Recruiting
Phase 1

Observational Study

Sponsor:

MedMinder Systems Inc.

Code:

NCT01105104

Conditions

Medication Adherence

Hypertension

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

MedMinder System

MedMinder System - deactivated

Study Details

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.

Conditions

Medication Adherence

Hypertension

Study ID

NCT01105104

Start date

Sep, 2011

Status verified date

Nov, 2011

Completion date

Jun, 2013

Anticipated

Primary completion date

May, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: MedMinder System

other: MedMinder System - deactivated

Interventions

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

Primary outcome measure

  • medication adherence [ Time Frame: 6 months ]
  • change in systolic blood pressure [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Sundar Natarajan, MD, M.Sc

212-951-3395sundar.natarajan@va.gov

Locations

VA New York Harbor Healthcare System

Recruiting

New York, New York, United States, 10010

Contacts

Sundar Natarajan, MD, M.Sc.

212-951-3395sundar.natarajan@va.gov

More Information

Sponsor

MedMinder Systems Inc.

Last update posted

Nov 8, 2011

Last verified

Nov, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MedMinder Systems Inc. on 2011-11-08.