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

Primary Purpose

Social Isolation, Loneliness, Geriatric

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intergenerational HOW R U?
Same-Generation Peer Support HOW R U?
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Social Isolation focused on measuring Loneliness, Social Isolation, Emergency Department, Geriatrics, Geriatric Psychiatry, Family Medicine, Randomized Clinical Trial

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mount Sinai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

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

HOW R U? intervention delivered by intergenerational volunteer

Waitlist control group

Arm Description

HOW R U?

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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
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.
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.
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.
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.

Full Information

First Posted
July 24, 2023
Last Updated
August 16, 2023
Sponsor
Mount Sinai Hospital, Canada
Collaborators
North York General Hospital, Sunnybrook Research Institute, University of Toronto, Bolton Clarke Research Institute, King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT05998343
Brief Title
Intergenerational Program for Social Isolation and Loneliness in Older Adults Discharged From the Emergency Department
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada
Collaborators
North York General Hospital, Sunnybrook Research Institute, University of Toronto, Bolton Clarke Research Institute, King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Isolation, Loneliness, Geriatric
Keywords
Loneliness, Social Isolation, Emergency Department, Geriatrics, Geriatric Psychiatry, Family Medicine, Randomized Clinical Trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
141 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HOW R U? intervention delivered by same-generation peer volunteer
Arm Type
Experimental
Arm Description
HOW R U?
Arm Title
HOW R U? intervention delivered by intergenerational volunteer
Arm Type
Experimental
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intergenerational HOW R U?
Intervention Description
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
Intervention Name(s)
Same-Generation Peer Support HOW R U?
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in loneliness using De Jong Gierveld 6-item Loneliness Scale from Baseline to 12 Weeks
Description
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.
Time Frame
Measure at baseline, at 12 weeks (primary outcome) and 24 weeks (sustainability)
Secondary Outcome Measure Information:
Title
Change in perceived social support using Lubben Social Network Scale
Description
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
Time Frame
Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Title
Change in mood using Geriatric Depression Scale
Description
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.
Time Frame
Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Title
Change in Quality of Life using Euro-Qual 5 Dimensions 5 Levels
Description
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
Time Frame
Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Title
Change in Functional Status using Older Americans Resource Scale
Description
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.
Time Frame
Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Title
Change in self-perceptions of generativity using Loyola Generativity Scale
Description
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.
Time Frame
Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Title
Perceived benefit to participant at 12 weeks
Description
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.
Time Frame
Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Title
Perceived benefit to volunteer at 12 weeks
Description
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.
Time Frame
Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Other Pre-specified Outcome Measures:
Title
Feasibility and Process Outcome 1 - Participant preference
Description
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".
Time Frame
Measure at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacques Lee, MD
Phone
4168771447
Email
Jacques.lee@sinaihealth.ca
First Name & Middle Initial & Last Name or Official Title & Degree
David Zheng, MD
Phone
5199335838
Email
dzheng33@uwo.ca
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1XS
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Lee, MD
Email
Jacques.lee@sinaihealth.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified individual level data that support the findings of this study will be available on reasonable request from the Principal Investigator Dr. Jacques Lee (Jacques.lee@sinaihealth.ca) to improve scientific transparency, verify the study findings and generating new knowledge. As this research was supported by public funding, request for commercial purposes will require approval of the funding agency.
IPD Sharing Time Frame
18 months from study completion

Learn more about this trial

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

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