SBIR-STTR Award

Ensuring medication ingestion without altering existing medication regimen
Award last edited on: 4/12/2023

Sponsored Program
SBIR
Awarding Agency
NIH : NIA
Total Award Amount
$496,388
Award Phase
1
Solicitation Topic Code
866
Principal Investigator
Tony C Carnes

Company Information

Etectrx Inc

747 S W 2nd Avenue Suite 365 T Imb 24
Gainesville, FL 32601
   (352) 262-8054
   N/A
   www.etectrx.com
Location: Single
Congr. District: 03
County: Alachua

Phase I

Contract Number: 1R43AG073011-01A1
Start Date: 9/15/2022    Completed: 12/31/2023
Phase I year
2022
Phase I Amount
$496,388
In the US, approximately 835, 000 persons are living in assisted living facilities with more than 50 percent of those having some form of dementia or cognitive impairment. The average cost of those living in assisted living facilities is $4050 per month, with memory care increasing this cost by an average of $1250 per month. Advancements in medications such as Donepezil, Galantamine, and Rivastigmine have been shown to help manage and even reverse some dementia symptoms, but these medications are not effective unless they are taken on a regular basis. Slowing the progression of dementia can prolong the ability of persons to live independently. While the use of blister packs and pill boxes are designed to help ensure that patients are taking medications on a prescribed basis, these technologies report intent to ingest and often do not provide any feedback that can be monitored by others outside the home. Given that 53 million US citizens are already past retirement age and that 70 percent will require some form of long-term care in their lifetime, it is clear that the cost of managing this disease will continue to grow unless alternative solutions are put in place. In Phase I of the grant we propose to enhance the FDA cleared ID-Cap system by building a home-based ingestion monitoring system that can detect medication ingestions within the home instead of requiring a user to wear an ID-Cap Reader. The ID-Cap system is currently designed to detect ingestions by sending out a small radio signal from within a person's stomach when an ID-Cap is ingested. The existing system detects these signals using a lanyard-style reader. As these patients may forget to use the reader, we propose to create a new reader design that can "hear" the ingestion from across the room using improvements in antenna design and signal processing. To ensure detection if a patient takes their medication in different rooms, a mesh network of readers placed in the home can ensure that the signal is detected and forwarded to the existing cloud-based monitoring platform. In Phase I, we propose two specific aims. Aim 1 - Create a prototype wall-plug based networked reader Leveraging our experience developing the existing ID-Cap wearable reader, we will design a new generation reader that will be able to detect ingestions within a room instead of requiring the user to wear a reader. The captured signals will be forwarded across a mesh network to a base station that ensures delivery to a cloud repository so that care providers can monitor actual ingestion events and intervene if needed. Aim 2 - Evaluate effectiveness and acceptability of the new system in 3 simulated environments Using the prototyped base station and networked readers, we will evaluate the ability to detect signals in three different home configurations. This feedback will help inform installation configuration designs regarding the optimal number and placement of readers. Interviews with persons with dementia and their caregivers will inform acceptability.

Public Health Relevance Statement:
NARRATIVE For many of our aging population, remembering to take medication can be difficult. Non-adherence to a prescribed medication regimen is a leading cause of relocation to a costly assisted living facility. A multitude of products have been developed to try to address this issue, including pill boxes and blister packs, but often pills removed from containers are not ingested. In this proposal we build a network of sensors that can be placed throughout the home that capture signals from ingested medications that have been encapsulated in ID-Capsules. This solution forwards the captured ingestion information to a monitoring facility that can intervene when medications are under or over dosed. Terms: Accidents; Age; ages; Elderly; advanced age; elders; geriatric; late life; later life; older adult; older person; senior citizen; Alzheimer's Disease; AD dementia; Alzheimer; Alzheimer Type Dementia; Alzheimer disease; Alzheimer sclerosis; Alzheimer syndrome; Alzheimer's; Alzheimer's disease dementia; Alzheimers Dementia; Alzheimers disease; Primary Senile Degenerative Dementia; dementia of the Alzheimer type; primary degenerative dementia; senile dementia of the Alzheimer type; Bulla; Bleb; Blister; Bullous Lesion; Vesication; capsule; Capsules; Chronic Disease; Chronic Illness; chronic disorder; Communication; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Environment; Feedback; Galantamine; Galantamin; Galanthamine; Lycoremine; Grant; Health care facility; Health Facilities; Healthcare Facility; care facilities; Hearing; Interview; Long-Term Care; extended care; longterm care; Persons; Neck; nursing home; Nursing Homes; Patients; Drug Prescribing; medication prescription; prescribed medication; Drug Prescriptions; Retirement; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Signal Transduction; gastric; Stomach; Technology; Time; Generations; Caregivers; Care Givers; Caring; base; sensor; improved; Encapsulated; Phase; Ensure; Ingestion; Individual; Early Intervention; Cognitive Disturbance; Cognitive Impairment; Cognitive decline; Cognitive function abnormal; Disturbance in cognition; cognitive dysfunction; cognitive loss; Impaired cognition; Disorder Management; Disease Management; Frequencies; Event; System; Amentia; Dementia; donepezil; experience; monitoring device; rivastigmine; Structure; Participant; Reporting; assisted living; assistive living; assistive living facilities; Assisted Living Facilities; depository; repository; Intervention Strategies; interventional strategy; Intervention; pill; Radio; Address; Dose; Symptoms; Adherence; Data; Detection; Reader; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Monitor; Development; developmental; medication compliance; drug adherence; drug compliance; medication adherence; cost; design; designing; Network-based; usability; prototype; aging population; aged population; population aging; Regimen; mobile application; mobile app; mobile device application; signal processing; cloud based; radio frequency; radiofrequency; care providers; primary care provider; care costs; memory care; COVID-19 pandemic; COVID crisis; COVID epidemic; COVID pandemic; COVID-19 crisis; COVID-19 epidemic; COVID-19 global health crisis; COVID-19 global pandemic; COVID-19 health crisis; COVID-19 public health crisis; COVID19 crisis; COVID19 epidemic; COVID19 global health crisis; COVID19 global pandemic; COVID19 health crisis; COVID19 pandemic; COVID19 public health crisis; SARS-CoV-2 epidemic; SARS-CoV-2 global health crisis; SARS-CoV-2 global pandemic; SARS-CoV-2 pandemic; SARS-CoV2 epidemic; SARS-CoV2 pandemic; SARS-coronavirus-2 epidemic; SARS-coronavirus-2 pandemic; Severe Acute Respiratory Syndrome CoV 2 epidemic; Severe Acute Respiratory Syndrome CoV 2 pandemic; Severe acute respiratory syndrome coronavirus 2 epidemic; Severe acute respiratory syndrome coronavirus 2 pandemic; corona virus disease 2019 epidemic; corona virus disease 2019 pandemic; coronavirus disease 2019 crisis; coronavirus disease 2019 epidemic; coronavirus disease 2019 global health crisis; coronavirus disease 2019 global pandemic; coronavirus disease 2019 health crisis; coronavirus disease 2019 pandemic; coronavirus disease 2019 public health crisis; coronavirus disease crisis; coronavirus disease epidemic; coronavirus disease pandemic; coronavirus disease-19 global pandemic; coronavirus disease-19 pandemic; severe acute respiratory syndrome coronavirus 2 global health crisis; severe acute respiratory syndrome coronavirus 2 global pandemic; effectiveness evaluation; assess effectiveness; determine effectiveness; effectiveness assessment; evaluate effectiveness; remote monitoring; Home

Phase II

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