Back to results

Evaluation of a Website on Living Kidney Donation for Hispanics

Primary Purpose

End Stage Kidney Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Website Intervention

About this trial

This is an interventional health services research trial for End Stage Kidney Disease focused on measuring Living kidney donation, End-stage renal disease, Latinos, Undocumented Immigrants, Bilingual, Spanish, Website, Dialysis, Hispanics, Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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?" .

Sites / Locations

University of California, Davis
Northwestern Memorial Hospital (NMH)

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Arm

Website Intervention

Arm Description

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.

Navigate website plus standard of care

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Website use and satisfaction

Will assess satisfaction and use of website 3 weeks after enrollment.

Full Information

NCT ID

NCT01859871

First Posted

May 20, 2013

Last Updated

November 18, 2015

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT01859871

Brief Title

Evaluation of a Website on Living Kidney Donation for Hispanics

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Kidney Disease

Keywords

Living kidney donation, End-stage renal disease, Latinos, Undocumented Immigrants, Bilingual, Spanish, Website, Dialysis, Hispanics, Transplantation

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

123 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Arm

Arm Type

No Intervention

Arm Description

Arm Title

Website Intervention

Arm Type

Experimental

Arm Description

Navigate website plus standard of care

Intervention Type

Behavioral

Intervention Name(s)

Website Intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Knowledge about Living Kidney Donation

Description

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Website use and satisfaction

Description

Will assess satisfaction and use of website 3 weeks after enrollment.

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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?" .

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elisa Gordon, PhD, MPH

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Davis

City

Davis

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Northwestern Memorial Hospital (NMH)

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26444846

Citation

Gordon EJ, Feinglass J, Carney P, Vera K, Olivero M, Black A, O'Connor K, MacLean J, Nichols S, Sageshima J, Preczewski L, Caicedo JC. A Culturally Targeted Website for Hispanics/Latinos About Living Kidney Donation and Transplantation: A Randomized Controlled Trial of Increased Knowledge. Transplantation. 2016 May;100(5):1149-60. doi: 10.1097/TP.0000000000000932.

Results Reference

derived

Learn more about this trial

Evaluation of a Website on Living Kidney Donation for Hispanics

We'll reach out to this number within 24 hrs