An observational study in Renal Failure and End Stage Renal Disease, sponsored by Fresenius Medical Care Deutschland GmbH. Completed at 7 sites in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Fresenius Medical Care Deutschland GmbH · Observational
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 that is suitable to measure health-related quality of life in Turkish dialysis patients in clinical as well as in home care settings.
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 outcomes focused on morbidity, mortality or complication rates, but failed to provide meaningful data on the value of medicine to patients and the quality of life gained or lost. Several studies have revealed that treatments aimed at minimizing morbidity and mortality in end-stage renal disease (ESRD) have very often been ineffective. Therefore, attention to HRQOL among ESRD patients is crucial.
The aim of this pilot study is creating and testing an electronic patient questionnaire that is suitable to measure health-related quality of life in Turkish dialysis patients. This questionnaire consists of the PROMIS Cognitive Function and Abilities Subset, the PROMIS-29, a new post-dialysis recovery time module, the MOS-Social Support Scale (MOS-SSS), Subscales of the KDQOL SF 1.3 (sexual function \& cognitive function), the General Self-Efficacy Scale and the Health Services Utilization And Productivity Loss Survey which are to be delivered together on a tablet computer.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 173 is above the median of 120 across 431 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Fresenius Medical Care Deutschland GmbH is the lead sponsor of 36 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Turkish dialysis patients (in center or home dialysis)
Exclusion Criteria:
Patients undergoing maintenance hemodialysis complete electronic questionnaires on a tablet computer during this study to assess patient reported outcomes.
Validation of Patient Reported Outcome Measures Information System-29 (PROMIS-29)
Time frame: 2 weeks between test and retest
Translating and testing PROMIS Cognitive Function and Abilities Subscale (PROMIS-CFS)
Time frame: 2 weeks between test and retest
Translating and testing feasibility of a new post-dialysis recovery time module adapted from PROMIS scale on fatigue
Time frame: Single Administration in cross-sectional design
Testing feasibility and usefulness of measuring Social Support, potential reduction of items and internal consistency of the MOS-Social Support Scale (MOS-SSS)
Time frame: Single Administration in cross-sectional design
Assessing feasibility and usefulness of measuring General Self-Efficacy Scale (GSE)
Time frame: Single Administration in cross-sectional design
Testing feasibility of the Telephone Cognitive Screen (T-Cog-S)
Time frame: Single Administration in cross-sectional design
Testing feasibility of the kidney disease targeted subscales (sexual function & cognitive function) of the Kidney Disease Quality of Life Short Form Version 1.3 (KDQOL SF 1.3)
Time frame: Single Administration in cross-sectional design
Testing feasibility of Health Services Utilization and Productivity Loss Survey
Time frame: Single Administration in cross-sectional design
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Fresenius Medical Care Deutschland GmbH