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

NCT05441020 | Completed

• 1 other identifier: HD-HOME-01-TR
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 7

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.

Conditions

Renal Failure; End Stage Renal Disease

Keywords

Hemodialysis; Psychometric tests; Patient questionnaire

Outcome Measures

Primary Outcomes (8)

• 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 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 Telephone Cognitive Screen (T-Cog-S)

  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

Interventions

Administration of patient questionnaire OTHER

Patients undergoing maintenance hemodialysis complete electronic questionnaires on a tablet computer during this study to assess patient reported outcomes.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Turkish dialysis patients (in center or home dialysis)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead
• acromion GmbH: collaborator
• Vector Psychometric Group, LLC: collaborator

Study Sites (7)

Fresenius Nefroloji Hizmetleri A.Ş.-Bornova Branch

Izmir, 35040, Turkey (Türkiye)

Location

Fresenius Nefroloji Hizmetleri A.Ş.-Buca Branch

Izmir, 35340, Turkey (Türkiye)

Location

Fresenius Nefroloji Hizmetleri A.Ş.-İzmir Üçkuyular Branch

Izmir, 35340, Turkey (Türkiye)

Location

Fresenius Nefroloji Hizmetleri A.Ş.-İzmir Hatay Branch

Izmir, 35360, Turkey (Türkiye)

Location

İzmir Renal Özel Sağlık Tesisleri ve Malzemeleri Sanayi Tic. A.Ş- Yeşilyurt Branch

Izmir, 35370, Turkey (Türkiye)

Location

Gaziemir Özel Sağlık Hizmetleri Tesisleri Malzemeleri Sanayi ve Tic. A.Ş. - Gaziemir Branch

Izmir, 35410, Turkey (Türkiye)

Location

Fresenius Nefroloji Hizmetleri A.Ş.-Karşıyaka Branch

Izmir, 35510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hayriye Elbi, Prof Dr

  Ege University Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: July 1, 2022
• Study Start: November 18, 2022
• Primary Completion: February 2, 2023
• Study Completion: March 20, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

TU (7)