Home-based Monitoring & Enabled Medication Independence With New Digital Tools

Официальное название

Technological Innovation to Support Medication Safety and Optimization in Older Adults Living Alone With Cognitive Decline

Обзор

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.

Подробное описание

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:

Participants will be randomly assigned - like flipping a coin - to one of two groups:

Group 1: Online Tool Group:

Participants in this group will receive training on how to use the online self-monitoring tool. They will use the tool for 3 months to track medication-related problems, symptoms, side effects, or other concerns while at home.

During this time, participants will also (1) receive monthly check-ins about their experience using the tool; (2) get educational information and suggestions based on what they report; (3) receive summaries of their medication self-monitoring journey; and (4) be able to interact with an online chatbot about their medication-related concerns.

Group 2: Usual Care Group:

Participants in this group will continue following their regular medical care and medication instructions for the first 3 months.

During this time, they will complete monthly follow-up assessments with the study team. After the first 3 months, they will have the opportunity to use the online self-monitoring tool for 1 month.

Overall Purpose:

By comparing these two groups, researchers hope to learn whether the online tool is useful, easy to use, and helpful for supporting safer medication management among older adults living alone with memory concerns or mild thinking changes.

Вмешательства

• Поведенческое HOME-MIND
  HOME-MIND aims to improve medication self-management and reduce perceived medication burden in older adults living alone with subjective or mild cognitive decline. This 3-month intervention includes daily technology-enabled self-monitoring of medication safety events or experiences, personalized educational support informed by self-monitoring data, visualizations and summaries of self-monitoring data on a personal dashboard, and sharing self-monitoring summaries with health care providers to fac

Первичные конечные точки

• Medication self-management [Срок оценки: From enrollment to the end of the study at 3 months, including monthly assessments.]

Вторичные конечные точки (1)

• Medication burden [Срок оценки: From enrollment to the end of the study at 3 months, it was assessed at baseline and at 3 months.]

Критерии участия

Критерии включения

• Older adults (≥ 65 years old)
• Living alone (in a non-institutional setting without others)
• 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

Критерии исключения

• Having severe cognitive, vision, hearing, or other impairment
• Unable to use computers or mobile devices
• Relying on someone else to manage medications

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07659548 · HUM00289265 · 1P30AG086561

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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