Clinical trial NCT05228782: COVID-19 and Social Isolation and Loneliness Trial
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Isolation
Loneliness
Geriatric
Keywords: Loneliness
Social Isolation
Emergency Department
Geriatrics
Geriatric Psychiatry
Family Medicine
Randomized Clinical Trial
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Bolton Clarke Research Institute
name: Sunnybrook Research Institute
name: North York General Hospital
name: King's College London
name: University of Toronto
First posted: 2022-02-08
Enrollment: 141
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change in De Jong Gierveld Loneliness Scale at Baseline
timeFrame: This scale will be collected at baseline and at 12 weeks.
Secondary outcomes:
measure: Change in Social Network
timeFrame: Baseline and at 12 weeks
measure: Change in Mood
timeFrame: Baseline and at 12 weeks
measure: Change in Quality of life
timeFrame: Baseline and at 12 weeks
measure: all-cause mortality
timeFrame: Follow-up phone call at 12 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
References: