Prepare for kidney care
| ISRCTN | ISRCTN17133653 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17133653 |
| Secondary identifying numbers | CPMS 32254 |
- Submission date
- 15/05/2017
- Registration date
- 31/05/2017
- Last edited
- 29/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims:
The kidneys are responsible for filtering out the waste products and excess water in the blood, and converting them into urine. If the kidneys stop working properly, then the body is unable to get rid of the waste products building up in the blood. Eventually, the kidneys are no longer able to support the body’s needs (kidney failure) and so a treatment to replace the work of the failed kidneys is needed. When kidney function drops to 15% of normal, patients experience tiredness, loss of appetite and sickness. At this stage, dialysis or kidney transplantation is considered. Dialysis is a treatment which involves diverting the blood into an external machine so that it can be cleaned, before being returned to the body. This treatment can take place in hospital or at home. There is evidence that some older people with many medical problems (co-morbidities) do just as well with conservative care as dialysis, but more evidence is needed to help patients and their families make the best decision. The aim of this study is to provide clear evidence to help patients and their families reach the best decision for them and influence NHS policy nationally on the best care for people living with kidney disease.
Who can participate?
People with kidney failure aged 80+ years and those aged 65+ years with multiple health problems.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive conservative care with additional home visits. This involves home visits with a nurse to assess the patient's care needs and their priorities during responsive management. The nurse calls the patient at home regularly to monitor symptoms and check that sufficient help is available. There are regular check-ups with the nurse at home and in-hospital visits. Hospital visits are less frequent than in people preparing for renal dialysis. Those in the second group come to hospital clinic visits regularly as per standard practice. Surgery to prepare for dialysis takes place. Dialysis is started when the doctor, nurse and patient agree it is needed. There are regular visits to hospital for treatment or check-ups. Participants are followed up every four months until the end of data collection or death.
What are the possible benefits and risks of participating?
There are no guaranteed benefits of taking part, however, the treatment given as part of the study may lead to an improvement in symptoms and general health. There are no notable risks involved with participating.
Where is the study run from?
Southmead Hospital and 29 other NHS hospitals in England (UK)
When is the study starting and how long is it expected to run for?
January 2017 to August 2025
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Jo Worthington
Prepare4KC@bristol.ac.uk
Contact information
Scientific
Bristol Trials Centre
University of Bristol
1-5 Whiteladies Road
Bristol
BS2 1NU
United Kingdom
 ORCID ID |
0000-0002-2860-3511 |
|---|---|
| Phone | +44 (0)117 331 4586 |
| Prepare4KC@bristol.ac.uk |
Scientific
UK Renal Registry
Learning and Research
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
| ORCID ID |
0000-0002-5199-3925 |
|---|---|
| Phone | +44 (0)117 414 8150 |
| mdfjc@bristol.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Process of Care, Complex Intervention, Management of Care, Active Monitoring |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN17133653_PIS_05May17_V3.0.docx |
| Scientific title | The prepare multi-morbid older people for end-stage kidney disease trial |
| Study objectives | The aim of this study is to establish the effectiveness and cost-effectiveness of preparing for responsive management compared with preparing for renal dialysis in relation to quality and length of life in frail, older people with multiple health problems and advanced chronic kidney disease. |
| Ethics approval(s) | South Central - Berkshire Research Ethics Committee, 05/05/2017, ref: 17/SC/0070 |
| Health condition(s) or problem(s) studied | Renal failure |
