DementiaNCT07872072
HomeCare Medication Management for People With Dementia
A study testing HomeCare in people with Dementia and Alzheimer's Disease and Related Dementias, run by HiDO Technologies at 1 site in United States.
Trial summary
This study will evaluate whether the HomeCare medication management system can improve medication adherence and related outcomes for adults age 65 and older living with dementia, Alzheimer's disease, or related dementias. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Alzheimer's Disease and Related Dementias
- What is being tested?
- HomeCare
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 May 2027
- 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
- Age 65 years or older.
- Living with dementia, Alzheimer's Disease, or Alzheimer's Disease Related Dementias (AD/ADRD) according to standardized diagnostic criteria.
- Capable of providing informed consent or have a legally authorized representative available to consent on their behalf.
- Access to a smartphone, tablet, or computer with internet connectivity. Able to communicate in either English or Spanish.
Who cannot join
- Significant comorbidities or medical conditions that could interfere with participation or severe cognitive function.
- History of severe psychiatric illness or substance abuse disorder.
- Recent participation in other clinical trials targeting cognition or dementia.
- Unwillingness or inability to comply with study procedures.
- Residence in a long-term care facility or institutional setting that may limit access to the home-based study intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, Davis
Davis, California, 95618-6153
Sarah Tomaszewski-Farias, PhD, 916-734-6442, farias@ucdavis.edu
About this study
Official title: Behavioral Shifts in Dementia Patients Using Novel Pharmacy Home Robotics: A Cost-Effective Approach to Aging in Place
This study will evaluate whether the HomeCare medication management system can improve medication adherence and related outcomes for adults age 65 and older living with dementia, Alzheimer's disease, or related dementias.
HomeCare is an internet-connected medication management device that can automate medication dispensing, monitor medication use, and provide alerts to caregivers. The system is integrated with a Pharmacy Distribution System designed to track medications from pharmacy delivery through use in the home.
A total of 120 participants with dementia will be randomly assigned to one of two groups. One group will use the HomeCare system, while the other group will continue using standard medication management methods, such as pill bottles or blister packs. Participants will be followed for 12 months. The main outcome is medication adherence. The study will also examine hospitalizations and emergency room visits, cognitive function, caregiver burden, quality of life, satisfaction, and changes in medication-management behavior. Caregivers will also participate in surveys and study assessments. The study is intended to determine whether HomeCare can improve medication management and support both people living with dementia and their caregivers.
Read the detailed description
This is a two-arm randomized controlled trial evaluating the HomeCare Pharmacy Distribution System for medication management among adults living with dementia, Alzheimer's disease, or Alzheimer's disease-related dementias.
The study will enroll 120 participants with dementia and their caregivers. Participants will be randomized to either the HomeCare intervention group or a standard-care control group. Participants assigned to the intervention group will use the HomeCare system for medication management. The system is designed to automate medication dispensing, monitor medication adherence, document medication-use patterns, and provide real-time alerts to caregivers. Participants assigned to the control group will continue using traditional medication-management methods, including pill bottles or blister packs.
The primary objective is to evaluate medication adherence over 12 months. Medication adherence will be assessed using the Medication Adherence Rating Scale and Proportion of Days Covered, together with medication-use information collected through the HomeCare system for participants in the intervention group.
Additional outcomes will include hospitalizations and emergency room visits, cognitive function, caregiver burden, quality of life, satisfaction, and behavioral changes related to medication management. Cognitive function will be assessed using the Everyday Cognition assessment at baseline, 6 months, and 12 months. Caregiver burden and quality-of-life measures will also be collected during the study.
Caregivers in both study groups will receive study-related training and will complete surveys and other assessments related to caregiver burden, quality of life, medication-management activities, and their experience supporting the participant.
Participants will be age 65 or older and will have dementia, Alzheimer's disease, or a related dementia. The study will be conducted in collaboration with the University of California, Davis. Participants will be followed for 12 months. Study procedures include regular participant and caregiver follow-up, monitoring for device-related issues and adverse events, and collection of study outcome data.
