Web Based Renal Transplant Patient Medication Education

Renal Transplant Recipients Clinical Trial

Official title:

Web Based Renal Transplant Patient Medication Education

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00327483
• Other study ID #: RO1-HS15038-03
• Status: Recruiting
• Phase: Phase 4
• First received: May 16, 2006
• Last updated: May 16, 2006
• Start date: July 2005
• Est. completion date: April 2006

Study information

• Verified date: May 2006
• Source: Agency for Healthcare Research and Quality (AHRQ)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Exclusion Criteria:Education level below 10th grade

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Renal Transplant Recipients

Intervention

Behavioral:
• Internet based education software

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication errors
Secondary	Serum creatinine
Secondary	Rejection episodes
Secondary	Rehospitalizations
Secondary	Graft loss