Advanced Chronic Kidney Disease Urological and Genital Diseases
Conditions
Interventions
Participants randomised to the intervention arm will commence monthly self-reporting of their health status using an online electronic Patient-Reported Outcome (ePROM system), after receiving a face-t
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =18 years old 2. Ability to provide fully informed consent for participation in the study 3. Patients under the care of the renal services at Queen Elizabeth Hospital Birmingham (QEHB) 4. Patients meeting the trial definition of advanced CKD: an eGFR =6 and =15 mL/min/1.73m2 (inclusive) OR a projected risk of progression to end-stage renal failure within 2-years =20% using the 4-variable Tangri renal risk calculator
Exclusion criteria
Exclusion criteria: 1. Patients unwilling to use the ePROM intervention 2. Patients who, in the opinion of the consenting professional, cannot speak, read or write English sufficiently well to complete the ePROM unaided 3. An episode of acute kidney injury (defined in accordance with national guidelines) within the last 3 months 4. Patients meeting the trial definition of End Stage Renal Disease (currently receiving dialysis/scheduled to start in the next 2 weeks OR received/scheduled date to receive a kidney transplant OR eGFR < = 5ml/min/1.73m2) 5. A terminal illness that, in the opinion of the consultant consultant assessing eligibility, is likely to lead to the death of the patient within 6 months of starting participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility is measured via review of recruitment and retention rates, data collection processes, data completeness and adherence to the ePROM intervention, at the end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life is measured using the validated EQ-5D-5L at baseline, 3, 6 9 and 12 months 2. Clinical condition is measured using: Serum Creatinine, Calcium, Phosphate, Bicarbonate, Albumin, eGFR, ACR, blood pressure, and for participants with diabetes: glucose and HbA1c, at baseline, 3, 6 9 and 12 months 3. Clinical event data, including: progression to end stage renal disease, contact with health care professionals in secondary care (outpatient clinics and A&E), inpatient hospitalisation and death, are measured using Clinical Report Forms at baseline, 3, 6 9 and 12 months 4. Health resource use data are measured using Clinical Report Forms at baseline, 3, 6 9 and 12 months | — |
Countries
England, United Kingdom
Contacts
Public ContactDerek Kyte
Outcome results
None listed