MD.2 Medication Dispenser Medication Adherence Study

October 7, 2009 updated by: Interactive Medical Developments

Medication Dispenser: MD2: Improving Health Outcomes

The objective of this study is to quantify the benefits of using the MD.2 on health outcomes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A sizeable portion of admissions to hospital and even nursing homes can be avoided if individuals with medication management problems were provided assistive devices to assist with their medications. The MD.2 medication dispenser and monitoring system was developed by Interactive Medical Developments LC and may offer increased support to the elderly with fewer human resources and a substantially reduced cost to the public health system. A rigorous evaluation of this technology has not been conducted. The objective of this Phase III clinical trial (Phase II of this STTR Fast Track Application) is to quantify the benefits of using the MD.2 on health outcomes. The specific aims are to: (1) Quantify healthcare utilization including hospitalizations and emergency room visits for MD.2 clients compared to control clients, (2) Determine the length of time in case management for MD.2 clients compared to control clients, (3) Measure changes in caregiver burden between those with the MD.2 and those with usual medication routines and (4) Determine if cognitive and functional characteristics influence compliance rates among the MD.2 clients and control clients. This study will be conducted in all counties in four of the Area Agencies on Aging in Iowa (who participated in the Phase I study), with the Veteran's Administration(VA)in Iowa, and with Area Agencies on Aging in Illinois. One hundred and fifty clients will be randomized to receive the MD.2 and 150 clients will be randomized to the control group. Primary caregivers for these 300 subjects will also be recruited. Nurses employed by Interactive Medical Developments LC will collect all data. From homecare charts/claims, age, sex, residence, living status, social support, activities of daily living, instrumental activities of daily living, cognition, medical conditions and medication lists will be obtained. Enrolled subjects will also complete an interviewer-administered survey of the Geriatric Depression Scale, SF-12 Health Status Inventory, self-reported medication compliance and recent hospitalizations and emergency room visits. Caregivers will complete the Caregiver Burden Interview. Poisson regression and Cox proportional hazards models will be the primary statistical approaches.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242-1101
        • Recruiting
        • University of Iowa
        • Contact:
        • Principal Investigator:
          • Karen Farris, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

A client must:

  • Be coming up for regular review in Case or Medication Management
  • Require medication management services
  • Have two or more doses of medication per day
  • Have someone to fill MD.2
  • Be in independent living (may be assisted living with NO medication management services)
  • Be expected to live through follow-up period of six months
  • Have an active phone line that can be utilized by the MD.2 system.

Exclusion Criteria:

A client cannot have/or be the following:

  • Have someone available to administer medications for every dose
  • Have someone in household who is likely to interfere with MD.2
  • Blind AND deaf
  • Eligible for hospice
  • An MD.2 currently

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Those subjects that receive an MD.2 Medication Dispenser
Behavioral: MD.2 Medication Dispenser
For those subjects receiving an MD.2 Medication Dispenser, the machine organizes medications and provides verbal and auditory explicit reminders for individuals to take their medications. At the scheduled time, the patient gets a series of reminders. The patient is then expected to push a single button to dispense a pre-filled medication cup. An automatic record is kept of the subject's medication adherence. Interviewer-administered surveys of the Geriatric Depression Scale, SF-12 Health Status Inventory, self-reported medication compliance and recent hospitalizations and emergency room visits will be given. Caregivers will complete the Caregiver Burden Interview.
No Intervention: B
Control subjects that do not receive an MD.2 Medication Dispenser, but continue to take their medications utilizing standard care, such as pill boxes, etc.
Behavioral: MD.2 Medication Dispenser
For those subjects receiving an MD.2 Medication Dispenser, the machine organizes medications and provides verbal and auditory explicit reminders for individuals to take their medications. At the scheduled time, the patient gets a series of reminders. The patient is then expected to push a single button to dispense a pre-filled medication cup. An automatic record is kept of the subject's medication adherence. Interviewer-administered surveys of the Geriatric Depression Scale, SF-12 Health Status Inventory, self-reported medication compliance and recent hospitalizations and emergency room visits will be given. Caregivers will complete the Caregiver Burden Interview.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of hospitalizations and emergency room visits will be compared between the MD.2 and control clients
Time Frame: per month (30 client days) over 6 consecutive months
per month (30 client days) over 6 consecutive months

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare the length of time in case management for MD.2 clients to control clients.
Time Frame: Over 6 consecutive months.
Over 6 consecutive months.
Measure changes in caregiver stressors and burden between those with the MD.2 and those with their usual medication routine.
Time Frame: Over 6 consecutive months
Over 6 consecutive months
Determine if cognitive and functional characteristics influence compliance rates among the frail elderly using the MD.2.
Time Frame: Over 6 consecutive months
Over 6 consecutive months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Interactive Medical Developments

Collaborators

University of Iowa
National Institutes of Health (NIH)
Department of Health and Human Services

Investigators

  • Principal Investigator: Karen Farris, Ph.D., University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Anticipated)

May 1, 2008

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 19, 2007

Study Record Updates

Last Update Posted (Estimate)

October 8, 2009

Last Update Submitted That Met QC Criteria

October 7, 2009

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PHS 2003-2 FAST TRACK
  • 5R42AG021844-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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