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Web Based Renal Transplant Patient Medication Education

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.
ClinicalTrials.gov Identifier: NCT00327483
Recruitment Status : Unknown
Verified May 2006 by Agency for Healthcare Research and Quality (AHRQ).
Recruitment status was:  Recruiting
First Posted : May 18, 2006
Last Update Posted : May 18, 2006
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Transplant Recipients Behavioral: Internet based education software Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Web Based Renal Transplant Patient Medication Education
Study Start Date : July 2005
Estimated Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Medication errors

Secondary Outcome Measures :
  1. Serum creatinine
  2. Rejection episodes
  3. Rehospitalizations
  4. Graft loss

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:age > 18 or capable of managing own medications

Exclusion Criteria:Education level below 10th grade

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00327483

United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, CT
Contact: Amy L Friedman, MD    203-785-2565    amy.friedman@yale.edu   
Principal Investigator: Amy L Friedman, MD         
Sponsors and Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Amy L Friedman, MD Yale University
More Information

ClinicalTrials.gov Identifier: NCT00327483     History of Changes
Other Study ID Numbers: R01HS015038-03 ( U.S. AHRQ Grant/Contract )
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: May 18, 2006
Last Verified: May 2006

Keywords provided by Agency for Healthcare Research and Quality (AHRQ):
Medication error
Patient Safety
Information technology