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NCT Number: NCT05441020

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fresenius Nefroloji Hizmetleri A.Ş.-Bornova Branch, Izmir, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of patient questionnaire

Other

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

Primary outcomes

  1. Validation of Patient Reported Outcome Measures Information System-29 (PROMIS-29)

    Time frame: 2 weeks between test and retest

  2. Translating and testing PROMIS Cognitive Function and Abilities Subscale (PROMIS-CFS)

    Time frame: 2 weeks between test and retest

  3. 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

  4. 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

  5. Assessing feasibility and usefulness of measuring General Self-Efficacy Scale (GSE)

    Time frame: Single Administration in cross-sectional design

  6. Testing feasibility of the Telephone Cognitive Screen (T-Cog-S)

    Time frame: Single Administration in cross-sectional design

  7. 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

  8. Testing feasibility of Health Services Utilization and Productivity Loss Survey

    Time frame: Single Administration in cross-sectional design

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Collaborators

  • Vector Psychometric Group, LLC
  • acromion GmbH

Registry information

Acronym: DOPRO

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 1, 2022
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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