An Enhanced Medication Monitoring Program

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by MedMinder Systems Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Narrows Institute for Biomedical Research
Information provided by (Responsible Party):
MedMinder Systems Inc.
ClinicalTrials.gov Identifier:
NCT01105104
First received: April 14, 2010
Last updated: November 7, 2011
Last verified: November 2011
  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.


Condition Intervention Phase
Medication Adherence
Hypertension
Device: MedMinder System
Device: MedMinder System - deactivated
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Enhanced Medication Monitoring Program

Resource links provided by NLM:


Further study details as provided by MedMinder Systems Inc.:

Primary Outcome Measures:
  • medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • change in systolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in self-efficacy about taking medication [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • self-reported medication taking [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
MedMinder System - deactivated Device: MedMinder System - deactivated
Participants will receive a one-way reminder unit that will remotely transit information on medication adherence

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105104

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

Locations
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    sundar.natarajan@va.gov   
Sponsors and Collaborators
MedMinder Systems Inc.
Narrows Institute for Biomedical Research
  More Information

No publications provided

Responsible Party: MedMinder Systems Inc.
ClinicalTrials.gov Identifier: NCT01105104     History of Changes
Other Study ID Numbers: 1 R43 HL097395-01A1
Study First Received: April 14, 2010
Last Updated: November 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014