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

Loneliness Clinical Trial

— SIL  

Official title:

Improving Social Isolation and Loneliness in Older Adults Discharged From the Emergency Department - Comparing an Intergenerational Versus Same Generation Peer-support Intervention Versus Common Wait List Control Group in a Three Arm RCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05998343
• Other study ID #: 21-0074-E
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: July 2023
• Source: Mount Sinai Hospital, Canada
• Contact: Jacques Lee, MD
• Phone: 4168771447
• Email: Jacques.lee[@]sinaihealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 141
• Est. completion date: February 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Geriatric
• Loneliness
• Social Isolation

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Bolton Clarke Research Institute, King's College London, North York General Hospital, Sunnybrook Research Institute, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility and Process Outcome 1 - Participant preference	To assess for participant preference for same-generation peer support versus intergenerational HOW R U? intervention, we will use a 5-point Likert scale with the following options: "I strongly prefer peer support", "I prefer peer support", "neutral", "I prefer intergenerational" and "I strongly prefer intergenerational".	Measure at 12 weeks
Primary	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	Change in perceived social support using Lubben Social Network Scale	The Lubben Social Network Scale is a measure of perceived social support received from the family and friends and consists of 6 items each of which is scored from 0 to 5: none = 0, one = 1, two = 2, three or four = 3, five through eight = 4, nine or more = 5. The total score ranges from 0 to 30, and a score of 12 and lower indicates a status of "at-risk" for social isolation	Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Secondary	Change in mood using Geriatric Depression Scale	The Geriatric Depression Scale is a 15-item scale of mood that is extensively validated in older populations to screen for depression. Scores range from 0 to 15. A score of 0-4 is considered normal, and a score of 5 or higher is considered indicative of depression with higher scores indicating higher severity of depression.	Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Secondary	Change in Quality of Life using Euro-Qual 5 Dimensions 5 Levels	EQ-5D-5Lin 5 dimensions. In each dimension, quality of life can be measured from 1 (best quality of life) to 5 (worst quality of life), giving a possible score of 5-25. A higher score indicates worse quality of life. (Euro-Qual 5 Dimensions 5 Levels) scale assesses quality of life	Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Secondary	Change in Functional Status using Older Americans Resource Scale	The Older Americans Resource Scale (OARS) consists of 7 activities of daily living (ADL) questions and 7 instrumental activities of daily living (IADL) all rated as "without any help" (2 points), "with some help" (1 point), or "completely unable" (0 points). The ADL and IADL scores can be used separately or combined to produce an overall OARS score from 0-28.	Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Secondary	Change in self-perceptions of generativity using Loyola Generativity Scale	The Loyola Generativity Scale is a 20-item scale with each question answered 0 = statement never applies to you, 1 = statement only occasionally or seldom applies to you, 2 = statement applies to you fairly often, or 3 = statement applies to you very often or nearly always.; The higher the score, the greater the sense of generativity.	Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Secondary	Perceived benefit to participant at 12 weeks	Perceived benefit by the participant pre- and post-intervention will be assessed using the question "Compared to working with a volunteer around the same age as you, you think that working with a younger volunteer is:" followed by a 5-point Likert scale with the following options: A lot less helpful for me, a little less helpful for me, about the same for me, a little more helpful for me, or a lot more helpful for me.	Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Secondary	Perceived benefit to volunteer at 12 weeks	Perceived benefit by the participant for the volunteer pre- and post-intervention will be assessed using the question "Compared to working with a volunteer around the same age as you, you think that working with a younger volunteer is:" followed by a 5-point Likert scale with the following options: A lot less helpful for the volunteer, a little less helpful for the volunteer, about the same for the volunteer, a little more helpful for the volunteer, or a lot more helpful for volunteer.	Measure at baseline, at 12 weeks and 24 weeks (sustainability)