An Enhanced Medication Monitoring Program
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2010
CompletedFirst Posted
Study publicly available on registry
April 16, 2010
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedNovember 8, 2011
November 1, 2011
1.7 years
April 14, 2010
November 7, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
medication adherence
6 months
change in systolic blood pressure
6 months
Secondary Outcomes (2)
change in self-efficacy about taking medication
6 months
self-reported medication taking
6 months
Study Arms (2)
MedMinder System
OTHERMedMinder System - deactivated
OTHERInterventions
Participants will receive a fully activated reminder unit as well as at least one call per month from a counselor.
Participants will receive a one-way reminder unit that will remotely transit information on medication adherence
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- receives personal help or reminders to take medication
- has moderate to severe dementia (MMSE score\<18)
- has severe hearing or vision deficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedMinder Systems Inc.lead
- Narrows Institute for Biomedical Researchcollaborator
Study Sites (1)
VA New York Harbor Healthcare System
New York, New York, 10010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2010
First Posted
April 16, 2010
Study Start
September 1, 2011
Primary Completion
May 1, 2013
Study Completion
June 1, 2013
Last Updated
November 8, 2011
Record last verified: 2011-11