Older Adults (65 Years and Older)HOME-MINDNCT07659548
Home-based Monitoring & Enabled Medication Independence With New Digital Tools
A study testing HOME-MIND in people with Older Adults (65 Years and Older) and Living Alone, run by University of Michigan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Adults (65 Years and Older), Living Alone, Mild Cognitive Decline
- What is being tested?
- HOME-MIND
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Having severe cognitive, vision, hearing, or other impairment
- Unable to use computers or mobile devices
- Relying on someone else to manage medications
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Older Adults (65 Years and Older), Living Alone, Mild Cognitive Decline, Polypharmacy (People Under Treatment With 5 or More Drugs)
- Being tested
- HOME-MIND
- Keywords
- older adults, mild cognitive decline, medication self-management, symptom self-tracking, online digital tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOME-MINDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: HOME-MIND |
| Usual Care | No intervention | Participants follow routine medical care instructions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, 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).
Measured: From enrollment to the end of the study at 3 months, including monthly assessments.
Secondary outcomes (1)
Medication burden
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).
Measured: From enrollment to the end of the study at 3 months, it was assessed at baseline and at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults (65 Years and Older)Studies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Arizona State University
- Responsible party
- Principal investigator, Yun Jiang, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659548
- Sponsor's protocol ID
- HUM00289265
- Other IDs
- 1P30AG086561
- Acronym
- HOME-MIND
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We may be able to share aggregated participant data.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technological Innovation to Support Medication Safety and Optimization in Older Adults Living Alone With Cognitive Decline
- ClinicalTrials.gov ID
- NCT07659548
- Acronym / sponsor ID
- HOME-MIND / HUM00289265
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Arizona State University
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| HOME-MIND | Experimental | Behavioral: HOME-MINDParticipants 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 | No intervention | –Participants follow routine medical care instructions. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- Having severe cognitive, vision, hearing, or other impairment
- Unable to use computers or mobile devices
- Relying on someone else to manage medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOME-MINDHOME-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. | Behavioural | HOME-MIND |
Primary outcome
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, 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).
1 secondary outcome
Medication burden
Time frame: From enrollment to the end of the study at 3 months, it was assessed at baseline and at 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Undecided. We may be able to share aggregated participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing HOME-MIND in people with Older Adults (65 Years and Older) and Living Alone, run by University of Michigan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun Jiang, PhD, MS, RN (734-763-3705, UNSN-Jiang-Study@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication self-management (time frame: From enrollment to the end of the study at 3 months, including monthly assessments.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.