Evaluation of a Website on Living Kidney Donation for Hispanics

November 18, 2015 updated by: Elisa Gordon, Northwestern University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

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

  • United States
    • California
      • Davis, California, United States, 95817
        • University of California, Davis
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital (NMH)

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
Study participants will take the self-administered pre-test and receive the standard of care. After taking the pre-test, control arm participants will be done with study participation for that day and will attend the transplant center's education sessions. All participants will receive a letter and follow-up call at about two weeks later to schedule the final survey. They will take a final survey via telephone about 3 weeks later. The final survey includes the same topics as the pre-test. They will receive a thank you letter and gift card by mail after completing the final survey.
Experimental: Website Intervention
Navigate website plus standard of care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge about Living Kidney Donation
Time Frame: 3 weeks
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Website use and satisfaction
Time Frame: 3 weeks
Will assess satisfaction and use of website 3 weeks after enrollment.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Elisa Gordon, PhD, MPH, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

May 20, 2013

First Posted (Estimate)

May 22, 2013

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 18, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R39OT22059

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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