COVID-19 and Social Isolation and Loneliness Trial (SIL)

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.

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 Overview

• Status: Recruiting
• Conditions: Loneliness; Geriatric; Social Isolation
• Intervention / Treatment: Other: HOW R U? Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 141
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacques Lee, MD; Phone Number: 4168771447; Email: Jacques.lee@sinaihealth.ca
• Study Contact Backup: Name: Joanna Yeung, HBSc; Phone Number: 6473089440; Email: Joanna.yeung@sinaihealth.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1XS
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Jacques Lee, MD; Email: Jacques.lee@sinaihealth.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HOW RU Intervention delivered by telephone; Group Phone will receive the HOW RU? intervention over the telephone.	Other: HOW R U? Intervention; HOW RU? intervention uses trained volunteer peers to provide strength-based support sessions weekly for 12 weeks.
Experimental: HOW RU Intervention delivered by video-call; Group Video will receive the HOW RU? intervention delivered over video-call using the aTouch Away platform.	Other: HOW R U? Intervention; HOW RU? intervention uses trained volunteer peers to provide strength-based support sessions weekly for 12 weeks.
No Intervention: Wait-list Control Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This scale will be collected at baseline and at 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Social Network	Lubben's Social Network Scale	Baseline and at 12 weeks
Change in Mood	Geriatric Depression Scale	Baseline and at 12 weeks
Change in Quality of life	EQ-5D-5L survey	Baseline and at 12 weeks
all-cause mortality		Follow-up phone call at 12 weeks

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Collaborators: King's College London; University of Toronto; Sunnybrook Research Institute; North York General Hospital; Bolton Clarke Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 3, 2023

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: February 5, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 5, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Emergency Department; Loneliness; Geriatrics; Social Isolation; Randomized Clinical Trial; Family Medicine; Geriatric Psychiatry
• Other Study ID Numbers: 21-0074E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No