Tokyo, April 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061293) titled 'Fukushima Dialysis Cohort Study: Association Between Patient-Reported Outcomes (PROs) and Prognosis in Patients Receiving Maintenance Hemodialysis' on April 17.

Study Type: Observational

Primary Sponsor: Institute - Fukushima Medical University

Condition: Condition - Patients receiving maintenance hemodialysis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to longitudinally evaluate patient-reported outcomes (PROs), particularly health-related quality of life (HR-QOL), in patients receiving maintenance dialysis at multiple centers in Fukushima Prefecture, and to clarify their associations with prognosis. In addition, this study aims to identify factors associated with HR-QOL in order to provide evidence that may contribute to the development of indicators for QOL assessment, extension of healthy life expectancy, and optimization of dialysis-related healthcare resources in patients receiving maintenance dialysis. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Patients receiving hemodialysis three or more times per week for at least 3 months at participating institutions during the enrollment period from February 2021 to February 2027 2.Age 18 years or older at enrollment 3.Written informed consent obtained from the patient or legally acceptable representative Key exclusion criteria - 1.Patients with active malignancy 2.Patients with active infection 3.Pregnant patients 4.Patients with psychiatric disorders or psychiatric symptoms judged to make participation in the study difficult Target Size - 500

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2020 Year 12 Month 15 Day Date of IRB - 2021 Year 01 Month 19 Day Anticipated trial start date - 2021 Year 02 Month 01 Day Last follow-up date - 2029 Year 01 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070134

Disclaimer: Curated by HT Syndication.