A quality improvement collaborative to scale up shared haemodialysis care for patients on centre based haemodialysis
| ISRCTN | ISRCTN93999549 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93999549 |
| Secondary identifying numbers | 31566 |
- Submission date
- 24/04/2017
- Registration date
- 02/05/2017
- Last edited
- 08/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Kidney failure has a major impact on quality of life and survical. In a healthy person, the kidneys are responsible for filtering out the waste products and excess water in the blood, and converting them into urine. When the kidneys fail, they stop cleaning the blood, leading to the build-up of harmful waste products. Haemodialysis (HD) is one of the most common treatments for kidney failure. It involves diverting the blood into an external machine so that it can be cleaned, before being returned to the body. In England approximately 20,000 people attend centres three times (totalling approximately 16 hours) per week to receive HD. Most are passive recipients of their care, engaging little with their own treatment.
Who can participate?
Adults who are being treated with haemodialysis in a participating centre
What does the study involve?
This is a study that only involves the completion of a number of questionnaires, and for those who agree, interviews. If the participant agrees, they are given a patient information sheet to keep and be asked to sign three copies of a consent form. Dialysis treatment will continue as normal. There are no extra hospital visits or medical tests and the study only examines the participant's usual care over 24 months. The participant is asked to complete a questionaire every three months to document the number of tasks relating to the dialysis treatment that they participate in themselves. In addition the participant is asked to complete three short questionnaires every six months to explore the relationship between the patient and their involvement in their own care and the outcomes and experience they have as a result of this. It also asks about quality of life, the care received and the journey to the dialysis centre. This information is linked to other data sources that provide more detailed health information including information on hospital admissions and other significant events. Completing the questionnaires is completely optional, and the participant can still participate in this study without completing these questionnaires. As part of the study, a deeper investigation into haemodialysis treatment is carried out using interviews and workshops with a small number of patients and carers. These individuals have the opportunity to indicate their interest complete additional consent for these interviews to be undertaken.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.
Where is the study run from?
12 dialysis centres (UK)
When is the study starting and how long is it expected to run for?
March 2016 to December 2018
Who is funding the study?
Health Foundation (UK)
Who is the main contact?
Professor Martin Wilkie
wilkieme@gmail.com
Contact information
Scientific
Sheffield Teaching Hospitals NHS Foundation Trust
Herries Road
Sheffield
S5 7AU
United Kingdom
 ORCID ID |
0000-0003-1059-6453 |
|---|---|
| Phone | +44 1142 715148 |
| wilkieme@gmail.com |
Study information
| Study design | Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A quality improvement collaborative to scale up Shared Haemodialysis Care for patients on centre based haemodialysis |
| Study acronym | ShareHD |
| Study objectives | Primary research question: To what extent does a programme of structured learning increase patient participation in haemodialysis activities or result in independent haemodialysis? Secondary research questions: 1. What are the economic consequences of introducing a programme of structured learning to increase patient involvement in haemodialysis? 2. In terms of encouraging patient involvement in haemodialysis, what works, for whom, in what circumstances and why? |
| Ethics approval(s) | London - West London & GTAC Research Ethics Committee; 06/09/2016, ref: 16/LO/1558 |
| Health condition(s) or problem(s) studied | Specialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Renal failure |
| Intervention | In this cohort study approximately 600 dialysis patients are recruited from 12 dialysis centres. Once consent has been taken patients will be given questionaires to complete that include demographics, a record of the number of dialysis related tasks that are being undertaken by the participant (3 monthly); a measure of patient activation, quality of life, renal symptom score, metacognition, confidence with self-needling and health literacy (6 monthly). In addition there is a 6 monthly health economic short questionaire, as status change form to be completed if the treatment type or location changes and a patient appreciation card. There are also interviews for a smaller number of patients and carers who indicate that they are interested in this part of the study. At the end of the study there will be data linkage with Hospital Episode Statistics to obtain hospitalisation and co-morbidity at the time of recruitment. The whole study lasts 2 years. |
| Intervention type | Other |
| Primary outcome measure | Whether or not HD patients can learn and complete 5 or more out of 14 tasks, is collected on paper forms for the 12 participating renal units over three, six-month duration, time periods or steps (Step 1 (baseline): 0 to 6 months, Step 2: 6 to 12 months; Step 3: 12 to 18 months. |
| Secondary outcome measures | 1. Number and proportion of HD patients who have Home HD or dialyse in centre independently will be measured by an event driven status change form that will identify when patients commence home haemodialysis and using information from the 3 monthly completed task summary sheets to determine whether patients are dialysing independently at dialysis centres 2. Economic evaluation will take an NHS and social care perspective and will compare Shared Haemodialysis Care with usual care in a cost-utility analysis using a cost-per quality adjusted life years (QALYs) approach at endline 3. Health related quality of life is assessed using the EQ-5D-5L at baseline, six and 12 months 4. Costs of the intervention will be collected throughout the study and will include set-up and running costs such as training, room hire, refreshments, materials, staff time, web site and staff |
| Overall study start date | 18/03/2016 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 586; UK Sample Size: 586 |
| Total final enrolment | 596 |
| Key inclusion criteria | 1. Established on centre based haemodialysis 2. Capacity to give written informed consent to participate in the study 3. Aged 18 years and over |
| Key exclusion criteria | 1. People who are too unwell to engage in the study, as judged by the clinical team 2. People unable to understand written and verbal communication in English 3. Unable to give informed consent |
| Date of first enrolment | 01/10/2016 |
| Date of final enrolment | 31/01/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Leeds
LS9 7TF
United Kingdom
Wolverhampton
WV10 0QP
United Kingdom
Manchester
M13 9WL
United Kingdom
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Stoke-on-Trent
ST4 6QG
United Kingdom
Birmingham
B9 5ST
United Kingdom
Stevenage
SG1 4AB
United Kingdom
London
SE1 9RT
United Kingdom
Nottingham
NG7 2UH
United Kingdom
York
YO31 8HE
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Sheffield
S5 7AU
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
England
United Kingdom
| Phone | +44 1142 714327 |
|---|---|
| Dipak.Patel@sth.nhs.uk | |
"ROR" |
https://ror.org/018hjpz25 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication of the results in peer reviewed scientific journals as well as other media such as patient magazines. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 24/11/2017 | Yes | No | |
| Results article | 20/07/2021 | 21/07/2021 | Yes | No | |
| Protocol file | version 1.3 | 27/07/2016 | 14/06/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | change in the prevalence of how individuals undergoing in-centre haemodialysis for kidney failure are affected by symptoms | 17/11/2023 | 08/07/2025 | Yes | No |
Additional files
Editorial Notes
08/07/2025: Publication reference added.
14/06/2023: Protocol uploaded (not peer reviewed).
21/07/2021: Publication reference added.
03/06/2020: Total final enrolment number added.
28/11/2017: Publication reference added
24/10/2017: The registration of this study was requested through the NIHR Portfolio. The trialist confirmed the recruitment start and end dates.
