An Enhanced Medication Monitoring Program

Hypertension Clinical Trial

Official title:

An Enhanced Medication Monitoring Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01105104
• Other study ID #: 1R43HL097395-01A1
• Status: Recruiting
• Phase: Phase 1
• First received: April 14, 2010
• Last updated: November 7, 2011
• Start date: September 2011
• Est. completion date: June 2013

Study information

• Verified date: November 2011
• Source: MedMinder Systems Inc.
• Contact: Sundar Natarajan, MD, M.Sc
• Phone: 212-951-3395
• Email: sundar.natarajan[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension
• Medication Adherence

Intervention

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
Participants will receive a one-way reminder unit that will remotely transit information on medication adherence

Locations

Country	Name	City	State
United States	VA New York Harbor Healthcare System	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
MedMinder Systems Inc.	Narrows Institute for Biomedical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	medication adherence		6 months	No
Primary	change in systolic blood pressure		6 months	No
Secondary	change in self-efficacy about taking medication		6 months	No
Secondary	self-reported medication taking		6 months	No