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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Change in loneliness using De Jong Gierveld 6-item Loneliness Scale from Baseline to 12 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in loneliness using De Jong Gierveld 6-item Loneliness Scale from Baseline to 12 Weeks
时间窗: Measure at baseline, at 12 weeks (primary outcome) and 24 weeks (sustainability)
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.
次要结局
- Change in perceived social support using Lubben Social Network 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 mood using Geriatric Depression Scale(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))
- Perceived benefit to participant at 12 weeks(Measure at baseline, at 12 weeks and 24 weeks (sustainability))
- Perceived benefit to volunteer at 12 weeks(Measure at baseline, at 12 weeks and 24 weeks (sustainability))