Development, Feasibility Testing and Validation of a Survey Set to Measure Patient-Reported Outcomes Among Hemodialysis Patients in Turkey

Completed

• Conditions: Renal Failure; End Stage Renal Disease

• Registration Number: NCT05441020
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

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 that is suitable to measure health-related quality of life in Turkish dialysis patients in clinical as well as in home care settings.

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 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.

Study Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-07-01
• Study Start: 2022-11-18
• Primary Completion: 2023-02-02
• Study Completion: 2023-03-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-30
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of Patient Reported Outcome Measures Information System-29 (PROMIS-29)	2 weeks between test and retest
Translating and testing PROMIS Cognitive Function and Abilities Subscale (PROMIS-CFS)	2 weeks between test and retest
Translating and testing feasibility of a new post-dialysis recovery time module adapted from PROMIS scale on fatigue	Single Administration in cross-sectional design
Testing feasibility of the Telephone Cognitive Screen (T-Cog-S)	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)	Single Administration in cross-sectional design
Assessing feasibility and usefulness of measuring General Self-Efficacy Scale (GSE)	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)	Single Administration in cross-sectional design
Testing feasibility of Health Services Utilization and Productivity Loss Survey	Single Administration in cross-sectional design

Trial Locations

Locations (7)

Fresenius Nefroloji Hizmetleri A.Ş.-Bornova Branch; 🇹🇷 İzmir, Turkey

Fresenius Nefroloji Hizmetleri A.Ş.-İzmir Hatay Branch; 🇹🇷 İzmir, Turkey

Fresenius Nefroloji Hizmetleri A.Ş.-İzmir Üçkuyular Branch; 🇹🇷 İzmir, Turkey

Fresenius Nefroloji Hizmetleri A.Ş.-Karşıyaka Branch; 🇹🇷 İzmir, Turkey

Fresenius Nefroloji Hizmetleri A.Ş.-Buca Branch; 🇹🇷 İzmir, Turkey

İzmir Renal Özel Sağlık Tesisleri ve Malzemeleri Sanayi Tic. A.Ş- Yeşilyurt Branch; 🇹🇷 İzmir, Turkey

Gaziemir Özel Sağlık Hizmetleri Tesisleri Malzemeleri Sanayi ve Tic. A.Ş. - Gaziemir Branch; 🇹🇷 İzmir, Turkey