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

NCT07659548 | Not Yet Recruiting

• 2 other identifiers: HUM002892651P30AG086561
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Older Adults (65 Years and Older); Living Alone; Mild Cognitive Decline; Polypharmacy (People Under Treatment With 5 or More Drugs)

Keywords

older adults; mild cognitive decline; medication self-management; symptom self-tracking; online digital tool

Outcome Measures

Primary Outcomes (1)

• Medication self-management

  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 Outcomes (1)

• Medication burden

  From enrollment to the end of the study at 3 months, it was assessed at baseline and at 3 months.

Other Outcomes (1)

• Patient activation

  From enrollment to the end of the study at 3 months, including monthly assessments.

Study Arms (2)

HOME-MIND

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Participants follow routine medical care instructions.

Interventions

HOME-MIND BEHAVIORAL

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.

HOME-MIND

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator
• Arizona State University: collaborator

Central Study Contacts

Yun Jiang, PhD, MS, RN

CONTACT

734-763-3705; UNSN-Jiang-Study@med.umich.edu

Chelsea Frank, BS, MBA

CONTACT

734-647-4710; UNSN-Jiang-Study@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The 3-month (1:1 parallel) RCT has two arms: * HOME-MIND intervention: 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. * Usual Care Control: participants follow routine medical care instructions.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06