The Impact of Socially Supportive Robotic Intervention on Loneliness, Depression, Self-agency and Well-being in Long-term Care Residents: A Three-Arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Loneliness
研究概览
简要总结
The purpose of this study is to compare the efficacy of a personalized, co-designed robot interaction against a standardized, fixed robot interaction for reducing loneliness, depression, as well as improving self-agency and quality of life in older adults.
This is a three-arm randomized controlled trial. The study will be conducted at a community center in Fuzhou, China, with 100 participants aged 65+ recruited from the facility. The participants will be randomly assigned to one of three conditions: (1) Co-designed robot (CL) group receiving a personalized robot interaction with a structured co-design ceremony; (2) Standard robot (SL) group interacting with an identical robot without personalization features; or (3) An attention-controlled usual care (CU) group. The intervention comprises 16 sessions (two weekly 20-minute sessions over eight weeks). The primary outcomes are loneliness and depressive symptoms. Secondary outcomes include general self-efficacy, quality of life, as well as staff and participants' perceptions of the robot. Mechanism measures (i.e., engagement, self-disclosure) and manipulation checks (e.g., perceived personal role) will be employed to elucidate the underlying theoretical pathways. Data will be collected at baseline (T0), after the initial 2-week co-design period (T1), post-intervention (T2, Week 8), and at 1-month (T3) and 3-month (T4) follow-ups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •of this program are: (1) being aged 65 or above, (2) living within the elderly community center for at least 1 month, and (3) being capable of interacting with a robot.
- •The participants were not eligible if they were: (1) already engaged in other socially assistive robot programs, (2) diagnosed with severe psychiatric problems, (3) bed-bound, or (4) living in an area with no Internet coverage.
排除标准
- 未提供
结局指标
主要结局
Loneliness
时间窗: From enrollment to the end of treatment at 24 weeks
Measure the loneliness of participants at baseline before the intervention (T0), at the end of Week 2 (T1) following the initial interaction period, at the end of Week 8 (T2) upon completion of the core intervention phase, and at Week 12 (T3) and Week 24 (T4) to assess the sustained effects of the intervention.
Depression
时间窗: From enrollment to the end of treatment at 24 weeks.
Depressive Symptoms will be assessed using the Chinese version of the 15-item Geriatric Depression Scale (GDS-15) at baseline before the intervention (T0), at the end of Week 2 (T1) following the initial interaction period, at the end of Week 8 (T2) upon completion of the core intervention phase, and at Week 12 (T3) and Week 24 (T4).
次要结局
- Self-Efficacy(From enrollment to the end of treatment at 24 weeks)
- Quality of life and Wellbeing(From enrollment to the end of treatment at 24 weeks)
研究者
Jianan Zhao
principle investigator
Shanghai Jiao Tong University School of Medicine