End Stage Kidney DiseaseNCT01859871
Evaluation of a Website on Living Kidney Donation for Hispanics
A study testing Website Intervention in people with End Stage Kidney Disease, run by Northwestern University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End Stage Kidney Disease
- What is being tested?
- Website Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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?" .
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Memorial Hospital (NMH)
Chicago, Illinois, 60611
University of California, Davis
Davis, California, 95817
About this study
Official title: 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.
Read the 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.
- Conditions
- End Stage Kidney Disease
- Being tested
- Website Intervention
- Keywords
- Living kidney donation, End-stage renal disease, Latinos, Undocumented Immigrants, Bilingual, Spanish, Website, Dialysis, Hispanics, Transplantation
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Website InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Website Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 weeks
Secondary outcomes (1)
Website use and satisfaction
Will assess satisfaction and use of website 3 weeks after enrollment.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Gordon, Northwestern University
- Investigators
- Elisa Gordon, PhD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859871
- Sponsor's protocol ID
- R39OT22059
- Status last verified
- Nov 2015
- First submitted
- 20 May 2013
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26444846
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Culturally Competent Website on Living Kidney Donation for Hispanics
- ClinicalTrials.gov ID
- NCT01859871
- Acronym / sponsor ID
- R39OT22059
- Conditions
- End Stage Kidney Disease
- Keywords
- Living kidney donation, End-stage renal disease, Latinos, Undocumented Immigrants, Bilingual, Spanish, Website, Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Website InterventionNavigate website plus standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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?" .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Website InterventionStudy 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. | Behavioural | Website Intervention |
Primary outcome
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).
1 secondary outcome
Website use and satisfaction
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Derived from this study: PubMed 26444846Gordon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Gordon, PhD, MPH principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Website Intervention in people with End Stage Kidney Disease, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge about Living Kidney Donation (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.