Medication Management Among Individuals With Neurodevelopmental Disabilities (M-MIND)
研究概览
详细说明
In this study, an application will be iteratively developed and tested using RL-adaptive support for young adults with disabilities, with the goal to promote the transition to independent self-medication administration among young adults with cerebral palsy and spina bifida.
Stochastic mathematical models of how individuals with varying levels of executive function and psychomotor skills will respond to the interventions (i.e. the different types and formats of messages) of the RL-adaptive support will be developed.
Up to 6 dyads of individuals with disabilities and their caregivers were intended to be recruited to collaborate in defining the features and content of the RL-adaptive support. The investigators recruited 3 dyads.
The steps in developing the RL-adaptive support include having the dyads use for approximately 6 weeks each:
- young adult uses an electronic medication pillbox that sends its pillbox openings within one hour of opening to the research team,
- young adult uses the electronic medication pillbox + both use a commercially available medication reminder app + caregiver uses a pillbox opening notification app, and
- young adult uses the electronic medication pillbox + the RL-adaptive support including push notifications in the form of text messages + caregiver uses the pillbox opening notification app
The goal was to reduce the number of caregiver prompts necessary for the medication pillbox to be opened. Using these data, the number and type of prompts necessary for the caregiver to open the electronic pillbox can be determined. In case the young adult does not open the electronic pillbox within two hours, the caregiver will be notified so that pills are not missed. In each step, the useful features of the system will be determined via qualitative and quantitative feedback with specific suggestions about how to improve this supportive system.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
For young adult:
- Diagnosed with cerebral palsy or spina bifida and previously enrolled in HUM00081812
- Age 18-26 years-old
- Having mild-moderate cognition based on consultation with the investigators and the results of the following tests: iBRIEF Metacognition index T-Score, CVLT List A Free Recall T Score, ReyO Organization T-Score, PPVT Scaled Score, Tower Scaled Score, TRAQ question 4: Do participants take medications correctly and on their own?
- Having adequate physical dexterity (to be able to open a pill box and use an iPad/tablet)
- Taking two or more routine oral medicines in pill formulation
- Being able to take capsules or tablets
- Still living at home with their parent/legal guardian
- Have Wi-Fi/Internet access at home
For parent/caregiver:
- Being the parent/legal guardian of a person with aforementioned disability
- Owning a cell phone
- Have Wi-Fi/Internet access at home
Exclusion Criteria:
• Those who do not fulfill the inclusion criteria will be excluded from the study
学习计划
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：RL-adaptive application
Dyad is comprised of individual with disability (spina bifida or cerebral palsy) and the respective parent/legal guardian (also referred to as caregivers). Young adult will use the RL-adaptive support application that the investigators are developing to help manage medications. |
Up to 6 dyads of individuals with disabilities and their caregivers will be recruited to collaborate in defining the features and content of the RL-adaptive support. The steps in developing the RL-adaptive support include having the dyads use for approximately 6 weeks each:
The goal is to reduce the number of caregiver prompts necessary for the medication pillbox to be opened. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Prefer to continue to use RL-adaptive support after study is over
大体时间：at least 18 weeks after beginning study
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Qualitative feedback
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at least 18 weeks after beginning study
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Usefulness of the aspects of the RL-adaptive support
大体时间：End of each phase, which lasts approximately 6 weeks
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Qualitative feedback
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End of each phase, which lasts approximately 6 weeks
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Most and least helpful aspects of RL-adaptive support application
大体时间：End of each phase, which lasts approximately 6 weeks
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Qualitative feedback
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End of each phase, which lasts approximately 6 weeks
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Ease of use of RL-adaptive support application
大体时间：End of each phase, which lasts approximately 6 weeks
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Qualitative feedback
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End of each phase, which lasts approximately 6 weeks
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合作者和调查者
调查人员
- 首席研究员：Karen B Farris, PhD、Professor and Chair, Department of Clinical Pharmacy, University of Michigan College of Pharmacy
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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