Evaluation of a Website on Living Kidney Donation for Hispanics

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Elisa Gordon, Northwestern University
ClinicalTrials.gov Identifier:
NCT01859871
First received: May 20, 2013
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
End Stage Kidney Disease
Behavioral: Website Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Evaluation of a Culturally Competent Website on Living Kidney Donation for Hispanics

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Knowledge about Living Kidney Donation [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Website use and satisfaction [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Will assess satisfaction and use of website 3 weeks after enrollment.


Estimated Enrollment: 220
Study Start Date: May 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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?" .
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859871

Contacts
Contact: Elisa Gordon, PhD, MPH 312-503-5563

Locations
United States, California
University of California, Davis Not yet recruiting
Davis, California, United States, 95817
Contact: Junichiro Sageshima, MD    916-734-7977    junichiro.sageshima@ucdmc.ucdavis.edu   
Contact: Shari Nichols         
United States, Illinois
Northwestern Memorial Hospital (NMH) Recruiting
Chicago, Illinois, United States, 60611
Contact: Elisa Gordon, PhD, MPH    312-503-5563    e-gordon@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Elisa Gordon, PhD, MPH Northwestern University
  More Information

No publications provided

Responsible Party: Elisa Gordon, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01859871     History of Changes
Other Study ID Numbers: R39OT22059
Study First Received: May 20, 2013
Last Updated: September 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Living kidney donation
End-stage renal disease
Latinos
Undocumented Immigrants
Bilingual
Spanish
Website
Dialysis
Hispanics
Transplantation

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014