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

End Stage Renal Disease Clinical Trial

— DOPRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05441020
• Other study ID #: HD-HOME-01-TR
• Status: Completed
• Start date: November 18, 2022
• Est. completion date: March 20, 2023

Study information

• Verified date: July 2023
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: March 20, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Renal Failure

Intervention

Other:
• Administration of patient questionnaire
Patients undergoing maintenance hemodialysis complete electronic questionnaires on a tablet computer during this study to assess patient reported outcomes.

Locations

Country	Name	City	State
Turkey	Fresenius Nefroloji Hizmetleri A.S.-Bornova Branch	Izmir
Turkey	Fresenius Nefroloji Hizmetleri A.S.-Buca Branch	Izmir
Turkey	Fresenius Nefroloji Hizmetleri A.S.-Izmir Hatay Branch	Izmir
Turkey	Fresenius Nefroloji Hizmetleri A.S.-Izmir Üçkuyular Branch	Izmir
Turkey	Fresenius Nefroloji Hizmetleri A.S.-Karsiyaka Branch	Izmir
Turkey	Gaziemir Özel Saglik Hizmetleri Tesisleri Malzemeleri Sanayi ve Tic. A.S. - Gaziemir Branch	Izmir
Turkey	Izmir Renal Özel Saglik Tesisleri ve Malzemeleri Sanayi Tic. A.S- Yesilyurt Branch	Izmir

Sponsors (3)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH	acromion GmbH, Vector Psychometric Group, LLC

Country where clinical trial is conducted

Turkey, 

Outcome

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