Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents in Hemodialysis Centers in Croatia
Croatian Time and Motion Survey for Anaemia Management With Erythropoietin Stimulating Agents in Haemodialysis Units
1 other identifier
observational
110
1 country
4
Brief Summary
This study is to document the time spent by health care personnel on anemia-related tasks, including preparation, distribution and administration of monopegylated epoetin beta (Mircera) or other erythropoiesis-stimulating agents (ESAs) in patients with end stage renal disease in hemodialysis centers in Croatia. The total average time will be determined for the same number of patients on monopegylated epoetin beta and patients on other ESAs. In addition, qualitative information will be obtained on changes in practice patterns that may have occurred with the introduction of monopegylated epoetin beta.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2011
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 7, 2015
CompletedFirst Posted
Study publicly available on registry
December 9, 2015
CompletedResults Posted
Study results publicly available
March 3, 2016
CompletedMarch 3, 2016
February 1, 2016
11 months
December 7, 2015
February 4, 2016
February 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs)
Health care personnel time (hours/year) includes preparation, distribution and administration of Erythropoiesis Stimulating Agents (ESAs)
Up to 3 months
Study Arms (2)
Monopegylated Epoetin Beta
Health care personnel performing anemia management tasks for patients using monopegylated epoetin beta.
Other Erythropoiesis Stimulating Agents (ESAs)
Health care personnel performing anemia management tasks for patients using other ESAs.
Interventions
No intervention administered in this study.
Eligibility Criteria
Health care personnel providing care for patients with renal anemia on monopegylated epoetin beta or other erythropoiesis stimulating agents (ESAs)
You may qualify if:
- \- Treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adult patients
You may not qualify if:
- Hypersensitivity to the active substance or to any of the excipients
- Uncontrolled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
Bjelovar, 43000, Croatia
Unknown Facility
Split, 21000, Croatia
Unknown Facility
Zadar, 23000, Croatia
Unknown Facility
Zagreb, 10000, Croatia
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2015
First Posted
December 9, 2015
Study Start
September 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
March 3, 2016
Results First Posted
March 3, 2016
Record last verified: 2016-02