An Enhanced Medication Monitoring Program
|ClinicalTrials.gov Identifier: NCT01105104|
Recruitment Status : Unknown
Verified November 2011 by MedMinder Systems Inc..
Recruitment status was: Recruiting
First Posted : April 16, 2010
Last Update Posted : November 8, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Medication Adherence Hypertension||Device: MedMinder System Device: MedMinder System - deactivated||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||An Enhanced Medication Monitoring Program|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||June 2013|
Device: MedMinder System
Participants will receive a fully activated reminder unit as well as at least one call per month from a counselor.
|MedMinder System - deactivated||
Device: MedMinder System - deactivated
Participants will receive a one-way reminder unit that will remotely transit information on medication adherence
- medication adherence [ Time Frame: 6 months ]
- change in systolic blood pressure [ Time Frame: 6 months ]
- change in self-efficacy about taking medication [ Time Frame: 6 months ]
- self-reported medication taking [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105104
|Contact: Sundar Natarajan, MD, M.Scemail@example.com|
|United States, New York|
|VA New York Harbor Healthcare System||Recruiting|
|New York, New York, United States, 10010|
|Contact: Sundar Natarajan, MD, M.Sc. 212-951-3395 firstname.lastname@example.org|