Prepare for kidney care

The prepare multi-morbid older people for end-stage kidney disease trial

Registry ID
ISRCTN17133653
Source registry
ISRCTN
Status
No longer recruiting
Study type
INTERVENTIONAL
Sponsor
North Bristol NHS Trust
Enrollment
512
Start date
2017-07-01
Completion date
2026-08-28
Last update
2026-08-17

Conditions

Summary

Renal failure

Detailed description

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. Minimisation will be used to ensure balance in age (65-80 vs 80+) and rate of kidney function decline (less or equal to vs more than 5 ml/min/1.73m2 in the last 12 months). Minimisation with probability weighting of 0.8 will be used in order to reduce predictability. Prepare for responsive management (intervention): A nurse who specialises in looking after people having responsive management (conservative care plus) will arrange a date for a first home visit. The first home visit will take place within 3 weeks of the nurse telephoning patient. Over the next 8 weeks the specialists nurse will visit the patient up to three times to assess patient needs and plan future treatment. All assessments and decisions will be agreed with the local site specialist renal team. Following this, the frequency of specialist nurse visits will depend on how often the patient and the patient’s specialist kidney team think the patient should be seen. Visits will be convenient for the patient and will alternate between hospital clinical visits and the nurse visiting the patient at home. In addition, the specialist nurse will contact the patient once a month to assess symptoms and review the treatment plan. If kidney function continues to fall and the patient develops symptoms which cannot be controlled by medication, the patient’s specialist kidney team will discuss the option of moving on to the next stage of support, which may involve other professionals, such as palliative care specialists, who can help control symptoms. Prepare for renal dialysis (comparator): Patients will attend the next scheduled kidney clinic appointment at the hospital, and will continue to attend kidney clinic appointments as often as the patient and specialist kidney team deem necessary. The specialist kidney t

Interventions

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

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

Locations

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