MD.2 Medication Dispenser Medication Adherence Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Interactive Medical Developments.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Iowa
Information provided by:
Interactive Medical Developments
ClinicalTrials.gov Identifier:
NCT00560001
First received: November 15, 2007
Last updated: October 7, 2009
Last verified: November 2007
  Purpose

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


Condition Intervention Phase
Frail Elderly
Medication Errors
Behavioral: MD.2 Medication Dispenser
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Medication Dispenser: MD2: Improving Health Outcomes

Resource links provided by NLM:


Further study details as provided by Interactive Medical Developments:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Compare the length of time in case management for MD.2 clients to control clients. [ Time Frame: 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 ]
  • Determine if cognitive and functional characteristics influence compliance rates among the frail elderly using the MD.2. [ Time Frame: Over 6 consecutive months ]

Estimated Enrollment: 600
Study Start Date: January 2006
Estimated Study Completion Date: May 2008
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00560001

Contacts
Contact: Karen Farris, Ph.D. 319-384-4516 karen-farris@uiowa.edu
Contact: Julie Lang, M.S.; M.B.A 319-384-2815 julie-lang@uiowa.edu

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242-1101
Contact: Julie Lang, M.S.; M.B.A.    319-384-2815    julie-lang@uiowa.edu   
Principal Investigator: Karen Farris, Ph.D.         
Sponsors and Collaborators
Interactive Medical Developments
University of Iowa
Investigators
Principal Investigator: Karen Farris, Ph.D. University of Iowa
  More Information

Additional Information:
Publications:

ClinicalTrials.gov Identifier: NCT00560001     History of Changes
Other Study ID Numbers: PHS 2003-2 FAST TRACK, 5 R42 AG021844-02
Study First Received: November 15, 2007
Last Updated: October 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Interactive Medical Developments:
frail elderly
medication errors
patient compliance & attitudes
guideline adherence

ClinicalTrials.gov processed this record on August 19, 2014