COVID-19 and Social Isolation and Loneliness Trial

NCT05228782 | Unknown

• 1 other identifier: 21-0074E
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Isolation; Loneliness; Geriatric

Keywords

Loneliness; Social Isolation; Emergency Department; Geriatrics; Geriatric Psychiatry; Family Medicine; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Arms (3)

HOW RU Intervention delivered by telephone

EXPERIMENTAL

Group Phone will receive the HOW RU? intervention over the telephone.

Other: HOW R U? Intervention

HOW RU Intervention delivered by video-call

EXPERIMENTAL

Group Video will receive the HOW RU? intervention delivered over video-call using the aTouch Away platform.

Other: HOW R U? Intervention

Wait-list Control Group

NO INTERVENTION

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

Interventions

HOW R U? Intervention OTHER

HOW RU? intervention uses trained volunteer peers to provide strength-based support sessions weekly for 12 weeks.

HOW RU Intervention delivered by telephone; HOW RU Intervention delivered by video-call

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Bolton Clarke Research Institute: collaborator
• Sunnybrook Research Institute: collaborator
• North York General Hospital: collaborator
• King's College London: collaborator
• University of Toronto: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1XS, Canada

RECRUITING

Related Publications (1)

• Lee JS, Rose L, Borgundvaag B, McLeod SL, Melady D, Mohindra R, Sinha SK, Wesson V, Wiesenfeld L, Kolker S, Kiss A, Lowthian J. Impact of a peer-support programme to improve loneliness and social isolation due to COVID-19: does adding a secure, user friendly video-conference solution work better than telephone support alone? Protocol for a three-arm randomised clinical trial. BMJ Open. 2024 Jan 9;14(1):e056839. doi: 10.1136/bmjopen-2021-056839.

  PMID: 38199634 DERIVED

MeSH Terms

Conditions

Social Isolation; Emergencies

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jacques Lee, MD

CONTACT

4168771447; Jacques.lee@sinaihealth.ca

Joanna Yeung, HBSc

CONTACT

6473089440; Joanna.yeung@sinaihealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: We will use intention-to-treat analysis for the primary outcome to further protect against selection bias. It is not feasible to blind participants to the intervention. Primary outcomes will be assessed after 12 weeks by a research assistant who has had no previous contact with participants and is blinded to the intervention group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: February 8, 2022
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 3, 2023
• Last Updated: February 8, 2022

Record last verified: 2021-09

Locations

CA (1)