Safety procedures include participant and caregiver training, regular study-team contact, secure handling of study data, and access to backup medication supplies if technical problems with the HomeCare device occur. Participants may withdraw from the study at any time.
- Being tested
- HomeCare
- Keywords
- Medication Adherence, HomeCare, Medication Management, Pharmacy Distribution System, Caregiver Burden, Cognitive Function, Hospitalization, Quality of Life, Video Direct Observed Therapy, Older Adults
- Medical subject headings
- Dementia, Alzheimer Disease, Medication Adherence, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HomeCareDevice
An automated, secure, AI driven medication delivery and observation platform to maximize therapy compliance, provide continuous medication monitoring and outcomes for individuals impacted by AD/ADRD.
| Study group | Role | What they receive |
|---|---|---|
| HomeCare System (Intervention Group) | Experimental | Participants in this arm will use the HomeCare system for medication management. The HomeCare system automates medication reminders, records medication intake, and provides caregivers with real-time alerts about adherence and patient behaviors. The system integrates medication dispensing, adherence monitoring, Video Directly Observed Therapy (VDOT), intervention support, and prescription information over the 12-month study period. Receives: Device: HomeCare |
| Standard of Care (Control Group) | No intervention | Participants in this arm will follow the current standard of care for medication management using manual methods such as pill bottles or blister packs. Caregivers or participants will manually track medication adherence and manage medication schedules without technological assistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Medication adherence will be assessed using the Medication Adherence Rating Scale (MARS) and Proportion of Days Covered (PDC). The HomeCare system will track adherence through its automated logging of medication usage and AI-powered monitoring algorithms.
Measured: 12 months
Secondary outcomes (3)
Incidence of Hospitalizations
The frequency of hospitalizations and emergency room visits will be recorded and compared between the intervention and control groups.
Measured: 12 months
ECOG Cognitive Assessment
The ECOG assessment will measure changes in cognitive function over the study period.
Measured: Baseline, 6 months, 12 months
Zarit Burden Interview (ZBI) Score
Caregiver burden will be evaluated using the Zarit Burden Interview, a validated tool for assessing the psychological impact on caregivers.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HiDO Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), University of California, Davis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872072
- Sponsor's protocol ID
- R44AG097250
- Other IDs
- R44AG097250
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Shifts in Dementia Patients Using Novel Pharmacy Home Robotics: A Cost-Effective Approach to Aging in Place
- ClinicalTrials.gov ID
- NCT07872072
- Acronym / sponsor ID
- R44AG097250
- Keywords
- Medication Adherence, HomeCare, Medication Management, Pharmacy Distribution System, Caregiver Burden, Cognitive Function, Hospitalization, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- HiDO TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), University of California, Davis
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 Oct 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 study will evaluate whether the HomeCare medication management system can improve medication adherence and related outcomes for adults age 65 and older living with dementia, Alzheimer's disease, or related dementias.
HomeCare is an internet-connected medication management device that can automate medication dispensing, monitor medication use, and provide alerts to caregivers. The system is integrated with a Pharmacy Distribution System designed to track medications from pharmacy delivery through use in the home.
A total of 120 participants with dementia will be randomly assigned to one of two groups. One group will use the HomeCare system, while the other group will continue using standard medication management methods, such as pill bottles or blister packs. Participants will be followed for 12 months. The main outcome is medication adherence. The study will also examine hospitalizations and emergency room visits, cognitive function, caregiver burden, quality of life, satisfaction, and changes in medication-management behavior. Caregivers will also participate in surveys and study assessments. The study is intended to determine whether HomeCare can improve medication management and support both people living with dementia and their caregivers.
Detailed description
This is a two-arm randomized controlled trial evaluating the HomeCare Pharmacy Distribution System for medication management among adults living with dementia, Alzheimer's disease, or Alzheimer's disease-related dementias.
