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An Enhanced Medication Monitoring Program

Primary Purpose

Medication Adherence, Hypertension

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MedMinder System
MedMinder System - deactivated
Sponsored by
MedMinder Systems Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Medication Adherence

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA New York Harbor Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

MedMinder System

MedMinder System - deactivated

Arm Description

Outcomes

Primary Outcome Measures

medication adherence
change in systolic blood pressure

Secondary Outcome Measures

change in self-efficacy about taking medication
self-reported medication taking

Full Information

First Posted
April 14, 2010
Last Updated
November 7, 2011
Sponsor
MedMinder Systems Inc.
Collaborators
Narrows Institute for Biomedical Research
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1. Study Identification

Unique Protocol Identification Number
NCT01105104
Brief Title
An Enhanced Medication Monitoring Program
Official Title
An Enhanced Medication Monitoring Program
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedMinder Systems Inc.
Collaborators
Narrows Institute for Biomedical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MedMinder System
Arm Type
Other
Arm Title
MedMinder System - deactivated
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
MedMinder System
Intervention Description
Participants will receive a fully activated reminder unit as well as at least one call per month from a counselor.
Intervention Type
Device
Intervention Name(s)
MedMinder System - deactivated
Intervention Description
Participants will receive a one-way reminder unit that will remotely transit information on medication adherence
Primary Outcome Measure Information:
Title
medication adherence
Time Frame
6 months
Title
change in systolic blood pressure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
change in self-efficacy about taking medication
Time Frame
6 months
Title
self-reported medication taking
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sundar Natarajan, MD, M.Sc
Phone
212-951-3395
Email
sundar.natarajan@va.gov
Facility Information:
Facility Name
VA New York Harbor Healthcare System
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sundar Natarajan, MD, M.Sc.
Phone
212-951-3395
Email
sundar.natarajan@va.gov

12. IPD Sharing Statement

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An Enhanced Medication Monitoring Program

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