Sponsors

Bolton Clarke Research Institute
CollaboratorUNKNOWN
Sunnybrook Research Institute
CollaboratorOTHER
North York General Hospital
CollaboratorOTHER
King's College London
CollaboratorOTHER
University of Toronto
CollaboratorOTHER
Mount Sinai Hospital, Canada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

We will use intention-to-treat analysis for the primary outcome to further protect against selection bias. It is not feasible to blind participants to the intervention. Primary outcomes will be assessed after 12 weeks by a research assistant who has had no previous contact with participants and is blinded to the intervention group.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in De Jong Gierveld Loneliness Scale at BaselineThis 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.

Secondary

MeasureTime frameDescription
Change in Social NetworkBaseline and at 12 weeksLubben's Social Network Scale
Change in MoodBaseline and at 12 weeksGeriatric Depression Scale
Change in Quality of lifeBaseline and at 12 weeksEQ-5D-5L survey
all-cause mortalityFollow-up phone call at 12 weeks

Countries

Canada

Contacts

Primary ContactJacques Lee, MD
Jacques.lee@sinaihealth.ca4168771447
Backup ContactJoanna Yeung, HBSc
Joanna.yeung@sinaihealth.ca6473089440

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026