Intergenerational Program for Social Isolation and Loneliness in Older Adults Discharged From the Emergency Department

NCT05998343 | Unknown

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

Brief Summary

Social isolation and loneliness worsens older adults' risk of dementia, quality of life, and death as much as smoking. Older adults are more likely to use emergency services and are also more likely to experience social isolation and loneliness than younger people. The emergency department is a new setting to screen for social isolation and loneliness in older adults and help accordingly. Social isolation and loneliness are experienced differently by different older adults. Different interventions combatting social isolation and loneliness may work better for different people, and little is known about older adult's preferences for specific types of interventions. HOW R U? is an effective and feasible intervention using same-generation peer support offered by trained hospital volunteers to reduce social isolation and loneliness in older adults. In partnership with the Australian developer of HOW R U?, this study will compare an intergenerational HOW R U? intervention using younger volunteers with the same-generation peer support intervention and a waitlist control arm. The investigators partnered with the staff of emergency departments and family medicine clinics to identify people who will benefit from an intervention combatting, and Volunteer Services to recruit volunteers. The investigators hypothesize that the older adults who receive the intergenerational HOW R U? intervention will have a greater improvement in social isolation and loneliness.

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 loneliness using De Jong Gierveld 6-item Loneliness Scale from Baseline to 12 Weeks

  The minimum value is 0 and the maximum value is 6, with the higher value corresponding with a greater degree of loneliness. It is divided into 4 clinically relevant categories: 0-1 = no loneliness, 2-3 = low levels of loneliness, 4-5 = moderate to severe loneliness, and 6 = severe loneliness.

  Measure at baseline, at 12 weeks (primary outcome) and 24 weeks (sustainability)

Secondary Outcomes (7)

• Change in perceived social support using Lubben Social Network Scale

  Measure at baseline, at 12 weeks and 24 weeks (sustainability)

• Change in mood using Geriatric Depression Scale

  Measure at baseline, at 12 weeks and 24 weeks (sustainability)

• Change in Quality of Life using Euro-Qual 5 Dimensions 5 Levels

  Measure at baseline, at 12 weeks and 24 weeks (sustainability)

• Change in Functional Status using Older Americans Resource Scale

  Measure at baseline, at 12 weeks and 24 weeks (sustainability)

• Change in self-perceptions of generativity using Loyola Generativity Scale

  Measure at baseline, at 12 weeks and 24 weeks (sustainability)

Other Outcomes (1)

• Feasibility and Process Outcome 1 - Participant preference

  Measure at 12 weeks

Study Arms (3)

HOW R U? intervention delivered by same-generation peer volunteer

EXPERIMENTAL

HOW R U?

Behavioral: Same-Generation Peer Support HOW R U?

HOW R U? intervention delivered by intergenerational volunteer

EXPERIMENTAL

Behavioral: Intergenerational HOW R U?

Waitlist control group

NO INTERVENTION

After the primary outcome assessment at 12 weeks, control group participants will be offered HOW R U? intervention support outside of the main trial. They will be allowed to choose either intergenerational or same-generation versions.

Interventions

Intergenerational HOW R U? BEHAVIORAL

1-on-1 discussion over telephone with a trained volunteer aged 19-39 years old who has received training to provide strength-based support sessions weekly for 12 weeks.

HOW R U? intervention delivered by intergenerational volunteer

Same-Generation Peer Support HOW R U? BEHAVIORAL

1-on-1 discussion over telephone with a trained volunteer aged 60 years or older who has received training to provide strength-based support sessions weekly for 12 weeks.

HOW R U? intervention delivered by same-generation peer volunteer

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 the two participating sites (MSH and NYGH) will be eligible.
• Baseline de Jong loneliness scores of 2.0 will be required for participation in the trial.

You may not qualify if:

• Age less than 70 years;
• Patients with 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.
• Patients without any mobile phone or landline.
• Volunteers:
• Volunteers will be 60 years of age or older to qualify as peer-support volunteers.
• Volunteers will be 19-39 years of age to qualify as intergenerational volunteers.

Sponsors & Collaborators

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

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1XS, Canada

RECRUITING

Related Publications (1)

• Zheng D, Rose L, Borgundvaag B, McLeod SL, Melady D, Mohindra R, Sinha S, Wesson V, Wiesenfeld L, Kolker S, Kiss A, Lowthian JA, Lee JS. Impact of an intergenerational program to improve loneliness and social isolation in older adults initiated at the time of emergency department discharge: study protocol for a three-arm randomized clinical trial. Trials. 2024 Jun 28;25(1):425. doi: 10.1186/s13063-024-08250-2.

  PMID: 38943176 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

David Zheng, MD

CONTACT

5199335838; dzheng33@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary outcomes will be assessed after 12 weeks by a research assistant who is blinded to the intervention group and who has had no prior contact with the participants. Participants will also be instructed not to reveal the intervention they have received to any research staff.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a three-arm outcome assessor blinded randomized controlled trial will follow SPIRIT reporting guidelines and is part of a program of research that adheres to the ORBIT model for developing complex behavioural interventions.

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 18, 2023
• Study Start: November 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: February 1, 2024
• Last Updated: August 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: 18 months from study completion

Locations

CA (1)