| Intervention | 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 team will discuss dialysis treatment options that are available and decided which one is most suitable. Depending on the dialysis treatment chosen, the patient may need scans and an operation to prepare for dialysis. If kidney function continues to decline and the patient develops symptoms of kidney failure, then the specialist team will recommend starting dialysis immediately. If the patient and the specialist kidney team consider it appropriate, other professionals, such as palliative care specialists, may become involved to help control symptoms. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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. The physical assessment will be performed by the research nurse annually using standard operating procedures. Relative/carer reported outcomes: 1. Impact on carers is measured using the PACKS impact on carers questionnaire (added 07/06/2017: adapted from the iMTA valuation of informal care questionnaire) at participant recruitment (baseline) and every 4 months thereafter until 31 August 2025, or until participant withdraws from the study or dies 2. Impacts on carers is assessed using the QUALYCARE post-bereavement survey obtaining retrospective information covering the 1 week preceding death if the study participant dies. QUALYCARE data will be collected at 3-6 months after participant death Health economic: 1. Incremental cost-per QALY gained from the health perspective is assessed by QALYs generated using EQ-5D-5L at recruitment (baseline) and every 4 months thereafter until 31 August 2025 2. Cost per equivalent year of full/sufficient capability gained, from health and societal perspectives is assessed using ICECAP (ICECAP-O the ICEpop capability measure for older people and ICECAP-SCM the ICEpop capability measure for supportive care management) at recruitment (baseline) and every 4 months thereafter until 31 August 2025 Updated 01/08/2024 to change the end of data collection from 1 October 2021 to 31 August 2025. |
| Overall study start date | 01/01/2017 |
| Completion date | 31/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 512; UK Sample Size: 512 |
| Total final enrolment | 448 |
| Key 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+ |
| Key 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 |
| Date of first enrolment | 01/07/2017 |
| Date of final enrolment | 31/08/2024 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Corerys Mill Lane
Stevenage
SG1 4AB
United Kingdom
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
University Hospitals of North Midlands NHS Trust
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom
Gloucester
GL1 3NN
United Kingdom
London
SE5 9RS
United Kingdom
Carshalton
SM5 1AA
United Kingdom
Heath Park
Cardiff
CF14 4XW
United Kingdom
Canterbury
CT1 3NG
United Kingdom
TR1 3HD
United Kingdom
Manchester
M13 9WL
United Kingdom
Edinburgh
EH16 4SA
United Kingdom
Leicester
LE5 4PW
United Kingdom
Newcastle upon Tyne
NE7 7DN
United Kingdom
Portsmouth
PO6 3LY
United Kingdom
York
YO31 8HE
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Fulwood
Preston
PR2 9HT
United Kingdom
Liverpool
L7 8XP
United Kingdom
Bradford
BD5 0NA
United Kingdom
Dumfries
DG2 8RX
United Kingdom
London
SE1 9RT
United Kingdom
S5 7AU
United Kingdom
Londonderry
BT47 6SB
United Kingdom
Craigavon
BT63 5QQ
United Kingdom
Antrim
BT41 2RL
United Kingdom
Manchester
M5 5AP
United Kingdom
Dundee
DD1 9SY
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Sponsor information
Hospital/treatment centre
Southmead Hospital
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 (0)117 414 9330 |
|---|---|
| researchsponsor@nbt.nhs.uk | |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/11/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Current publication and dissemination plan as of 13/01/2020: 1. Trial protocol: To be published in Trials, with an intention to publish by 31/06/2021 2. Trial Statistical Analysis Plan: To be published in Trials by 31/05/2021 3. Final study results: planned publication in a high impact peer reviewed journal with an intention to publish by 31/12/2024 Previous publication and dissemination plan as of 01/07/2019: 1. Trial protocol to be published in Trials with an intention to publish by 31/12/2019 2. Statistics Analysis Plan to be published by 31/12/2019 3. Final study results: planned publication in a high impact peer reviewed journal with an intention to publish by 31/12/2022 Previous publication and dissemination plan: 1. Trial protocol: To be published in Trials, with an intention to publish by 31/12/2017 2. Trial Statistical Analysis Plan: To be published in Trials by 31/12/2019 3. Final study results: planned publication in a high impact peer reviewed journal with an intention to publish by 31/12/2022 |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. Name