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临床试验/NCT05599503
NCT05599503已完成不适用

Social Assistive Robot Interface for People With Alzheimers and Other Dementias to Aid in Care Management

SimpleC, LLC4 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2022年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
4
主要终点
Change in Caregiver Guilt Scale. A 4-point scale with higher score indicating higher guilt.

研究概览

简要总结

This study will be conducted to test a Socially-Assistive Robot (SAR) system for residents in an Assisted Living environment. The goal of the SAR system is to enhance social engagement and connectedness. The system engages residents via robot-facilitated activities such as trivia and reminder and is integrated with the SimpleC Wellness Platform.

详细描述

This is a mixed-method study to assess the effectiveness of the SAR system. The study includes behavior/lifestyle intervention that are delivered via a robot and/or tablet. The study intervention is a Social Assistive Robot (SAR) System. The SAR system contains the SimpleC Platform, physical robot, virtual agent/robot.

The goal is to engage residents in a natural language conversation as psychosocial support (enhancing mood, mitigating the effects of loneliness, and enhancing social connection and communication) and provide value to the organization and its staff.

Research questions include:

  1. Are existing and new residents engaged and satisfied with the Technology Intervention Program?
  2. What are the benefits (health, behavioral, economic, and social) of the virtual agent and physical robot?
  3. Which users will adopt the SAR system?
  4. What are facilitators and barriers to SAR system adoption?
  5. Does Technology Acceptance Theory explain adoption over time?
  6. Do changing needs affect changing technology attitude?
  7. What are guidelines for implementation and design?

Sample: 270 individuals will participate: 90 residents, 90 family, and 90 staff across different study locations. Enrollment will be stopped upon reaching saturation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Resident Inclusion Criteria:
  • Aged 50+ years
  • Any gender
  • Fluent in English
  • New or current user of SimpleC
  • At risk for MCI; MCI; moderate / cognitive impairment (MMSE score of 13 or higher)
  • Family Member Inclusion Criteria:
  • Aged 18+ years
  • Any gender
  • Fluent in English
  • Family or friend of resident
  • New or current user of SimpleC
  • No diagnosis of dementia or related disorder
  • Staff Inclusion Criteria:
  • Aged 18+ years
  • Any gender
  • Fluent in English
  • Works for the Senior Housing Community
  • New or current user of SimpleC

排除标准

  • Comorbidities or psychiatric history that would preclude study participation
  • Expecting to move during the study (i.e., move out of facility)
  • Both legally deaf and blind
  • Not able to press tablet buttons
  • Not able to verbally answer questionnaires
  • Family Caregiver Exclusion Criteria:
  • Comorbidities or psychiatric history that would preclude study participation
  • Expecting to move during the study (i.e., move out of facility)
  • Both legally deaf and blind
  • Not able to press tablet buttons
  • Staff Exclusion Criteria:
  • Expecting to move during the study (i.e., move out of facility)
  • Both legally deaf and blind

结局指标

主要结局

Change in Caregiver Guilt Scale. A 4-point scale with higher score indicating higher guilt.

时间窗: Baseline, Midpoint (3 months), Final (6 months)

\[Questionnaire\] Family caregiver feelings of guilt.

Change in Quality of Life. A 13-item survey with high scores indicating higher quality of life.

时间窗: Baseline, Midpoint (3 months), Final (6 months)

\[Questionnaire\] Assessment of different aspects of quality of life, including physical health, energy, family, money.

Change in Perceived Stress Scale. A 5-point scale with higher scores indicating higher stress.

时间窗: Baseline, Midpoint (3 months), Final (6 months)

\[Questionnaire\] Family caregiver experience of stress in the past 4 months. Modification: Answer as it relates to caregiving.

Change in Technology Acceptance and Experience Questionnaire. A scale with high scores indicating higher acceptance.

时间窗: Midpoint (3 months), Final (6 months)

\[Questionnaire\] Assessment of users' perceived ease of use, usefulness, and satisfaction of using the technology.

Change in Robotic Social Attributes Scale (RoSAS). An 18-item scale with high scores indicating positive attitudes for dimensions of warmth and competency and a negative attitude for dimension of discomfort.

时间窗: Midpoint (3 months), Final (6 months)

\[Questionnaire\] Perception and judgment of Social Assistive Robot social attributes on 3 dimensions: Warmth, competency, and discomfort

次要结局

  • Requirements(6 months)
  • Usability and usefulness(6 months)
  • Participation Pattern(6 months)
  • Technology acceptance and adoption Interview.(Final (6 months))
  • Conversation quality(6 months)
  • Value proposition/Economic Impact(6 months)
  • Affect(6 months)

研究者

发起方
SimpleC, LLC
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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