End Stage Renal Disease (ESRD)PREPAREDNCT01439516
Providing Resources to Enhance African American Patients' Readiness to Make Decisions About Kidney Disease (PREPARED) Study
A study testing Information in people with End Stage Renal Disease (ESRD) and Chronic Kidney Disease (CKD), run by Johns Hopkins University at 1 site in United States.
Trial summary
African Americans are less likely than Whites to receive kidney transplants, despite their being more than two-fold as likely as Whites to develop end stage renal disease (ESRD). Living related kidney donation (LD) offers patients an opportunity to bypass many barriers to receipt of deceased kidney transplants (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD)
- What is being tested?
- Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Apr 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- End-stage renal disease (ESRD) receiving hemodialysis for less than 2 years
- Self-reported as African-American
- English Speaking
Who cannot join
- Dementia
- Prior Kidney Transplant
- Non-English Speaking
- Cancer within 2 years prior to recruitment date
- Stage 4 Congestive Heart Failure
- End Stage Liver Disease
Show all 10Show fewer
- Unstable Coronary Artery Disease
- Pulmonary Hypertension
- Severe Peripheral Vascular Disease
- Chronic Debilitating Infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Information and Financial Interventions for Kidney Donation in African Americans
African Americans are less likely than Whites to receive kidney transplants, despite their being more than two-fold as likely as Whites to develop end stage renal disease (ESRD). Living related kidney donation (LD) offers patients an opportunity to bypass many barriers to receipt of deceased kidney transplants (e.g. waiting lists and immunological incompatibility), but minorities are less likely to receive living related kidney transplants (LRT). Evidence suggests African Americans may not discuss LD/LRT with their families or physicians at optimal rates, and thus may not have adequate information to initiate or participate in shared decision-making regarding LD/LRT. African Americans may also have financial concerns regarding convalescence and out of pocket expenses related to LD/LRT, another barrier impeding LD/LRT.
The primary goals of this study are to overcome these important barriers by enhancing ethnic minorities' consideration of LD/LRT through the promotion of shared decision-making regarding LD/LRT and provision of financial assistance for out of pocket expenses. The investigators specific aims are: a) to develop culturally sensitive informational (audiovisual) and financial interventions and b) to perform a randomized controlled trial to assess their effectiveness in increasing pursuit of LD/LRT among African American patients with ESRD and their families. The investigators hypothesize: (1) Patients and families who view informational materials designed to promote shared decision-making regarding LD/LRT will be more likely than patients and families not viewing these materials to discuss LD/LRT with family and with health care professionals. Patients and families viewing such informational materials will also be more likely than those not viewing these materials to pursue and complete the LD/LRT process and (2) patients and their families who are offered the intervention to promote shared decision-making plus a financial assistance intervention for potential live kidney donors will be more likely than patients and families not offered both interventions to pursue and complete the LD/LRT process.
Read the detailed description
The investigators will enroll 210 adult African American patients with new-onset ESRD from dialysis facilities in the Baltimore metropolitan area and measure their initial commitment to pursue LD/LRT. Participants will then be randomized to one of three groups: 1) informational intervention alone (PREPARED education), 2) informational intervention plus living donor financial assistance program (PREPARED plus financial assistance), and 3) no intervention (Usual Care). The investigators will follow participants for up to 6 months for progression in their commitment to LD/LRT.
- Being tested
- Information
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InformationBehavioural
Receipt of PREPARED educational book and video about treatments for end stage renal disease (ESRD)
| Study group | Role | What they receive |
|---|---|---|
| Information | Experimental | Participants randomized to this arm of the study will received the PREPARED educational book and video. Receives: Behavioral: Information |
| Information and Financial Assistance | Experimental | Participants randomized to this arm of the study will receive the PREPARED educational book and video plus financial assistance for family members to cover costs associated with an evaluation for becoming a live kidney donor. Receives: Behavioral: Information |
| Usual Care | No intervention | Participants randomized to this arm of the study will receive usual care from their physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pursuit of Living Related Transplantation
Measurement of patients' pursuit of LRT will be performed using a series of questions that assess the participants' knowledge, interest, and perceived barriers to LRT. We will also ascertain use of the living donor financial assistance among potential donors and completion of evaluation and kidney transplant among both patient participants and potential living donors.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startAug 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Ebony Boulware, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439516
- Sponsor's protocol ID
- NA_00011846
- Other IDs
- 1R01DK079682-01
- Acronym
- PREPARED
- Status last verified
- Aug 2018
- First submitted
- 31 Aug 2011
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boulware LE, Ephraim PL, Ameling J, Lewis-Boyer L, Rabb H, Greer RC, Crews DC, Jaar BG, Auguste P, Purnell TS, Lamprea-Monteleagre JA, Olufade T, Gimenez L, Cook C, Campbell T, Woodall A, Ramamurthi H, Davenport CA, Choudhury KR, Weir MR, Hanes DS, Wang NY, Vilme H, Powe NR. Effectiveness of informational decision aids and a live donor financial assistance program on pursuit of live kidney transplants in African American hemodialysis patients. BMC Nephrol. 2018 May 3;19(1):107. doi: 10.1186/s12882-018-0901-x.
PubMed 29724177Ephraim PL, Powe NR, Rabb H, Ameling J, Auguste P, Lewis-Boyer L, Greer RC, Crews DC, Purnell TS, Jaar BG, DePasquale N, Boulware LE. The providing resources to enhance African American patients' readiness to make decisions about kidney disease (PREPARED) study: protocol of a randomized controlled trial. BMC Nephrol. 2012 Oct 12;13:135. doi: 10.1186/1471-2369-13-135.
