Telepharmacy Robotic Medicine Delivery Unit "TRMDU" Assessment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01007006
Recruitment Status : Unknown
Verified November 2009 by University of Illinois at Chicago.
Recruitment status was:  Not yet recruiting
First Posted : November 3, 2009
Last Update Posted : November 4, 2009
U.S. Army Medical Research and Materiel Command
Information provided by:
University of Illinois at Chicago

Brief Summary:
The objective of this study is to evaluate whether use of TRMDU in addition to medication review leads to improved outcomes and reduced health care costs for patients when compared with medication review alone. The study will be conducted in patients assigned to Department of Defense (DOD) Warrior Transition Units (WTU's), similar DOD units, and VA polytrauma centers.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Posttraumatic Stress Disorders Trauma Combat Disorders Pain Device: TMRDU Not Applicable

Detailed Description:

The military has been witnessing an increased number of patients with combat related impairments such as traumatic brain injury, post traumatic stress disorder and polytrauma which has lead to sub optimal medication self management. TRMDU is a medical device developed by INRange Systems Inc. that delivers medications and emits a sound alert to assist the patient. It can be used in a hospital, clinic, or residential setting. It can be remotely accessed by the health care professionals, and it allows physicians and other prescribers to remotely change scheduling or adjust prescriptions.

Use of TRMDU in hospital settings is expected to improve outcomes by improving medication self management, increasing adherence, reducing medication errors, and thereby associated costs. Further, it may contribute to overall improvement in a patient's psychological well-being and quality of life.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of a Telepharmacy Robotic Medicine Delivery Unit in Warrior Transition Unit Patients With Traumatic Brain Injury, Post-Traumatic Stress Disorder, or Polytrauma
Study Start Date : March 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: TMRDU
Telepharmacy Robotic Medicine Delivery Unit (TMRDU) group will receive TMRDU plus medication management
Device: TMRDU
The TMRDU will assist study subjects with taking their medications as prescribed by notifying them when the next dose is due and tracking whether and when it was taken.
Other Name: Electronic Medication Management Assistant, (EMMA) (R)
No Intervention: Control
Control arm will receive only medication management, no TMRDU.

Primary Outcome Measures :
  1. Adherence as measured by pill counts and self report (Morisky 8-item) [ Time Frame: Baseline, one, two and three months ]

Secondary Outcome Measures :
  1. Pain, psychological well-being, health related quality of life, cost [ Time Frame: Baseline, one, two, three months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: Subjects must be

  • At least 18 years of age
  • Alert and oriented to person , place and time
  • Primarily use English language for written and oral communication
  • Have diagnosis of Traumatic Brain Injury(TBI) Multiple Traumatic Brain Injury (MTBI), Post Traumatic Stress Disorder (PTSD) or Polytrauma.
  • Taking at least 4 chronic prescription medications
  • Living in a participating WTU or enrolled in Tampa Veterans Administration polytrauma outpatient treatment facility at the time of enrollment
  • Achieve a minimum score of 24 on Mini-Mental State Examination

Exclusion Criteria: If patients meet following criteria they are excluded from the study

  • Disabilities preventing safe use of the TRMDU
  • Projected life expectancy of less than 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01007006

Contact: Daniel R Touchette, Pharm.D., MA 3123553204
Contact: Jill M Winters, PhD 4149614202

United States, California
Naval Hospital Camp Pendleton Not yet recruiting
Camp Pendleton, California, United States, 92055
Contact: Caine Kras, Pharm D    760-725-3278   
United States, Florida
James A Haley VA Hospital and Polytrauma Facility Not yet recruiting
Tampa, Florida, United States, 33613
Contact: Stephen G Scott, DO    813-972-7506   
United States, Kentucky
Ireland Army Community Hospital Not yet recruiting
Fort Knox, Kentucky, United States, 40121
Contact: Kevin W Roberts         
Sponsors and Collaborators
University of Illinois at Chicago
U.S. Army Medical Research and Materiel Command
Principal Investigator: Daniel R Touchette, MA University of Illinois at Chicago
Principal Investigator: Jill M Winters, PhD Columbia College of Nursing

Additional Information:
Institute for Healthcare Improvement. (2009). Prevent adverse drug events (medication reconciliation).
Institute for Healthcare Improvement. (2009).
McNair, D., M. Lorr, et al. (1992). POMS Manual
National Council on Patient Information and Education. (2008).
Ware, J. E., K. K. Snow, et al. (1993). SF36 health survey: Manual and interpretation guide. Boston. MA, New England Medical Center

Responsible Party: Daniel R.Touchette, University of Illinois at Chicago Identifier: NCT01007006     History of Changes
Other Study ID Numbers: 07247003
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: November 4, 2009
Last Verified: November 2009

Keywords provided by University of Illinois at Chicago:
Telepharmacy Robotic Medicine Delivery Unit
Brain Injuries
Stress Disorders
Combat disorders

Additional relevant MeSH terms:
Brain Injuries
Stress Disorders, Traumatic
Brain Injuries, Traumatic
Stress Disorders, Post-Traumatic
Combat Disorders
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Mental Disorders