The goal of the Enhanced Medication Management Program (eMMp) being developed by MedMinder Systems, Inc. is to increase the ability of frail elders to adhere to complex medication regimens for chronic conditions. Adherence will facilitate effective self-care and decrease personal and societal costs associated with disease progression and loss of independence. Multiple studies have shown that more frequent personal follow-up is the most effective way to maximize medication adherence, but such personal care is too costly to translate well to real life in a world of limited healthcare resources. Currently available "smart pillboxes" are too expensive, too limited in the number and types of medica- tions delivered, and too technically complex for the large majority of senior citizens. The eMMp is designed to deliver prompts and reminders to the user, to be remotely programmable by caregivers, to allow the option of using pre-filled medication trays, to provide electronic adherence reports to family/caregivers and to provide personalized reinforcing phone calls from professional caregivers, all at a modest cost. The in-home ReMinder will use a familiar pillbox layout (4 doses/day for 7 days) and allow easy removal of medication cups by elderly, rheumatic fingers. Installation will require only an electrical outlet (no modems or dedicated phone lines). Once plugged in, the built-in pager will continuously download remotely programmed visual and/or aural prompts and reminders from a central server (RemoteMind). It will continuously upload the date and time when each medi- cation cup is removed and when weekly refill is carried out, enabling remote adherence monitoring, alerts to caregivers, and follow-up intervention(s) from personal and/or professional caregivers as needed. The hypothesis to be tested in this 2 year SBIR Phase I work plan is that the eMMp will significantly im- prove adherence and clinical outcome (blood pressure control) in a population of frail elderly who are hyper- tensive. Specific aims are: 1) to finalize upgrades to the existing RemoteMind web server and to manufacture and release test 175 ReMinder units, and 2) to conduct a randomized clinical trial (150 hypertensive, elderly volunteers; 3-month run-in period, 6-month intervention period) to test whether the fully activated eMMp (pro- viding in-home prompts and reminders, automated reminder calls, and reinforcing personal calls from a profes- sional caregiver as required) can increase medication adherence by at least 25% and reduce systolic blood pressure by at least 8 mm Hg during the intervention period. Assuming a 10% dropout rate during each phase (run-in and intervention), the trial is expected have 80% power to detect improved medication adherence and 95% power to detect reduced systolic blood pressure. Effects of the intervention on attitudes toward medica- tion, perceived ability to self manage complex medication regimens and unscheduled use of healthcare ser- vices will also be assessed. SBIR Phase II will determine the minimum level of intervention needed to achieve sustained medication adherence and control of blood pressure in a larger group of hypertensive elders.
Public Health Relevance: Project Narrative Although 125 million Americans suffer from at least one chronic condition (high blood pressure, heart failure, diabetes, etc.) and 65% of individuals over 65 suffer from two or more such conditions, an estimated 30-60% of them fail to take their medications at the times and/or doses prescribed. Such medication non-adherence undermines attempts to prevent disease progression, is responsible for an estimated 23% of nursing home admissions, and increases healthcare costs by as much as $100 billion annually. MedMinder's goal is to determine whether its Enhanced Medication Management Program (eMMp) can significantly improve me- dication adherence, resulting in better blood pressure control in a group of frail elderly by enabl- ing cost-effective personalized reinforcement from caregivers.
Public Health Relevance Statement: Project Narrative Although 125 million Americans suffer from at least one chronic condition (high blood pressure, heart failure, diabetes, etc.) and 65% of individuals over 65 suffer from two or more such conditions, an estimated 30-60% of them fail to take their medications at the times and/or doses prescribed. Such medication non-adherence undermines attempts to prevent disease progression, is responsible for an estimated 23% of nursing home admissions, and increases healthcare costs by as much as $100 billion annually. MedMinder's goal is to determine whether its Enhanced Medication Management Program (eMMp) can significantly improve me- dication adherence, resulting in better blood pressure control in a group of frail elderly by enabl- ing cost-effective personalized reinforcement from caregivers.
Project Terms: Abbreviations; Adherence (attribute); Admission activity; Adverse effects; Age-Years; American; Appearance; Area; arm; Assisted Living Facilities; Attitude; Authorization documentation; base; Blinking; Blood Pressure; blood pressure regulation; Boston; Cardiovascular system; Caregivers; cerebrovascular; Charge; Chronic; Clinical; Clinical Nursing; Clinical Trials; Clinical Trials Design; cognitive function; commercialization; Communities; Complex; Contractor; Contracts; Control Groups; cost; cost effective; Databases; Depressed mood; design; Devices; Diabetes Mellitus; Disabled Persons; Disease Progression; Dose; Dropout; Effectiveness; Elderly; Electronics; Elements; Event; Excision; Family; Family Caregiver; Fingers; follow-up; Frail Elderly; Friends; Goals; graphical user interface; group intervention; Health Benefit; Health Care Costs; Health Insurance Portability and Accountability Act; Healthcare; Heart failure; Home environment; Housing; Hypertension; Impaired cognition; improved; Individual; Instruction; Internet; Intervention; intervention effect; intervention program; Intervention Trial; Israel; Life; Literature; Mails; Manufacturer Name; Measures; Medical center; medication compliance; Medication Management; Modems; Monitor; multi-arm study; multiple chronic conditions; Notification; novel; Nurses; Nursing Homes; Online Systems; Outcome; Outcome Measure; Participant; Patient Self-Report; Patients; Pattern; Pharmaceutical Preparations; Pharmacy facility; Phase; Physical Function; Physicians; pill (pharmacologic); Plastics; Play; Plug-in; Population; prevent; primary outcome; Problem Solving; programs; Provider; Psychological reinforcement; public health relevance; Questionnaires; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recruitment Activity; Regimen; Relative (related person); Reporting; Resources; response; Retirement; Role; Running; scale up; Schedule; secondary outcome; Secure; Self Care; Self Efficacy; Self Management; Services; Small Business Innovation Research Grant; Solutions; Specific qualifier value; success; Support System; System; Tail; Technology; Telephone; Testing; Text; Time; Translating; Update; usability; Vendor; Visual; volunteer; War; Work
