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Clinical Trials/NCT05228782
NCT05228782
Unknown
Not Applicable

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

Mount Sinai Hospital, Canada1 site in 1 country141 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Social Isolation
Sponsor
Mount Sinai Hospital, Canada
Enrollment
141
Locations
1
Primary Endpoint
Change in De Jong Gierveld Loneliness Scale at Baseline
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
November 3, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change in Social Network(Baseline and at 12 weeks)
  • Change in Mood(Baseline and at 12 weeks)
  • Change in Quality of life(Baseline and at 12 weeks)
  • all-cause mortality(Follow-up phone call at 12 weeks)

Study Sites (1)

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