An Enhanced Medication Monitoring Program

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Medication Adherence
• Intervention / Treatment: Device: MedMinder System; Device: MedMinder System - deactivated

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sundar Natarajan, MD, M.Sc; Phone Number: 212-951-3395; Email: sundar.natarajan@va.gov

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • Recruiting
      • VA New York Harbor Healthcare System
      • Contact: Sundar Natarajan, MD, M.Sc.; Phone Number: 212-951-3395; Email: sundar.natarajan@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: MedMinder System	Device: MedMinder System; Participants will receive a fully activated reminder unit as well as at least one call per month from a counselor.
Other: MedMinder System - deactivated	Device: MedMinder System - deactivated; Participants will receive a one-way reminder unit that will remotely transit information on medication adherence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
medication adherence	6 months
change in systolic blood pressure	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
change in self-efficacy about taking medication	6 months
self-reported medication taking	6 months

Collaborators and Investigators

• Sponsor: MedMinder Systems Inc.
• Collaborators: Narrows Institute for Biomedical Research

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: April 14, 2010
• First Submitted That Met QC Criteria: April 15, 2010
• First Posted (Estimate): April 16, 2010

Study Record Updates

• Last Update Posted (Estimate): November 8, 2011
• Last Update Submitted That Met QC Criteria: November 7, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 1R43HL097395-01A1 (U.S. NIH Grant/Contract)