New York, New York 10010

  • Hypertension

Purpose:

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.


Criteria:

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 is Available At:


Original ID:

1 R43 HL097395-01A1


NCT ID:

NCT01105104


Secondary ID:


Study Acronym:


Brief Title:

An Enhanced Medication Monitoring Program


Official Title:

An Enhanced Medication Monitoring Program


Overall Status:

Recruiting


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

55 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

MedMinder Systems Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

150


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Sundar Natarajan, MD, M.Sc
212-951-3395
sundar.natarajan@va.gov

Study Dates

Start Date:September 2011
Completion Date:June 2013
Completion Type:Anticipated
Primary Completion Date:May 2013
Primary Completion Type:Anticipated
Verification Date:November 2011
Last Changed Date:November 7, 2011
First Received Date:April 14, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:medication adherence
Time Frame:6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:change in systolic blood pressure
Time Frame:6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:change in self-efficacy about taking medication
Time Frame:6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:self-reported medication taking
Time Frame:6 months
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:MedMinder System - deactivated
Description:Participants will receive a one-way reminder unit that will remotely transit information on medication adherence
Arm Name:MedMinder System - deactivated
Intervention Type:Device
Name:MedMinder System
Description:Participants will receive a fully activated reminder unit as well as at least one call per month from a counselor.
Arm Name:MedMinder System

Study Arms

Study Arm Type:Other
Arm Name:MedMinder System - deactivated
Study Arm Type:Other
Arm Name:MedMinder System

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:MedMinder Systems Inc.
Agency Class:Other
Agency Type:Collaborator
Agency Name:Narrows Institute for Biomedical Research

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 02, 2023

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