Chronic kidney disease (CKD) stages 2-4 Urological and Genital Diseases
Conditions
Interventions
Current interventions as of 18/12/2025:
An observational mixed methods cohort study will be conducted in order to develop a multivariate prognostic prediction model for CKD-specific symptom burden.
Sponsors
University Medical Center Hamburg-Eppendorf
Medical School Hamburg
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 27/09/2023: Inclusion criteria for the patient group: 1. Clinical diagnosis of CKD stages 2-4 2. Newly diagnosed with CKD 3. Age =18 years 4. Sufficient oral and written German language proficiency 5. Provision of written consent Inclusion criteria for the healthy control group: 1. To be at least 18 years old (equivalent to the patient group) 2. Sufficient knowledge of the German language 1. Clinical diagnosis of CKD stages 2-4 2. Newly diagnosed with CKD 3. Age =18 years 4. Sufficient oral and written German language proficiency 5. Provision of written consent
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 27/09/2023: Exclusion criteria for the patient group: 1. Acute severe somatic or psychiatric disease 2. Florid psychosis 3. Substance abuse disorder 4. Acute suicidality 5. Cognitive impairment 6. Planned dialysis within the next 6 months 7. Current dialysis 8. Dialysis in history longer than 3 months 9. Kidney transplantation 10. Life expectancy shorter than 6 months Exclusion criteria for the healthy control group: 1. Existence of a chronic kidney disease 2. Cognitive impairment (equivalent to the patient group) 3. Diagnosis of psychosis, schizophrenia etc. (equivalent to the patient group) 4. Drug addiction (also equivalent to the patient group) 5. Acute suicidality Previous participant exclusion criteria: 1. Acute severe somatic or psychiatric disease 2. Florid psychosis 3. Substance abuse disorder 4. Acute suicidality 5. Cognitive impairment 6. Planned dialysis within the next 6 months 7. Current dialysis 8. Dialysis in history longer than 3 months 9. Kidney transplantation 10. Life expectancy shorter than 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CKD-specific somatic symptom burden will be assessed with the CKD Symptom Burden Index (CKD-SBI) at baseline, after 6 and after 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CKD-related quality of life will be measured using the Kidney Disease Quality of Life 36-Item Short-Form Survey (KDQOL-36) which includes the general health-related quality of life scale SF-12 at baseline, 6 months, and 12 months. 2. General somatic symptom burden in CKD will be measured using the Patient Health Questionnaire-15 (PHQ-15) at baseline, 6 months, and 12 months. 3. Symptom intensity and interference measured using a Numeric Rating Scale (NRS) at baseline, 6 months, and 12 months. 4. Symptom-related disability measured using the Pain Disability Index (PDI) at baseline, 6 months, and 12 months. 5. General quality of life measured using the above-mentioned SF-12 at baseline, 6 months, and 12 months. 6. Disease-related variables, i.e. CKD cause, duration and severity as well as current and prior renal and comorbid illnesses measured using the Cumulative Illness Rating Scale (CIRS), core serum and urine laboratory parameters (glomerular filtration rate), venous, blood gas analysis, blood cell count, serum albumin, and cystatin c. Medication, allergies, pulse, blood pressure, respiratory rate, saturation, abdominal circumference, genetic predisposition, first diagnosis of CKD and first symptoms are measured asking the patients directly or taking missing information out of the patients’ physician’s letter. 7. Epigenetic variables, namely DNA methylation and histone modification. 8. Urokinase-type plasminogen activator receptor (suPAR) levels in the plasma measured with the suPARnostic ELISA kit (IBL international). 9. Concurrent treatments, assessed from the patients’ physicians. 10. Subjective side effects measured using a Numeric Rating Scale (NRS) at baseline, 6 months, and 12 months. 11. Adherence of treatment measured using the Medication Adherence Rating Scale (MARS-D) at baseline, 6 months, and 12 months. 12. Somatosensory amplification measured using the Somatosensory Amplification Scale (SSAS) at baseline, 6 months, and 12 months. 13. Illness per | — |
Countries
Germany
Outcome results
None listed