COVID-19 and Social Isolation and Loneliness Trial

Not Applicable

• Conditions: Loneliness; Geriatric; Social Isolation
• Interventions: Other: HOW R U? Intervention

• Registration Number: NCT05228782
• Lead Sponsor: Mount Sinai Hospital, Canada

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-10-01
• Study Start: 2021-11-01
• Study First Submitted QC: 2022-02-05
• Last Update Submitted: 2022-02-05
• Study First Posted: 2022-02-08
• Last Update Posted: 2022-02-08
• Primary Completion: 2022-11-01
• Study Completion: 2023-11-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 141

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HOW RU Intervention delivered by video-call	HOW R U? Intervention	Group Video will receive the HOW RU? intervention delivered over video-call using the aTouch Away platform.
HOW RU Intervention delivered by telephone	HOW R U? Intervention	Group Phone will receive the HOW RU? intervention over the telephone.

Primary Outcome Measures

Name	Time	Method
Change in De Jong Gierveld Loneliness Scale at Baseline	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada