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Survey of Patient and Physician Awareness and Values to the Diagnosis and Treatment of Reduced Kidney Function (Chronic Kidney Disease) in Patients With High Blood Sugar Level (Type 2 Diabetes) (AWARE-CKD in T2D) (AWARE-CKD)

20. april 2022 opdateret af: Bayer

Awareness of Diagnosis and Treatment of Chronic Kidney Disease in Patients With Type 2 Diabetes

In this survey study, researchers want to find out more about how physicians are treating patients diagnosed with reduced kidney function (chronic kidney disease, CKD) and high blood sugar level (type 2 diabetes); what physicians know about the different treatment options available; and how they use this knowledge to treat their patients successfully. Additionally, researchers want to gather information about patient's awareness of their disease and which criteria they consider important for their treatment of the disease.

The study will survey a total of 150 patients with type 2 diabetes: 50 patients with mild CKD; 50 patients with moderate CKD; and 50 patients with severe CKD. Patients eligible for this study can be male or female and should be at least 18 years old. In addition, a total of 150 physicians will be surveyed. Physicians eligible for this study may be general practitioners, endocrinologist, or nephrologists.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The primary objective in this study is to assess the awareness, values and preferences of patients and physicians with respect to the risks, consequences and management of chronic kidney disease (CKD) in patients with type 2 diabetes.

Secondary objectives aim to assess awareness of available CKD treatments, referral tools and communication between patients and physicians.

Both patients and physicians will complete a survey that consists of various questions regarding the knowledge of disease, values and treatments, patient-physician interaction, physician referral tools and disease risk management.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
      • Multiple Locations, Canada
        • Many facilities

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with CKD and T2DM and treating general practitioners, endocrinologists, nephrologists in Canada

Beskrivelse

Inclusion Criteria:

  • For patient cohort:

    • Diagnosis of type 2 diabetes
    • eGFR < 60 ml/min per 1.73 m2 (measured within the last year) OR eGFR ≥ 60 ml/min per 1.73 m2 and uACR ≥ 2 (measured within the last year)
    • No documented non-diabetic etiology for renal disease

  • For physician cohort:

    • Licensed general practitioner, endocrinologist or nephrologist
    • Currently providing care for patients with chronic kidney disease and type 2 diabetes

Exclusion Criteria:

  • Patients with chronic kidney disease and type 2 diabetes who are physicians
  • Physicians with chronic kidney disease and type 2 diabetes

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
CKD-Patients
Cohort consisting of adult patients with a known diagnosis of type 2 diabetes and evidence of chronic kidney disease (CKD)
Andet: Ingen indgriben
Ingen intervention, observationsundersøgelse
Physicians treating CKD
Cohort consisting of licensed general practitioners, endocrinologists and nephrologists who are currently treating patients with both chronic kidney disease (CKD) and type 2 diabetes
Andet: Ingen indgriben
Ingen intervention, observationsundersøgelse

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Awareness of chronic kidney disease in T2D
Tidsramme: 1 day
Awareness will be summarized descriptively based on various survey questions.
1 day
Values regarding chronic kidney disease in T2D
Tidsramme: 1 day
Values regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.
1 day
Preferences regarding chronic kidney disease in T2D
Tidsramme: 1 day
Preferences regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.
1 day

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Awareness of available treatments for chronic kidney disease in T2D
Tidsramme: 1 day
Awareness of available treatments will be summarized descriptively based on various survey questions.
1 day
Physician awareness of available referral tools for the management of chronic kidney disease in T2D
Tidsramme: 1 day
Physician cohort only. Referral tools may comprise of various standard guidelines (e.g. KidneyWise, KDIGO guidelines, Diabetes Canada guidelines). A higher number of referral tools known by physicians indicates a better awareness of CKD referral tools.
1 day
Time point of communicated CKD diagnosis
Tidsramme: 1 day
1 day

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bayer

Samarbejdspartnere

LMC Diabetes & Endocrinology

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 (Faktiske)

16. september 2020

Primær færdiggørelse (Faktiske)

30. april 2021

Studieafslutning (Faktiske)

30. april 2021

Datoer for studieregistrering

Først indsendt

31. juli 2020

Først indsendt, der opfyldte QC-kriterier

31. juli 2020

Først opslået (Faktiske)

4. august 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 21225

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 Nyreinsufficiens, kronisk

Kliniske forsøg med Ingen indgriben

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Japan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner