- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00932334
Culturally Sensitive Behavioral Interventions to Enhance Living Kidney Donation / Living Kidney Transplantation (TALK)
7. december 2017 opdateret af: Johns Hopkins University
Title: Culturally tailored behavioral interventions to enhance living kidney donation/living kidney transplantation Applicants: Johns Hopkins Medical Institutions, National Kidney Foundation of Maryland Principal Investigator: Neil R. Powe, MD, MPH, MBA Address: 2024 E. Monument Street, Suite 2-600, Baltimore, MD, 21205 Phone: 410-955-6953; Email: npowe@jhmi.edu;
Fax: 410-955-0476 Rates of kidney donation have been largely stagnant for the past 10 years, resulting in large imbalances in numbers of persons on transplant waiting lists and the number of persons receiving kidney transplants.
Slow improvement in donation and transplantation rates are exacerbated by ethnic/racial disparities in kidney transplants, in which minorities, particularly African Americans, are far less likely to receive deceased kidney transplants.
Although living related kidney donation (LD) offers patients an opportunity to bypass many barriers contributing to disparities in kidney transplantation (e.g.
waiting lists and immunological incompatibility issues), African Americans remain less likely to receive living related kidney transplants (LRT), further exacerbating disparities in transplant rates.
Recent research demonstrates many ethnic minorities desire kidney transplantation, but rates of patient-physician and patient-family discussions regarding LD/LRT are suboptimal.
Compared to Whites, African Americans have also been shown to have disproportionately greater rates of culture-specific concerns (such as mistrust in health care) that could impede them from seeking important medical therapies.
It is unknown whether culturally tailored behavioral interventions to enhance patient/family decision-making regarding LD/LRT before the onset of end stage renal disease could improve rates of LD/LRT or could narrow racial disparities in the receipt of transplantation.
The primary goal of this proposal is a) to use focus group methodology to develop culturally tailored educational materials for patients/families considering LD/LRT and b) to perform a randomized controlled trial to test the effectiveness of a culturally tailored social-worker led intervention (using established behavioral problem-solving therapeutic techniques) in enhancing rates of family communication, donor evaluations, and transplantation.
The substantial experience of our consortium, including the National Kidney Foundation of Maryland and the Johns Hopkins Medical Institutions (Welch Center and the Medical Surgical Transplant Services in the School of Medicine), in the evaluation/ implementation of donor/recipient educational programs as well as the conduct of behavioral, epidemiologic and interventional studies related to donor/recipient health and psychology provides a strong foundation for the conduct of this study.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
145
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Age 18 to 70 with stage IV or stage V (non-dialysis dependent) chronic kidney disease
Exclusion Criteria:
- No evidence of cancer within 2 years prior to recruitment date
- No evidence of stage IV congestive heart failure
- No evidence of end-stage liver disease
- No evidence of unstable coronary artery disease
- No evidence of pulmonary hypertension
- No evidence of severe peripheral vascular disease
- No history of HIV
- No chronic (debilitating) infections
- No prior kidney transplant
- No prior completion of transplant evaluation process
- No prior dialysis treatment
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: TALK Plus
Participants receive and educational video and booklet about living kidney donation and meet with a social worker
|
Participants receive and educational video and booklet about living kidney donation and meet with a social worker
|
Eksperimentel: TALK Standard
Participants receive and educational video and booklet about living kidney donation
|
Participants receive and educational video and booklet about living kidney donation
|
Andet: Usual Care
Participants receive their usual medical care
|
Participants receive their usual care
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
enhancing rates of family communication, donor evaluations, and transplantation
Tidsramme: 6 months
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Leigh E Boulware, MD,MPH, Johns Hopkins University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Boulware LE, Hill-Briggs F, Kraus ES, Melancon JK, Falcone B, Ephraim PL, Jaar BG, Gimenez L, Choi M, Senga M, Kolotos M, Lewis-Boyer L, Cook C, Light L, DePasquale N, Noletto T, Powe NR. Effectiveness of educational and social worker interventions to activate patients' discussion and pursuit of preemptive living donor kidney transplantation: a randomized controlled trial. Am J Kidney Dis. 2013 Mar;61(3):476-86. doi: 10.1053/j.ajkd.2012.08.039. Epub 2012 Oct 22.
- Boulware LE, Hill-Briggs F, Kraus ES, Melancon JK, McGuire R, Bonhage B, Senga M, Ephraim P, Evans KE, Falcone B, Troll MU, Depasquale N, Powe NR. Protocol of a randomized controlled trial of culturally sensitive interventions to improve African Americans' and non-African Americans' early, shared, and informed consideration of live kidney transplantation: the Talking About Live Kidney Donation (TALK) Study. BMC Nephrol. 2011 Jul 8;12:34. doi: 10.1186/1471-2369-12-34.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2009
Primær færdiggørelse (Faktiske)
1. maj 2011
Studieafslutning (Faktiske)
1. maj 2011
Datoer for studieregistrering
Først indsendt
2. juli 2009
Først indsendt, der opfyldte QC-kriterier
2. juli 2009
Først opslået (Skøn)
3. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. december 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. december 2017
Sidst verificeret
1. december 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NA_00006752
- R39OT07537
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Kronisk nyresygdom
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Jules Bordet InstituteMacopharma; Belgian Hematological SocietyRekrutteringRefractory Chronic Graft Versus Host Disease (cGVHD)Belgien
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Novartis PharmaceuticalsLedigPrimær myelofibrose (PMF) | Polycytæmi Vera (PV) | Post polycytæmi myelofibrose (PPV MF) | Trombocytæmi myelofibrose (PET-MF) | Alvorlig/meget svær COVID-19 sygdom | Steroid Refractory Acute Graft Versus Host Disease (SR aGVHD) | Steroid Refractory Chronic Graft Versus Host Disease (SR cGVHD)
Kliniske forsøg med TALK PLUS
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University of KansasUniversity of North CarolinaRekruttering
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Consumer Wellness SolutionsAfsluttet
-
California State University, Dominguez HillsRekrutteringHIV-negativ og endnu ikke på PrEPForenede Stater
-
Oregon Research Behavioral Intervention Strategies...National Institute on Minority Health and Health Disparities (NIMHD)Afsluttet
-
University of VictoriaSwitch Research; Mathematics of Information Technology and Complex SystemsAfsluttetMentalt helbred | SelvplejeCanada
-
Duke UniversityAfsluttet
-
The Hong Kong Polytechnic UniversityIkke rekrutterer endnu
-
Virginia Commonwealth UniversityGeorgetown UniversityRekrutteringBrystkræftForenede Stater
-
Oregon Research Behavioral Intervention Strategies...Eunice Kennedy Shriver National Institute of Child Health and Human Development...AfsluttetStress | Forældre-barn relationer | Børns adfærd | Selveffektivitet | Følelsesmæssig tilpasning | Forældrepraksis | SøvnproblemerForenede Stater
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University of ManitobaCanadian Institutes of Health Research (CIHR)AfsluttetPalliativ pleje | Familie | End of Life CareCanada