of repository - Bristol Randomised Trial Collaboration Data that will be shared - anonymised derived data When the data will become available and for how long - following publication of the main trial papers until data have to be destroyed (currently 15 years following the end of the trial) By what access criteria the data will be shared including with whom, for what types of analyses, and by what mechanism, whether consent from participants was obtained - The Trial Management Group will consider all requests for access to the data on a case-by-case basis Whether consent from participants was obtained - consent was/is obtained Comments on data anonymisation - data will be anonymised before release Any ethical or legal restrictions - data release will need to comply with all conditions of the data providers (e.g. NHS Digital and the UK Renal Registry) and the funder (NIHR HTA). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V3.0 | 05/05/2017 | 31/05/2017 | No | Yes |
| Participant information sheet | version v5.0 | 12/11/2018 | 01/07/2019 | No | Yes |
| Other publications | Background and recruitment progress | 27/05/2021 | 05/05/2023 | Yes | No |
| Protocol file | version 4.0 | 09/09/2017 | 05/05/2023 | No | No |
| HRA research summary | 26/07/2023 | No | No | ||
| Participant information sheet | version 8.0 | 20/11/2023 | 23/05/2024 | No | Yes |
| Protocol file | version 9.0 | 20/11/2023 | 23/05/2024 | No | No |
| Protocol file | version 10.0 | 26/06/2024 | 01/08/2024 | No | No |
| Protocol article | 17/10/2024 | 29/10/2024 | Yes | No |
Additional files
- ISRCTN17133653_PIS_05May17_V3.0.docx
- Uploaded 31/05/2017
- ISRCTN17133653_PIS_v5.0_12Nov2018.docx
- Uploaded 01/07/2019
- ISRCTN17133653_Protocol_v4.0_09Sep2017.pdf
- ISRCTN17133653 PrepareKC_PIS_RCT_v8.0_20Nov23.pdf
- ISRCTN17133653 PrepareKC protocol v9.0_20Nov23.pdf
- ISRCTN17133653_PROTOCOL_V10.0_26Jun24.pdf
Editorial Notes
29/10/2024: Publication reference added.
06/09/2024: Total final enrolment added.
01/08/2024: Uploaded protocol v10.0. The primary and secondary outcome measures and contact details were updated.
23/05/2024: The following changes were made to the trial record:
1. Uploaded protocol v9.0 (not peer-reviewed) as an additional file.
2. The participant information sheet v8.0 was uploaded as an additional file.
3. The intention to publish date was changed from 31/12/2025 to 30/11/2026.
4. The study participating centres Altnagelvin Area Hospital, Craigavon Area Hospital, Antrim Area Hospital, Salford Royal Hospital, Ninewells Hospital & Medical School,
13/05/2024: The recruitment end date was changed from 31/05/2024 to 31/08/2024.
26/06/2023: The following changes were made:
1. The recruitment end date was changed from 30/06/2023 to 31/05/2024.
2. The overall study end date was changed from 31/12/2023 to 31/08/2025.
3. The intention to publish date was changed from 31/12/2024 to 31/12/2025.
05/05/2023: The following changes have been made:
1. Publication reference added.
2. Protocol file uploaded.
14/07/2022: The recruitment end date was changed from 30/06/2022 to 30/06/2023.
30/12/2021: The recruitment end date was changed from 31/12/2021 to 30/06/2022.
17/02/2021: The recruitment end date was changed from 30/06/2021 to 31/12/2021.
09/02/2021: Contact details updated. Recruitment to this study is no longer paused.
23/03/2020: Internal review.
19/03/2020: Due to current public health guidance, recruitment for this study will be paused from 31/03/2020.
13/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2019 to 30/06/2021.
2. The overall trial end date has been changed from 31/12/2021 to 31/12/2023 and the plain English summary updated accordingly.
3. Northern General Hospital has been added to the trial participating centres.
4. The intention to publish date has been changed from 31/12/2022 to 31/12/2024.
5. The publication and dissemination plan has been changed.
02/07/2019: IPD sharing statement added.
01/07/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2019 to 31/12/2019.
2. The updated participant information sheet was uploaded.
3. The exclusion criteria, trial participating centres, and publication and dissemination plan were updated.
26/03/2019: The condition has been changed from "Specialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Other disorders of kidney and ureter" to "Renal failure" following a request from the NIHR.
05/07/2017: Trial website has been updated from http://bristol.ac.uk/prepare-me-trial to http://bristol.ac.uk/prepare-kc-trial. Secondary outcome measures have been updated.
