Table 1.
Assessments and follow-up
| Procedures | Data | Screening | Baseline | Treatment phase | Event based | |
|---|---|---|---|---|---|---|
| Face-to-face visit 1 | Follow-up (min = 32 month, max = 91 months) No visits |
|||||
| Linkage | Patient questionnaire (6 monthly) | |||||
| Eligibility assessment | √ | |||||
| Informed consent | √ | |||||
| Randomisation | √ | |||||
| Demographics | Age, sex, ethnicity, marital status, education level, smoking history | √ | ||||
| Clinical (1) | Primary renal disease, date first seen by a nephrologist, co-morbidities, dietary restrictions, 24-h urine volume | √ | ||||
| Clinical (2) | RRT treatment history, prescribed medication (including erythropoiesis-stimulating agents and phosphate binders) | √ | √ | |||
| Physical assessment (1) | Height, heart rate | √ | ||||
| Physical assessment (2) | Weight, systolic and diastolic blood pressure | √ | √ | |||
| Resource use (1) | Day case and inpatient hospital admissions (including surgical procedures performed) | √ | √ | |||
| Resource use (2) | Nursing home/residential home days/hospice days, other hospital out-patient services and primary care and community services in the last 6 months | √ | √ | |||
| Laboratory tests | Creatinine, urea, Kt/V, urea reduction ratio, albumin, haemoglobin, haematocrit, mean corpuscular volume, sodium, potassium, bicarbonate, corrected calcium, phosphate, C-reactive protein, intact parathyroid hormone, total cholesterol. (From the date of the study visit or the closest date prior to the study visit) | √ | √ | |||
| Patient reported | EQ-5D-5L and DSI and time to recovery [31] | √ | √ | |||
| SAE reporting | √ | |||||