- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00327483
Web Based Renal Transplant Patient Medication Education
May 16, 2006 updated by: Agency for Healthcare Research and Quality (AHRQ)
Information technology will be brought directly to renal transplant recipients to help them learn about the large number of medications they are required to take on a life long basis, in order to prevent errors and improve safety.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Transplant recipients are particularly vulnerable to medication errors because of the large number of chronic drugs needed to prevent rejection and treat comorbidities.
Compliance failures directly compromise patient safety through acute immunologic events and premature graft loss.
For society, the loss of invested fiscal and organic (organs) resources is catastrophic.
As the unique constant in the chain of people who provide, modify and consume prescription medications, health information technology should be focused on empowering the patient to prevent medication errors.
Our principal clinical hypothesis is that HIT can be proven to improve patient safety by minimizing medication errors.
Specific aims address the creation of new knowledge and evidence ( in a renal transplant population) of benefits of widely applicable HIT tools.
Web enabled education of two groups, new (<6 months) and established (> 6 months), kidney transplant recipients is proposed.
Study Type
Interventional
Enrollment
250
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, CT
- Recruiting
- Yale New Haven Hospital
-
Contact:
- Amy L Friedman, MD
- Phone Number: 203-785-2565
- Email: amy.friedman@yale.edu
-
Principal Investigator:
- Amy L Friedman, MD
-
-
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
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:age > 18 or capable of managing own medications
-
Exclusion Criteria:Education level below 10th grade
-
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: Educational/Counseling/Training
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Medication errors
|
Secondary Outcome Measures
Outcome Measure |
---|
Serum creatinine
|
Rejection episodes
|
Rehospitalizations
|
Graft loss
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Amy L Friedman, MD, Yale University
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
July 1, 2005
Study Completion
April 1, 2006
Study Registration Dates
First Submitted
May 16, 2006
First Submitted That Met QC Criteria
May 16, 2006
First Posted (Estimate)
May 18, 2006
Study Record Updates
Last Update Posted (Estimate)
May 18, 2006
Last Update Submitted That Met QC Criteria
May 16, 2006
Last Verified
May 1, 2006
More Information
Terms related to this study
Other Study ID Numbers
- R01HS015038-03 (U.S. AHRQ 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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-
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