- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01298115
Patient INformation About Options for Treatment - PINOT (PINOT)
Patient Information About Options for Treatment of Stage 5 Chronic Kidney Disease
This prospective observational study is designed to find out what treatment options new patients with chronic kidney disease learn about from their renal unit.
Aims: To determine the proportion of new CKD patients who receive information about treatment options prior to commencing dialysis, pre-emptive transplantation or conservative management. To determine the timing (i.e. patient's stage of disease) when information is given. To find out whether patients have a friend or family member with them when information is given.
Research Design and methods: This study is an assessment of CKD education practices. Nephrologists and pre-dialysis coordinators from each renal unit will complete questionnaires about information that was given to each new dialysis, pre-emptive transplant or conservatively managed patient that started treatment during a 3 month period.
Study hypothesis: Approximately one third of CKD patients will receive information after starting treatment. There will be a positive association between in-centre haemodialysis and later referral, non-English speaking background, and advancing age. Significance: The results from this national audit will provide Australian nephrologists and renal nurses with evidence about CKD education practices and compliance with clinical practice guidelines. The results may highlight opportunities for improvement in practice.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Additional research objectives and key research questions:
1. To determine the proportion of patients who receive information about: pre-emptive transplantation; peritoneal dialysis; home haemodialysis; centre based haemodialysis; supported non-dialytic care or conservative management.
3. To determine the proportion of incident patients that have a non-English speaking background (NESB) requiring an interpreter or translated materials.
4. To examine associations between age, gender, health insurance status, NESB, CKD stage and information provided on initial treatment commenced.
5. To determine the proportion of patients who choose not to dialyse.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
New South Wales
-
Sydney, New South Wales, Australië, 2006
- University of Sydney
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Patients attending Australian adult or pediatric renal units
- Patients with Stage 5 chronic kidney disease commencing dialysis or having a pre-emptive transplant or with decision made for conservative care and eGFR < 15ml/min/1.73m2 between 1st July and 30th September 2009
Exclusion Criteria:
- Patients with acute kidney injury not requiring chronic renal replacement therapy
- Patients with a failing kidney transplant returning to dialysis
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Stage 5 chronic kidney disease
Incident patients commencing renal replacement therapy or conservative care
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Proportion of incident Stage 5 CKD patients who receive information about their treatment options prior to commencing treatment
Tijdsspanne: Time prior to commencement of treatment. eg. 3 months
|
Time prior to commencement of treatment. eg. 3 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Stage of CKD (based on eGFR) when information about treatment options is first given
Tijdsspanne: one time point prior to commencement of treatment
|
one time point prior to commencement of treatment
|
|
Patient and unit characteristics associated with commencing renal replacement therapy versus conservative care
Tijdsspanne: One time point based on commencement date of first treatment
|
One time point based on commencement date of first treatment
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Kirsten Howard, PhD, University of Sydney
Publicaties en nuttige links
Algemene publicaties
- Morton RL, Howard K, Webster AC, Snelling P. Patient information about options for treatment: Methods of a national audit of information provision in chronic kidney disease. Nephrology (Carlton). 2010 Sep;15(6):649-52. doi: 10.1111/j.1440-1797.2010.01340.x.
- Morton RL, Howard K, Webster AC, Snelling P. Patient INformation about Options for Treatment (PINOT): a prospective national study of information given to incident CKD Stage 5 patients. Nephrol Dial Transplant. 2011 Apr;26(4):1266-74. doi: 10.1093/ndt/gfq555. Epub 2010 Sep 6.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RM-1/09
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .