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Telepharmacy Robotic Medicine Delivery Unit "TRMDU" Assessment

Primary Purpose

Traumatic Brain Injury, Posttraumatic Stress Disorders, Trauma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TMRDU
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Traumatic Brain Injury focused on measuring Telepharmacy Robotic Medicine Delivery Unit, Brain Injuries, Stress Disorders, Combat disorders, Polytrauma, Adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Naval Hospital Camp Pendleton
  • James A Haley VA Hospital and Polytrauma Facility
  • Ireland Army Community Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TMRDU

Control

Arm Description

Telepharmacy Robotic Medicine Delivery Unit (TMRDU) group will receive TMRDU plus medication management

Control arm will receive only medication management, no TMRDU.

Outcomes

Primary Outcome Measures

Adherence
Pill counts and self report (Morisky 8-item)

Secondary Outcome Measures

Intensity and type of pain
Short-Form McGill Pain Questionnaire; 15 descriptors rated on intensity of 0=none to 3=severe
Psychological well-being
Profile of Moods Brief Scale; scores of 6 subscales range from 0-20, with higher scores indicating higher distress, except for one subscale which is negatively scored.
Health related quality of life
Short-Form 36; 8 domains of general health with higher scores indicating less disability
Total cost of care
Six-month medication and medical cost of care will be extracted from the DOD prescription and medical claims databases

Full Information

First Posted
November 2, 2009
Last Updated
July 24, 2019
Sponsor
University of Illinois at Chicago
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT01007006
Brief Title
Telepharmacy Robotic Medicine Delivery Unit "TRMDU" Assessment
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 Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to gain approval from commanding Army and Navy officers to conduct study.
Study Start Date
December 2010 (Anticipated)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Posttraumatic Stress Disorders, Trauma, Combat Disorders, Pain
Keywords
Telepharmacy Robotic Medicine Delivery Unit, Brain Injuries, Stress Disorders, Combat disorders, Polytrauma, Adherence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMRDU
Arm Type
Experimental
Arm Description
Telepharmacy Robotic Medicine Delivery Unit (TMRDU) group will receive TMRDU plus medication management
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control arm will receive only medication management, no TMRDU.
Intervention Type
Device
Intervention Name(s)
TMRDU
Other Intervention Name(s)
Electronic Medication Management Assistant, (EMMA) (R)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence
Description
Pill counts and self report (Morisky 8-item)
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Intensity and type of pain
Description
Short-Form McGill Pain Questionnaire; 15 descriptors rated on intensity of 0=none to 3=severe
Time Frame
Three months
Title
Psychological well-being
Description
Profile of Moods Brief Scale; scores of 6 subscales range from 0-20, with higher scores indicating higher distress, except for one subscale which is negatively scored.
Time Frame
Three months
Title
Health related quality of life
Description
Short-Form 36; 8 domains of general health with higher scores indicating less disability
Time Frame
Three months
Title
Total cost of care
Description
Six-month medication and medical cost of care will be extracted from the DOD prescription and medical claims databases
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel R Touchette, MA
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jill M Winters, PhD
Organizational Affiliation
Columbia College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Hospital Camp Pendleton
City
Camp Pendleton
State/Province
California
ZIP/Postal Code
92055
Country
United States
Facility Name
James A Haley VA Hospital and Polytrauma Facility
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Ireland Army Community Hospital
City
Fort Knox
State/Province
Kentucky
ZIP/Postal Code
40121
Country
United States

12. IPD Sharing Statement

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URL
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Description
Institute for healthcare improvement "Preventing adverse drug events" Retrieved June 22, 2009
URL
http://www.talkaboutrx.org/documents/enhancing_prescription_medicine_adherence.pdf
Description
National Council on Patient Information and Education. (2008). "Public policy & adherence." Retrieved July 20, 2008

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Telepharmacy Robotic Medicine Delivery Unit "TRMDU" Assessment

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