Technological Innovation to Support Medication Safety and Optimization in Older Adults Living Alone With Cognitive Decline
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Medication self-management
研究概览
简要总结
This clinical trial is studying an online tool that may help older adults safely manage their medications at home. The study focuses on older adults who live alone and have memory concerns or mild changes in thinking. Many people in this group take several medications, which can make it hard to keep track of when and how to take them, notice side effects, or know when to ask for help.
In this study, participants use an online self-monitoring platform to record any problems, symptoms, or concerns they have while taking their medications. The platform also provides helpful education and suggestions for managing medications and symptoms. Participants can share summaries from the platform with their health care team, which may help improve communication and support.
The goal of the study is to see whether this tool can help older adults feel more confident, informed, and prepared to manage their medications safely while living at home.
详细描述
The main goal of this study is to find out whether an online self-monitoring tool can help older adults who live alone and have memory concerns or mild changes in thinking manage their medications more safely and easily.
The study will look at whether the tool helps people: (1) take their medications as prescribed; (2) keep track of medication-related problems or concerns; (3) feel more confident managing medications at home; and (4) reduce stress, confusion, or burden that can come with taking multiple medications.
Other Study Goal:
The study will also explore whether older adults are willing and able to use the online tool regularly to track medication safety concerns in their daily lives. This includes looking at how comfortable participants feel using the tool and whether they find it helpful for monitoring their medications, symptoms, and concerns.
What Will Happen in the Study:
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)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older adults (≥ 65 years old)
- •Living alone (residing in a single-family home, apartment, or independent senior housing unit with no other co-habitating adults or children; and having been living alone continuously for at least 6 months prior to screening)
- •With subjective or mild cognitive decline (a screening test to confirm)
- •Taking at least five prescribed medications concurrently
- •With suboptimal self-reported medication adherence (a screening test to confirm)
- •Having access to a computer or mobile device and internet service
- •Able to read and speak English
排除标准
- •Having severe cognitive, vision, hearing, or other impairment
- •Unable to use computers or mobile devices
- •Relying on someone else to manage medications
研究组 & 干预措施
HOME-MIND
Participants are trained and perform daily self-monitoring of medication safety events using an online tool with self-reporting forms, an AI-driven educational chatbot, and a personal dashboard for data visualization and sharing.
干预措施: HOME-MIND (Behavioral)
Usual Care
Participants follow routine medical care instructions.
结局指标
主要结局
Medication self-management
时间窗: From enrollment to the end of the study at 3 months, including monthly assessments.
Medication self-management is defined as "the extent to which a patient takes medication as prescribed, including not only the correct dose, frequency and spacing, but also its continued, safe use over time". It is deconstructed into a series of steps a patient must take to safely and effectively take their medications, including filling a prescription, understanding directions for use, organizing a regimen, taking medications, monitoring side effects, and sustaining use over time. In this study, we will measure medication self-management using the 12-item Measure of Drug Self-Management. This tool uses a sum of scores ranging from 0 (poor medication self-management) to 12 (adequate medication self-management). The tool can also be used to categorize patients as having "adequate" drug self-management skills (score of 10 or greater) or "inadequate" drug self-management skills (score of less than 10).
次要结局
- Medication burden(From enrollment to the end of the study at 3 months, it was assessed at baseline and at 3 months.)
研究者
Yun Jiang
Associate Professor
University of Michigan