The study will enroll 120 participants with dementia and their caregivers. Participants will be randomized to either the HomeCare intervention group or a standard-care control group. Participants assigned to the intervention group will use the HomeCare system for medication management. The system is designed to automate medication dispensing, monitor medication adherence, document medication-use patterns, and provide real-time alerts to caregivers. Participants assigned to the control group will continue using traditional medication-management methods, including pill bottles or blister packs.
The primary objective is to evaluate medication adherence over 12 months. Medication adherence will be assessed using the Medication Adherence Rating Scale and Proportion of Days Covered, together with medication-use information collected through the HomeCare system for participants in the intervention group.
Additional outcomes will include hospitalizations and emergency room visits, cognitive function, caregiver burden, quality of life, satisfaction, and behavioral changes related to medication management. Cognitive function will be assessed using the Everyday Cognition assessment at baseline, 6 months, and 12 months. Caregiver burden and quality-of-life measures will also be collected during the study.
Caregivers in both study groups will receive study-related training and will complete surveys and other assessments related to caregiver burden, quality of life, medication-management activities, and their experience supporting the participant.
Participants will be age 65 or older and will have dementia, Alzheimer's disease, or a related dementia. The study will be conducted in collaboration with the University of California, Davis. Participants will be followed for 12 months. Study procedures include regular participant and caregiver follow-up, monitoring for device-related issues and adverse events, and collection of study outcome data.
Safety procedures include participant and caregiver training, regular study-team contact, secure handling of study data, and access to backup medication supplies if technical problems with the HomeCare device occur. Participants may withdraw from the study at any time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HomeCare System (Intervention Group) | Experimental | Device: HomeCareParticipants in this arm will use the HomeCare system for medication management. The HomeCare system automates medication reminders, records medication intake, and provides caregivers with real-time alerts about adherence and patient behaviors. The system integrates medication dispensing, adherence monitoring, Video Directly Observed Therapy (VDOT), intervention support, and prescription information over the 12-month study period. |
| Standard of Care (Control Group) | No intervention | –Participants in this arm will follow the current standard of care for medication management using manual methods such as pill bottles or blister packs. Caregivers or participants will manually track medication adherence and manage medication schedules without technological assistance. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 years or older.
- Living with dementia, Alzheimer's Disease, or Alzheimer's Disease Related Dementias (AD/ADRD) according to standardized diagnostic criteria.
- Capable of providing informed consent or have a legally authorized representative available to consent on their behalf.
- Access to a smartphone, tablet, or computer with internet connectivity. Able to communicate in either English or Spanish.
Key exclusion criteria (5 listed)
- Significant comorbidities or medical conditions that could interfere with participation or severe cognitive function.
- History of severe psychiatric illness or substance abuse disorder.
- Recent participation in other clinical trials targeting cognition or dementia.
- Unwillingness or inability to comply with study procedures.
- Residence in a long-term care facility or institutional setting that may limit access to the home-based study intervention.
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 |
|---|---|---|
| HomeCareAn automated, secure, AI driven medication delivery and observation platform to maximize therapy compliance, provide continuous medication monitoring and outcomes for individuals impacted by AD/ADRD. | Device | HomeCare System (Intervention Group) |
Primary outcome
Medication Adherence
Time frame: 12 months
Medication adherence will be assessed using the Medication Adherence Rating Scale (MARS) and Proportion of Days Covered (PDC). The HomeCare system will track adherence through its automated logging of medication usage and AI-powered monitoring algorithms.
3 secondary outcomes
Incidence of Hospitalizations
Time frame: 12 months
ECOG Cognitive Assessment
Time frame: Baseline, 6 months, 12 months
Zarit Burden Interview (ZBI) Score
Time frame: Baseline, 6 months, 12 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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HomeCare in people with Dementia and Alzheimer's Disease and Related Dementias, run by HiDO Technologies at 1 site in United States.
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 4 inclusion and 5 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Charles Gellman, MSHI, MBA (510-813-7224, charles@hidohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: 12 months). 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 13 Oct 2026.