Status:
COMPLETED
Development, Feasibility Testing and Validation of a Survey Set to Measure Patient-Reported Outcomes Among Hemodialysis Patients in Turkey
Lead Sponsor:
Fresenius Medical Care Deutschland GmbH
Collaborating Sponsors:
acromion GmbH
Vector Psychometric Group, LLC
Conditions:
Renal Failure
End Stage Renal Disease
Eligibility:
All Genders
18-80 years
Brief Summary
Development, feasibility testing and validation of a Survey Set to Measure Patient-Reported Outcomes among Hemodialysis Patients in Turkey: Creating and testing an electronic patient questionnaire tha...
Detailed Description
Individuals with chronic kidney disease represent a growing population in adult and pediatric practices. This has resulted in a drive to optimize patient care and outcomes. Historically, healthcare ou...
Eligibility Criteria
Inclusion
- Informed consent signed and dated by study patient and investigator/authorized physician
- Age of 18 -80 years
- Ability to understand the nature and requirements of the study
- Literacy in Turkish including the ability to read with regards to visual acuity and the ability to understand what is read
- General ability to use a tablet (the study nurse will instruct the patient how to use the study-tablet during the conduct of the study)
- To be on stable maintenance hemodialysis (HD) for over 3 months (prevalent patients)
Exclusion
- Any conditions which could interfere with the patient's ability to comply with the study
- Previous participation in the same study
- Participation in an interventional clinical study during the preceding 30 days
- Serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease, which causes life-expectancy less than a year,
- Acute cardiovascular events including myocardial infarction, stroke and unstable angina pectoris requiring hospitalization within the last 6 months,
- To have cognitive or mental co-morbidities which prevent reliable answering of questions
Key Trial Info
Start Date :
November 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 20 2023
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT05441020
Start Date
November 18 2022
End Date
March 20 2023
Last Update
August 1 2023
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Fresenius Nefroloji Hizmetleri A.Ş.-Bornova Branch
Izmir, Turkey (Türkiye), 35040
2
Fresenius Nefroloji Hizmetleri A.Ş.-Buca Branch
Izmir, Turkey (Türkiye), 35340
3
Fresenius Nefroloji Hizmetleri A.Ş.-İzmir Üçkuyular Branch
Izmir, Turkey (Türkiye), 35340
4
Fresenius Nefroloji Hizmetleri A.Ş.-İzmir Hatay Branch
Izmir, Turkey (Türkiye), 35360