Home-based Monitoring & Enabled Medication Independence With New Digital Tools (HOME-MIND)
Technological Innovation to Support Medication Safety and Optimization in Older Adults Living Alone With Cognitive Decline
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Yun Jiang, PhD, MS, RN
- Telefonní číslo: 734-763-3705
- E-mail: UNSN-Jiang-Study@med.umich.edu
Studijní záloha kontaktů
- Jméno: Chelsea Frank, BS, MBA
- Telefonní číslo: 734-647-4710
- E-mail: UNSN-Jiang-Study@med.umich.edu
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having severe cognitive, vision, hearing, or other impairment
- Unable to use computers or mobile devices
- Relying on someone else to manage medications
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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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 facilitate health communication.
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Žádný zásah: Usual Care
Participants follow routine medical care instructions.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Medication self-management
Časové okno: From enrollment to the end of the study at 3 months, including monthly assessments.
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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, medication self-management will be measured using the 12-item Measure of Drug Self-Management.
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From enrollment to the end of the study at 3 months, including monthly assessments.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Medication burden
Časové okno: From enrollment to the end of the study at 3 months, it was assessed at baseline and at 3 months.
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Assessing patient-perceived medication burden is the first step in medication optimization and evaluates how complex dosing regimens, side effects, out-of-pocket costs, and daily lifestyle disruptions affect a patient's quality of life, helping determine patients' attitudes toward and experiences with medications.
In this study, perceived medication burden is measured using the 41-item Living with Medicines Questionnaire (LMQ-3), which includes eight domains: relationships with health professionals, practicalities, interferences, effectiveness, side effects, concerns, cost, and autonomy.
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From enrollment to the end of the study at 3 months, it was assessed at baseline and at 3 months.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Patient activation
Časové okno: From enrollment to the end of the study at 3 months, including monthly assessments.
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Patient activation refers to an individual's confidence, knowledge, motivation, and skills integral to managing one's own health and healthcare, measured by the 13-item Patient Activation Measure (PAM).
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From enrollment to the end of the study at 3 months, including monthly assessments.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- HUM00289265
- 1P30AG086561 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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