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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Yun Jiang, PhD, MS, RN
- 電話番号：734-763-3705
- メール：UNSN-Jiang-Study@med.umich.edu
研究連絡先のバックアップ
- 名前：Chelsea Frank, BS, MBA
- 電話番号：734-647-4710
- メール：UNSN-Jiang-Study@med.umich.edu
参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having severe cognitive, vision, hearing, or other impairment
- Unable to use computers or mobile devices
- Relying on someone else to manage medications
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：Usual Care
Participants follow routine medical care instructions.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Medication self-management
時間枠：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).
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From enrollment to the end of the study at 3 months, including monthly assessments.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Medication burden
時間枠：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 Version 3 (LMQ-3), which includes eight domains: relationships with health professionals, practicalities, interferences, effectiveness, side effects, concerns, cost, and autonomy.
Total/composite scores for Likert-type statements range from 41 to 205; higher scores indicate worse experiences of medicine use (higher medicine burden).
Additionally, total scores can be categorized as: No burden at all (41-73); Minimal burden (74-106); Moderate burden (107-139); High burden (140-172); and Extremely high burden (173-205).
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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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient activation
時間枠：From enrollment to the end of the study at 3 months, including monthly assessments.
|
Patient activation refers to an individual's confidence, knowledge, motivation, and skills needed to manage their own health and healthcare, as measured by the 13-item Patient Activation Measure (PAM).
Insignia Health's proprietary survey scoring algorithm produces a PAM Score along an empirical, interval-level scale from 0-100 that correlates to one of four levels of patient activation.
PAM Levels 1 and 2 indicate lower patient activation, while PAM Levels 3 and 4 indicate higher patient activation.
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From enrollment to the end of the study at 3 months, including monthly assessments.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- HUM00289265
- 1P30AG086561 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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