An Enhanced Medication Monitoring Program

NCT ID: NCT01105104

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Medication Adherence Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MedMinder System

Group Type OTHER

MedMinder System

Intervention Type DEVICE

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

MedMinder System - deactivated

Group Type OTHER

MedMinder System - deactivated

Intervention Type DEVICE

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

Interventions

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MedMinder System

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

Intervention Type DEVICE

MedMinder System - deactivated

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Narrows Institute for Biomedical Research

OTHER

Sponsor Role collaborator

MedMinder Systems Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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VA New York Harbor Healthcare System

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sundar Natarajan, MD, M.Sc

Role: CONTACT

212-951-3395

Facility Contacts

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Sundar Natarajan, MD, M.Sc.

Role: primary

212-951-3395

Other Identifiers

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1R43HL097395-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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