Preventing Medication Mismanagement in People Living With Dementia
ConditionDementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHiDO Technologies
About this trial
The purpose of this research is to learn whether the HiDO-ALZ device can improve medication compliance and health outcomes in participants with dementia that need to take daily medication.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have a diagnosis of dementia.
They must be prescribed one medication indicated for dementia symptoms such as Aricept, Namenda, or Donepezil, and be prescribed at least one additional medication.
Participants must have an active study partner that is willing to be enrolled into the study and willing to receive messages and alerts from the HiDO-ALZ system if medications are missed. The study partner must also agree to complete surveys about the participant's ongoing health.
Participants must be willing to allow research staff to enter their homes to install the HiDO-ALZ device and to complete study activities.
Disqualifiers
The inability to demonstrate capacity to consent or assent as determined by the Capacity Assessment Checklist.
Individuals who do not have a study partner/caregiver (e.g., spouse, adult child) to complete questionnaires.
Participants with MoCA scores below 15 will be excluded as they may not be able to use the device independently.
Participants who are unable or unwilling to complete the cognitive testing or unwilling to complete the blood tests.
Trial design
Design model
Parallel
Treatments tested in this trial
HiDO HomeCareSystem
DeviceParticipants randomized to the intervention arm will receive and be trained on the HiDO HCS Device and will have medication dispensed via this technology.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: HiDO HomeCare SystemActive comparator 1 intervention
Group B: Standard Medication ManagementNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change From Baseline to 12 months in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Total Score
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a standardized assessment used to evaluate the severity of cognitive dysfunction. The total score is derived from multiple cognitive domains, including memory, language, praxis, and orientation. Change from baseline to the specified assessment timepoint will be analyzed, with higher scores indicating greater cognitive impairment.
Time frame
baseline and 12-months2
Change From Baseline to 12 months for Everyday Cognition (ECog) Total Score
Everyday Cognition (ECog) is a validated questionnaire used to assess cognitively relevant functional abilities in older adults across multiple domains. The ECog total score will be calculated based on participant responses, with higher scores indicating greater perceived cognitive decline. Change from baseline to the specified assessment timepoint will be analyzed.
Time frame
Baesline, 4, 8, and 12 month timepointsSponsors and contacts
Click on the lead sponsor to view all of their trials.
HiDO Technologies
Lead sponsor
University of California, Davis
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov