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An Enhanced Medication Monitoring Program

An Enhanced Medication Monitoring Program

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01105104
Enrollment
150
Registered
2010-04-16
Start date
2011-09-30
Completion date
2013-06-30
Last updated
2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Medication Adherence

Brief summary

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 medications 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. 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.

Interventions

DEVICEMedMinder System

Participants will receive a fully activated reminder unit as well as at least one call per month from a counselor.

DEVICEMedMinder System - deactivated

Participants will receive a one-way reminder unit that will remotely transit information on medication adherence

Sponsors

Narrows Institute for Biomedical Research
CollaboratorOTHER
MedMinder Systems Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* persons aged 55 years and older who are coming in for routine outpatient visits * speaks and reads English * history of high blood pressure * systolic blood pressure ≥ 130 mm Hg * using antihypertensive medication * using 2 or more prescription medications * plans to stay in area for the 9 months of study

Exclusion criteria

* receives personal help or reminders to take medication * has moderate to severe dementia (MMSE score\<18) * has severe hearing or vision deficiency

Design outcomes

Primary

MeasureTime frame
medication adherence6 months
change in systolic blood pressure6 months

Secondary

MeasureTime frame
change in self-efficacy about taking medication6 months
self-reported medication taking6 months

Countries

United States

Contacts

Primary ContactSundar Natarajan, MD, M.Sc
sundar.natarajan@va.gov212-951-3395

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026