Condition category
Urological and Genital Diseases
Date applied
24/04/2017
Date assigned
02/05/2017
Last edited
24/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

https://www.shareddialysis-care.org.uk

Contact information

Type

Scientific

Primary contact

Prof Martin Wilkie

ORCID ID

http://orcid.org/0000-0003-1059-6453

Contact details

Sheffield Teaching Hospitals NHS Foundation Trust
Herries Road
Sheffield
S5 7AU
United Kingdom
+44 1142 715148
wilkieme@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31566

Study information

Scientific title

A quality improvement collaborative to scale up Shared Haemodialysis Care for patients on centre based haemodialysis

Acronym

ShareHD

Study hypothesis

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

London - West London & GTAC Research Ethics Committee; 06/09/2016, ref: 16/LO/1558

Study design

Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

18/03/2016

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 586; UK Sample Size: 586

Participant 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

Recruitment start date

01/10/2016

Recruitment end date

31/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom

Trial participating centre

New Cross Hospital
Wolverhampton Road
Wolverhampton
WV10 0QP
United Kingdom

Trial participating centre

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Southmead Hospital
Southmead Road Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

Royal Stoke University Hospital
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

Trial participating centre

Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5ST
United Kingdom

Trial participating centre

Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom

Trial participating centre

Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Trial participating centre

Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

York Hospital
Wiggington Road
York
YO31 8HE
United Kingdom

Trial participating centre

Sunderland Royal Hospital
Kyall Road
Sunderland
SR4 7TP
United Kingdom

Trial participating centre

Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Foundation Trust

Sponsor details

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
+44 1142 714327
Dipak.Patel@sth.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Health Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/10/2017: The registration of this study was requested through the NIHR Portfolio. The trialist confirmed the recruitment start and end dates.