COVID-19 and Social Isolation and Loneliness Trial

Loneliness Clinical Trial

— SIL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05228782
• Other study ID #: 21-0074E
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 3, 2023

Study information

• Verified date: September 2021
• Source: Mount Sinai Hospital, Canada
• Contact: Jacques Lee, MD
• Phone: 4168771447
• Email: Jacques.lee[@]sinaihealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 141
• Est. completion date: November 3, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Geriatric
• Loneliness
• Social Isolation

Intervention

Other:
• HOW R U? Intervention
HOW RU? intervention uses trained volunteer peers to provide strength-based support sessions weekly for 12 weeks.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (6)

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

Country where clinical trial is conducted

Canada, 

Outcome

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