Renal failure Urological and Genital Diseases Renal failure
Conditions
Interventions
Participants will be randomly allocated 1:1 to the "prepare for responsive management" or "prepare for dialysis" treatment arms, stratified by site to ensure a balance in terms of local differences.
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Age
65 Years to 120 Years
Inclusion criteria
Inclusion criteria: Patients known to renal services with new or existing stage 5 CKD (eGFR <15, with at least one result confirming this in the last 12 months) and: 1. Aged 65+ with a World Health Organisation (WHO) performance status 3+ (0 = Fully active, able to carry out all normal activity without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours; 3 = Symptomatic and in a chair or in bed for greater than 50% of the day but not bedridden; 4 = Completely disabled; cannot carry out any self-care; totally confined to bed or chair), or 2. Aged 65+ with a Davies co-morbidity score 2+ (each of the following scores one point: Malignancy, ischaemic heart disease, peripheral vascular disease (including stroke), left ventricular dysfunction, diabetes mellitus, systemic collagen vascular disease, other significant pathology (including COPD, cirrhosis, psychiatric illness, HIV), or 3. Aged 80+
Exclusion criteria
Exclusion criteria: 1. Unable to consent, e.g. significant cognitive impairment or psychiatric disorder 2. Not medically fit for dialysis 3. Within 4 weeks of starting dialysis Added 01/07/2019: 4. Patients that have had a previous kidney transplant 5. Patients that are 'active' on the kidney transplant waiting list or being worked up for the kidney transplant waiting list
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean total of quality-adjusted life years (QALY) between the first patient recruited and the end of data collection is collected using the EQ-5D-5L at recruitment and every 4 months thereafter until 31 August 2025 (end of data collection). Updated 01/08/2024 to change the end of data collection from 1 October 2021 to 31 August 2025. | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival-related outcomes will be collected by research nurses from primary and secondary care clinical notes and during 4 monthly study visits/contacts. In addition, all participants will be asked on consenting to the RCT to consent to linkage to existing healthcare databases, such as Hospital Episode Statistics, the Office for National Statistics and the UK Renal Registry. This will provide data on the commencement of acute or chronic dialysis, hospital admissions for medical and surgical reasons and date and cause of death. 1. All-cause mortality 2. Cause-specific mortality 3. Place of death 4. Hospital-free days alive Patient-reported outcome related: 1. Generic quality of life is measured using the EQ-5D-5L at recruitment (baseline) and every 4 months thereafter until 31 August 2025 or until withdrawal from the study or death 2. Disease-specific quality of life/symptom burden is measured using the POS-S renal at recruitment (baseline) thereafter until 31 August 2025 or until withdrawal from the study or death 3. Capability gain specific to older persons is measured using the ICECAP-O at recruitment (baseline) and every 4 months thereafter until 31 August 2025 or until withdrawal from the study or death 4. Capability during end-of-life care is measured using the ICECAP-SCM at recruitment (baseline) and every 4 months thereafter until 31 August 2025 or until withdrawal from the study or death 5. Patient treatment burden is measured using the MTBQ at recruitment (baseline) and every 4 months thereafter until 31 August 2025 or until withdrawal from the study or death Physical functioning: 1. Is measured using the 'timed get up and go'- summary score at baseline and 12 monthly time points and assessed for changes over time. The physical assessment will be performed by the research nurse annually using standard operating procedures. 2. Grip strength is measured using a Jamar hand dynamometer at baseline and 12 monthly time points and assessed for changes over time. | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed