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

NCT ID: NCT05998343

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2024-02-01

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.

Detailed Description

Introduction:

Social isolation and loneliness (SIL) worsens mortality and other outcomes among older adults as much as smoking. The investigators previously tested the impact of the HOW R U? intervention using peer support from similar aged volunteers and demonstrated reduced SIL among older adults discharged from the Emergency Department (ED). Generativity, defined as "the interest in establishing and guiding the next generation" can provide an alternative theoretical basis for reducing SIL via intergenerational programs between members of younger and older generations. The current study will examine the impact of younger intergenerational volunteers providing the HOW R U? intervention. As part of a program of research following the Obesity-Related Behavioral Intervention Trials (ORBIT ) model, findings of this RCT will be used to define which intervention characteristics are most effective in reducing SIL. This trial builds on feasibility work conducted in the investigators' previous trial (NCT 05228782).

Methods and Analysis:

The investigators will compare the use of the same-generation peer support HOW RU? intervention to support by intergenerational volunteers. The investigators will use a common wait list control group in this three-arm randomized controlled trial (RCT).

Trained volunteers will deliver 12 weekly telephone support calls. The investigators will recruit 141 participants ≥70 years of age with baseline loneliness (six-item De Jong loneliness score of 2 or greater) from two EDs. Research staff will assess change in loneliness (De Jong Loneliness Scale), social isolation (Lubben's Social Network Scale), depression (Geriatric Depression Score), quality of life (EQ-5D-5L), functional status (Older Americans Resource Scale), generativity (Loyola Generativity Scale), and perceived benefit at baseline (subjective Likert scale), at 12-14 weeks, and 24-26 weeks post-intervention. The study will follow the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.

Ethics and Dissemination:

The participating research ethics boards have granted ethics approval, and the participants randomized to the waitlist control group will be offered their choice of intergenerational or same-generation HOW R U? interventions after 12 weeks. Results will be shared through journal publications, conference presentations, social media, and through the International Federation of Emergency Medicine.

Conditions

Social Isolation; Loneliness; Geriatric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

HOW R U?

Group Type: EXPERIMENTAL

Same-Generation Peer Support HOW R U?

Intervention Type: 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 intergenerational volunteer

Group Type: EXPERIMENTAL

Intergenerational HOW R U?

Intervention Type: 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.

Waitlist control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intergenerational HOW R U?

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.

Intervention Type: BEHAVIORAL

Same-Generation Peer Support HOW R U?

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.

Intervention Type: BEHAVIORAL

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 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

North York General Hospital

OTHER

Sponsor Role: collaborator

Sunnybrook Research Institute

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Bolton Clarke Research Institute

UNKNOWN

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jacques Lee, MD

Role: CONTACT

Jacques.lee@sinaihealth.ca

4168771447

David Zheng, MD

Role: CONTACT

dzheng33@uwo.ca

5199335838

Facility Contacts

Jacques Lee, MD

Role: primary

Jacques.lee@sinaihealth.ca

References

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.

Reference Type: DERIVED

PMID: 38943176 (View on PubMed)

Other Identifiers

21-0074-E

Identifier Type: -

Identifier Source: org_study_id