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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Validation of Patient Reported Outcome Measures Information System-29 (PROMIS-29)
Timeframe: 2 weeks between test and retest
2
Translating and testing PROMIS Cognitive Function and Abilities Subscale (PROMIS-CFS)
Timeframe: 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
Timeframe: 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)
Timeframe: Single Administration in cross-sectional design
5
Assessing feasibility and usefulness of measuring General Self-Efficacy Scale (GSE)
Timeframe: Single Administration in cross-sectional design
6
Testing feasibility of the Telephone Cognitive Screen (T-Cog-S)
Timeframe: 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)