NCT01859871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

May 20, 2013

Last Update Submit

November 18, 2015

Conditions

Keywords

Living kidney donationEnd-stage renal diseaseLatinosUndocumented ImmigrantsBilingualSpanishWebsiteDialysisHispanicsTransplantation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Website use and satisfaction

    3 weeks

Study Arms (2)

Control Arm

NO INTERVENTION

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.

Website Intervention

EXPERIMENTAL

Navigate website plus standard of care

Behavioral: Website Intervention

Interventions

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.

Website Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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?" .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, Davis

Davis, California, 95817, United States

Location

Northwestern Memorial Hospital (NMH)

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Elisa Gordon, PhD, MPH

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 22, 2013

Study Start

May 1, 2013

Primary Completion

February 1, 2015

Study Completion

September 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations