Clinical trial NCT05998343: Intergenerational Program for Social Isolation and Loneliness in Older Adults Discharged From the Emergency Department
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
Overall status: RECRUITING
Phase: NA
Conditions: Social Isolation
Loneliness
Geriatric
Keywords: Loneliness
Social Isolation
Emergency Department
Geriatrics
Geriatric Psychiatry
Family Medicine
Randomized Clinical Trial
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: North York General Hospital
name: Sunnybrook Research Institute
name: University of Toronto
name: Bolton Clarke Research Institute
name: King's College London
First posted: 2023-08-18
Enrollment: 141
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in loneliness using De Jong Gierveld 6-item Loneliness Scale from Baseline to 12 Weeks
timeFrame: Measure at baseline, at 12 weeks (primary outcome) and 24 weeks (sustainability)
Secondary outcomes:
measure: Change in perceived social support using Lubben Social Network Scale
timeFrame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
measure: Change in mood using Geriatric Depression Scale
timeFrame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
measure: Change in Quality of Life using Euro-Qual 5 Dimensions 5 Levels
timeFrame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
measure: Change in Functional Status using Older Americans Resource Scale
timeFrame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
measure: Change in self-perceptions of generativity using Loyola Generativity Scale
timeFrame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
measure: Perceived benefit to participant at 12 weeks
timeFrame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
measure: Perceived benefit to volunteer at 12 weeks
timeFrame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
Other outcomes:
measure: Feasibility and Process Outcome 1 - Participant preference
timeFrame: Measure at 12 weeks
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
References: