Telepharmacy Robotic Medicine Delivery Unit "TRMDU" Assessment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University of Illinois at Chicago.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01007006
First received: November 2, 2009
Last updated: November 3, 2009
Last verified: November 2009
  Purpose

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 Intervention
Traumatic Brain Injury
Posttraumatic Stress Disorders
Trauma
Combat Disorders
Pain
Device: TMRDU

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

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

Secondary Outcome Measures:
  • Pain, psychological well-being, health related quality of life, cost [ Time Frame: Baseline, one, two, three months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 165
Study Start Date: March 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01007006

Contacts
Contact: Daniel R Touchette, Pharm.D., MA 3123553204 drtouche@uic.edu
Contact: Jill M Winters, PhD 4149614202 jwinters@ccon.edu

Locations
United States, California
Naval Hospital Camp Pendleton Not yet recruiting
Camp Pendleton, California, United States, 92055
Contact: Caine Kras, Pharm D    760-725-3278    caine.kras@med.navy.mil   
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    steven.scott@va.gov   
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
Investigators
Principal Investigator: Daniel R Touchette, MA University of Illinois at Chicago
Principal Investigator: Jill M Winters, PhD Columbia College of Nursing
  More Information

Additional Information:
Publications:

Responsible Party: Daniel R.Touchette, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01007006     History of Changes
Other Study ID Numbers: 07247003, W81XWH-09-1-0092
Study First Received: November 2, 2009
Last Updated: November 3, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Combat Disorders
Multiple Trauma
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Brain Injuries
Wounds and Injuries
Anxiety Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 31, 2014