COVID-19 and Social Isolation and Loneliness Trial

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Geriatric, Social Isolation, Loneliness

Intervention / Treatment
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* Other: HOW R U? Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Loneliness, Social Isolation, Emergency Department, Geriatrics, Geriatric Psychiatry, Family Medicine, Randomized Clinical Trial