Technology Tools for Cognitive Support for Health Management Activities for Aging Adults With and Without Mild Cognitive Impairment (Research Project 3)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Project 3, Phase 2: Mean Perceived System Usefulness
研究概览
简要总结
The goal for this project is to support the cognitive components of older adults' health-management activities through development of digital assistant technology tools tailored to three exemplar healthcare management task activities: accessing support services, managing healthcare finances, and using the health-management tools provided by Medicare.gov. This project will leverage the machine-intelligence expertise of our collaborators and our experience in developing and evaluating technologies for supporting the health and wellbeing needs of older adults to harness technology to provide cognitive support to aging adults, including those with Mild Cognitive Impairment (MCI) and lower SES.
详细描述
The overarching goal of the project is to enable diverse older adults, including those of lower SES or with cognitive impairments (e.g., MCI), to achieve their health goals by supporting the cognitive components of health-management activities, through development of digital assistant technology tools. Tool development will be guided by an understanding of the preferences, needs, and cognitive capabilities and limitations of older adults. Each of the CREATE sites will lead efforts. CREATE resources will be used to maximal potential through utilization of the machine learning and artificial intelligence expertise of our partners at the WCM site for support of the development of digital assistant technology tools for medicare. Importantly, data collection related to development and evaluation of the tools for each of the task activities will occur at all sites to maximize the design of the cognitive support tools and the generalizability of the findings.
Clinical Trial, the primary objective is focused on evaluating the feasibility, acceptability and usability of the SideKick digital support tool (adapted for this study for Medicare) with a diverse sample of adults age 60+ with and without a cognitive impairment. This is a feasibility trial. The study design is a pilot RCT. Following a baseline assessment, participants will be randomized into a Medicare.gov Condition or the SideKick condition. Participants will complete a series of queries related to Medicare enrollment and plan selection (that vary in complexity) using medicare.gov or Sidekick. Their performance and perceptions (e.g., challenges, usability, usefulness, etc.) will be evaluated upon completion of the queries.
This clinical trial was originally registered as part of NCT05811338.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Some internet proficiency is required; participants will need to answer Yes to the following:
- •Can you use the Internet to access a website, for example, amazon.com?
- •Can you use search engines like Google to search for information on the Internet?
- •English speaking.
- •6th grade literacy.
- •Aged 60 or older.
- •TICS-m with a score between 22-37 for MCI and >37 for normal.
- •Able to read from a newspaper.
排除标准
- •blindness
- •deafness (inability to engage in telephone screening due to hearing difficulties)
- •terminal illness
- •severe motor impairments (e.g., severe tremors or debilitating arthritis in the hands),
- •TICS-m <
- •All Phase 1 study participants (interview and observational study): have you ever participated in a study that interviewed you about your experience with Medicare or asked you to search for Medicare information?
研究组 & 干预措施
Sidekick Condition
Participants will be given a brief introduction to Large Language Models, how they can be used to solve queries, and introduced to Sidekick. Some simple example queries will be used to demonstrate its use, how to construct prompts, and to illustrate the nature of Sidekick's responses. Participants will also be instructed about different degrees of specificity of information and other customization features of Sidekick and how to use responses as a springboard for iterative prompting (sequential queries).
干预措施: Project 3, Phase 2: Clinical Trial (Behavioral)
Usual-Tool Control Condition
Participants will be asked to open the medicare.gov website. They will be shown the basic structure of the homepage and the distinctions between tabs on the website. Examples of information that can be obtained from these different tabs will be demonstrated. Navigation between different parts of the website will also be demonstrated.
干预措施: Project 3, Phase 2: Clinical Trial (Behavioral)
结局指标
主要结局
Project 3, Phase 2: Mean Perceived System Usefulness
时间窗: Immediately following completion of the task performance session
Participants' perception of the usefulness of the system with 7 items with 3 subscales, included workload, trust, and usability. The Workload subscale will be computed from the average of a. the mental effort and b. the physical effort responses. Average c,d,e for the trust scale, and average f,g for a usability scale. Higher scores indicated higher workload, higher trust, and higher usability.
Project 3, Phase 2: Sum of Performance Accuracy
时间窗: Immediately following completion of the task performance session
Accuracy will be evaluated based on whether the participants provided the accurate answer for each query (0=incorrect and 1=correct). Accuracy is summed across 12 queries with possible scores ranging from 0-12, higher scores indicate higher accuracy.
Project 3, Phase 1: Qualitative interview assessment regarding Healthcare Challenges
时间窗: During one-time condition session at Baseline Assessment
Analysis of interview transcripts will identify common themes that will be the target of technology-based support. The general script for interviews with older adults will start with a) demographics and medical history; (b) health management strategies - current approaches for monitoring and managing chronic conditions and maintaining general wellness; (c) current use, awareness of, openness to, and concerns about technologies for health management; (d) general challenges experienced and barriers to successful health management. Investigators will then have sections of the interview script tailored to the three activity categories: access to services; financial health management, and Medicare utilization.
Project 3, Phase 3: Mixed-method assessment of usability challenges assessed using the Usability Metric for User Experience (UMUX-LITE)
时间窗: During one-time condition session at Baseline Assessment
User testing will have participants "think aloud" as they solve healthcare problems, and data will be coded for frustration and specific challenges experienced. The investigators will also use classic usability measures, for example, UMUX-LITE. The Usability Metric for User Experience (UMUX-Lite) is a two-item Likert scale used for the subjective assessment of an application's perceived usability. On a 7 point scale, with 0 being strongly disagree and 6 being strongly agree, higher scores are reflective of a greater satisfaction with the system.
Project 3, Phase 3: Comprehension and Decision Making Accuracy
时间窗: During one-time condition session at Baseline Assessment
For hypothetical healthcare challenges participants will be presented with, they will afterward be tested on their comprehension of important terms, and their decision-making accuracy will be evaluated, for participants with and without access to novel technology tools developed as part of this project. The comprehension and decision making accuracy measure is to be developed based on projects 1 and 2 of the study.
次要结局
- Project 3, Phase 3: Comprehension and Decision Making Tool Usability(During one-time condition session at Baseline Assessment)