PubMed 23057616
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Information and Financial Interventions for Kidney Donation in African Americans
- ClinicalTrials.gov ID
- NCT01439516
- Acronym / sponsor ID
- PREPARED / NA_00011846
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 23 Sep 2011 (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.
African Americans are less likely than Whites to receive kidney transplants, despite their being more than two-fold as likely as Whites to develop end stage renal disease (ESRD). Living related kidney donation (LD) offers patients an opportunity to bypass many barriers to receipt of deceased kidney transplants (e.g. waiting lists and immunological incompatibility), but minorities are less likely to receive living related kidney transplants (LRT). Evidence suggests African Americans may not discuss LD/LRT with their families or physicians at optimal rates, and thus may not have adequate information to initiate or participate in shared decision-making regarding LD/LRT. African Americans may also have financial concerns regarding convalescence and out of pocket expenses related to LD/LRT, another barrier impeding LD/LRT.
The primary goals of this study are to overcome these important barriers by enhancing ethnic minorities' consideration of LD/LRT through the promotion of shared decision-making regarding LD/LRT and provision of financial assistance for out of pocket expenses. The investigators specific aims are: a) to develop culturally sensitive informational (audiovisual) and financial interventions and b) to perform a randomized controlled trial to assess their effectiveness in increasing pursuit of LD/LRT among African American patients with ESRD and their families. The investigators hypothesize: (1) Patients and families who view informational materials designed to promote shared decision-making regarding LD/LRT will be more likely than patients and families not viewing these materials to discuss LD/LRT with family and with health care professionals. Patients and families viewing such informational materials will also be more likely than those not viewing these materials to pursue and complete the LD/LRT process and (2) patients and their families who are offered the intervention to promote shared decision-making plus a financial assistance intervention for potential live kidney donors will be more likely than patients and families not offered both interventions to pursue and complete the LD/LRT process.
Detailed description
The investigators will enroll 210 adult African American patients with new-onset ESRD from dialysis facilities in the Baltimore metropolitan area and measure their initial commitment to pursue LD/LRT. Participants will then be randomized to one of three groups: 1) informational intervention alone (PREPARED education), 2) informational intervention plus living donor financial assistance program (PREPARED plus financial assistance), and 3) no intervention (Usual Care). The investigators will follow participants for up to 6 months for progression in their commitment to LD/LRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Information | Experimental | Behavioral: InformationParticipants randomized to this arm of the study will received the PREPARED educational book and video. |
| Information and Financial Assistance | Experimental | Behavioral: InformationParticipants randomized to this arm of the study will receive the PREPARED educational book and video plus financial assistance for family members to cover costs associated with an evaluation for becoming a live kidney donor. |
| Usual Care | No intervention | –Participants randomized to this arm of the study will receive usual care from their physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- End-stage renal disease (ESRD) receiving hemodialysis for less than 2 years
- Self-reported as African-American
- English Speaking
Key exclusion criteria (10 listed)
- Dementia
- Prior Kidney Transplant
- Non-English Speaking
- Cancer within 2 years prior to recruitment date
- Stage 4 Congestive Heart Failure
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 |
|---|---|---|
| InformationReceipt of PREPARED educational book and video about treatments for end stage renal disease (ESRD) | Behavioural | Information, Information and Financial Assistance |
Primary outcome
Pursuit of Living Related Transplantation
Time frame: 6 months
Measurement of patients' pursuit of LRT will be performed using a series of questions that assess the participants' knowledge, interest, and perceived barriers to LRT. We will also ascertain use of the living donor financial assistance among potential donors and completion of evaluation and kidney transplant among both patient participants and potential living donors.
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 21 Aug 2018.
- Derived from this study: PubMed 29724177Boulware LE, Ephraim PL, Ameling J, Lewis-Boyer L, Rabb H, Greer RC, Crews DC, Jaar BG, Auguste P, Purnell TS, Lamprea-Monteleagre JA, Olufade T, Gimenez L, Cook C, Campbell T, Woodall A, Ramamurthi H, Davenport CA, Choudhury KR, Weir MR, Hanes DS, Wang NY, Vilme H, Powe NR. Effectiveness of informational decision aids and a live donor financial assistance program on pursuit of live kidney transplants in African American hemodialysis patients. BMC Nephrol. 2018 May 3;19(1):107. doi: 10.1186/s12882-018-0901-x.
- Derived from this study: PubMed 23057616Ephraim PL, Powe NR, Rabb H, Ameling J, Auguste P, Lewis-Boyer L, Greer RC, Crews DC, Purnell TS, Jaar BG, DePasquale N, Boulware LE. The providing resources to enhance African American patients' readiness to make decisions about kidney disease (PREPARED) study: protocol of a randomized controlled trial. BMC Nephrol. 2012 Oct 12;13:135. doi: 10.1186/1471-2369-13-135.
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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.
Leigh Ebony Boulware, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information in people with End Stage Renal Disease (ESRD) and Chronic Kidney Disease (CKD), run by Johns Hopkins University at 1 site 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 4 inclusion and 10 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 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Pursuit of Living Related Transplantation (time frame: 6 months). 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 NCT01439516, which also lists 2 linked publications.
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 21 Aug 2018.