Evaluation of a Website on Living Kidney Donation for Hispanics

End Stage Kidney Disease Clinical Trial

Official title:

Evaluation of a Culturally Competent Website on Living Kidney Donation for Hispanics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859871
• Other study ID #: R39OT22059
• Status: Completed
• Phase: N/A
• First received: May 20, 2013
• Last updated: November 18, 2015
• Start date: May 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to increase understanding about living kidney donation (LKD) among Hispanic/Latino patients and public by increasing knowledge and positive attitudes about LKD. Improving Hispanics' understanding about LKD will ensure that Hispanic patients and public are fully informed of the treatment options for End Stage Kidney Disease.

Description:

The shortage of kidneys for transplantation, and ethnic disparities in living kidney donation rates are major public health problems. Hispanics need more kidney transplants, yet receive fewer living donor kidney transplants than they need. Factors known to contribute to Hispanics' low rates of living donation kidney transplantation include cultural beliefs, lack of knowledge, and negative attitudes about living kidney donation. Web-based interventions are promising as Hispanics are using the Internet at increasingly greater rates. However, few websites about transplantation are tailored to potential Hispanic kidney transplant candidates or the Hispanic community. This study aims to develop, test, and evaluate the effectiveness of a bilingual web-based educational resource targeted to Hispanic patients and the public, which can serve as a low-cost, convenient, and culturally competent tool to enhance knowledge about living kidney donation. Improving Hispanics' understanding about living kidney donation will promote their autonomy and self-determination by helping to ensure that Hispanic patients and public are fully informed of the treatment options for end-stage kidney disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: September 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (age = 18 years)

• Hispanics/Latinos

• ESRD patients who are scheduled to attend each participating transplant center's education sessions. Sessions mark the first phase of evaluation in order for patients to get wait listed for a transplant or for others to become a living kidney donor.

• Family and friends who accompany patients to the transplant center.

• Identification as Hispanic/Latino.

• Ability to come to Northwestern 3 hours prior to the scheduled education session.

• Ability to read. Reading ability will be assessed using the 5-point Likert scale question validated in English and Spanish:13 "How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?" People will be included if they reply 1-Never or 2-Rarely.

Exclusion Criteria:

• Non-identification as Hispanic/Latino.

• Inability to come to Northwestern 3 hours prior to the scheduled education session.

• Individuals who are not able to read Spanish or English. People will be excluded if they reply 3-Sometimes, 4-Often, and 5-Always to the question, "How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?" .

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Behavioral:
• Website Intervention
Study participants will take the self-administered pre-test in the intervention arm and will be introduced to the website to inform the public of various topics concerning end-stage kidney disease and kidney transplantation. Few websites about transplantation are tailored to potential Hispanic kidney transplant candidates or the Hispanic community. This website is designed to fill the void and be an effective bilingual web-based educational resource targeted to Hispanic patients and public which can serve as a culturally competent tool to enhance knowledge and attitudes about living kidney donation.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital (NMH)	Chicago	Illinois
United States	University of California, Davis	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge about Living Kidney Donation	Will assess change in knowledge and positive attitudes about risks, benefits, processes, and cultural factors associated with living kidney donation over time, and their associations with participant characteristics (i.e., age, literacy).	3 weeks	No
Secondary	Website use and satisfaction	Will assess satisfaction and use of website 3 weeks after enrollment.	3 weeks	No