Home-based Monitoring & Enabled Medication Independence With New Digital Tools (HOME-MIND)

June 15, 2026 updated by: Yun Jiang, University of Michigan

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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 facilitate health communication.
No Intervention: Usual Care
Participants follow routine medical care instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication self-management
Time Frame: 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, medication self-management will be measured using the 12-item Measure of Drug Self-Management.
From enrollment to the end of the study at 3 months, including monthly assessments.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication burden
Time Frame: From enrollment to the end of the study at 3 months, it was assessed at baseline and at 3 months.
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.
From enrollment to the end of the study at 3 months, it was assessed at baseline and at 3 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient activation
Time Frame: 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 integral to managing one's own health and healthcare, measured by the 13-item Patient Activation Measure (PAM).
From enrollment to the end of the study at 3 months, including monthly assessments.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute on Aging (NIA)
Arizona State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUM00289265
  • 1P30AG086561 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We may be able to share aggregated participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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