RePROM pilot/feasibility study in chronic kidney disease
| ISRCTN | ISRCTN12669006 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12669006 |
| Secondary identifying numbers | 36497 |
- Submission date
- 19/02/2018
- Registration date
- 28/02/2018
- Last edited
- 13/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Chronic kidney disease (CKD) affects around 1 in 7 people in the UK. Some people with advanced CKD may go on to need demanding treatments such as dialysis, which can affect their quality of life. Some researchers and doctors believe it would be helpful for patients to provide reports about their symptoms and quality of life in between their regular hospital appointments by completing a questionnaire on their computer or smartphone. These questionnaires are called ‘electronic Patient-Reported Outcome Measures’ or ePROMs. If the ePROM report shows that a patient needs urgent care, this will help a doctor take action straight away, rather than waiting until the next clinic appointment. This could help to manage a patient’s CKD and symptoms better. No-one has tried using ePROM reporting for people with CKD, so the aim of this study is to test an ePROM system in a small group of patients with CKD who are being treated at the Queen Elizabeth Hospital in Birmingham. The results will be used to plan a much larger study to show whether ePROM reporting in the NHS is actually better for patients.
Who can participate?
Patients who are over 18 and have advanced chronic kidney disease
What does the study involve?
Participants are randomly allocated to one of two groups. One group continue to receive usual care, while the other group are asked to provide monthly reports on their health status using an online electronic Patient-Reported Outcome Measure (ePROM) system.
What are the possible benefits and risks of participating?
It is not known whether using the ePROM system will have any benefits. Participants in the ePROM group might benefit from being more closely monitored by the CKD team, but this study is needed to find this out. If the ePROM reporting system is shown to be helpful in a large study, future patients with advanced CKD may benefit from its use across the NHS. There are no risks to taking part in the study, only the use of participants' time. For participants in both groups, the extra information collected for this study will make their appointments a little longer.
Where is the study run from?
The study is being run by the University of Birmingham. Participants will be recruited at the Queen Elizabeth Hospital, Birmingham (UK)
When is the study starting and how long is it expected to run for?
January 2017 to December 2020
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Derek Kyte
d.kyte@worc.ac.uk
Contact information
Public
School of Allied Health and Community
University of Worcester
St John’s Campus Henwick Grove
Worcester
WR2 6AJ
United Kingdom
 ORCID ID |
0000-0002-7679-6741 |
|---|---|
| d.kyte@worc.ac.uk |
Study information
| Study design | Randomized; Both; Design type: Treatment, Complex Intervention, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The use of an electronic Patient-Reported Outcome Measure in the management of patients with advanced chronic kidney disease – the RePROM pilot trial |
| Study acronym | RePROM |
| Study objectives | To assess the feasibility of undertaking a randomised controlled trial (RCT) of the use of electronic Patient-Reported Outcomes (ePROMs) in the management of patients with advanced Chronic Kidney Disease (CKD). |
| Ethics approval(s) | West Midlands - Edgbaston Research Ethics Committee, 26/02/2018, ref: 18/WM/0013 |
| Health condition(s) or problem(s) studied | Advanced Chronic Kidney Disease |
| Intervention | Participants randomised to the intervention arm will commence monthly self-reporting of their health status using an online electronic Patient-Reported Outcome (ePROM system), after receiving a face-to-face training session. Reporting will continue for 12 months. Participants will receive automated reminders 24 hours prior to each scheduled self-report and 24 hours after a failure to report if necessary, these will be delivered via the secure hospital patient portal, text message, email or a landline telephone call, according to participants’ preferences. Participants may also upload additional ad-hoc reports to the system as well, if they feel this is necessary (e.g.: if they wish to communicate a sudden change in symptoms). The ePROM system will provide tailored information to patients in response to each report (both scheduled and ad-hoc) and alert the clinical team of patient deterioration according to a priori determined alert threshold criteria established in the trial intervention development study. After receiving training during the study setup period, the renal clinical team will monitor for ePROM alerts and will respond with appropriate clinical action, in line with standard clinical practice. Participants randomised to the control group continue to receive usual care. |
| Intervention type | Other |
| Primary outcome measure | Feasibility is measured via review of recruitment and retention rates, data collection processes, data completeness and adherence to the ePROM intervention, at the end of the trial |
| Secondary outcome measures | 1. Health-related quality of life is measured using the validated EQ-5D-5L at baseline, 3, 6 9 and 12 months 2. Clinical condition is measured using: Serum Creatinine, Calcium, Phosphate, Bicarbonate, Albumin, eGFR, ACR, blood pressure, and for participants with diabetes: glucose and HbA1c, at baseline, 3, 6 9 and 12 months 3. Clinical event data, including: progression to end stage renal disease, contact with health care professionals in secondary care (outpatient clinics and A&E), inpatient hospitalisation and death, are measured using Clinical Report Forms at baseline, 3, 6 9 and 12 months 4. Health resource use data are measured using Clinical Report Forms at baseline, 3, 6 9 and 12 months |
| Overall study start date | 01/01/2017 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 66; UK Sample Size: 66 |
| Total final enrolment | 66 |
| Key inclusion criteria | 1. Aged ≥18 years old 2. Ability to provide fully informed consent for participation in the study 3. Patients under the care of the renal services at Queen Elizabeth Hospital Birmingham (QEHB) 4. Patients meeting the trial definition of advanced CKD: an eGFR ≥6 and ≤15 mL/min/1.73m2 (inclusive) OR a projected risk of progression to end-stage renal failure within 2-years ≥20% using the 4-variable Tangri renal risk calculator |
| Key exclusion criteria | 1. Patients unwilling to use the ePROM intervention 2. Patients who, in the opinion of the consenting professional, cannot speak, read or write English sufficiently well to complete the ePROM unaided 3. An episode of acute kidney injury (defined in accordance with national guidelines) within the last 3 months 4. Patients meeting the trial definition of End Stage Renal Disease (currently receiving dialysis/scheduled to start in the next 2 weeks OR received/scheduled date to receive a kidney transplant OR eGFR < = 5ml/min/1.73m2) 5. A terminal illness that, in the opinion of the consultant consultant assessing eligibility, is likely to lead to the death of the patient within 6 months of starting participation in the study |
| Date of first enrolment | 31/10/2018 |
| Date of final enrolment | 04/04/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Sponsor information
Hospital/treatment centre
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
"ROR" |
https://ror.org/03angcq70 |
|---|
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 | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 11/12/2020: Planned publication in a high-impact peer-reviewed journal. Additional trial documents will be made available on the study website at: https://www.birmingham.ac.uk/RePROM Previous publication and dissemination plan: Planned publication in a high-impact peer-reviewed journal. Additional trial documents will be made available on the study website at: https://www.birmingham.ac.uk/RePROM |
| IPD sharing plan | Current IPD sharing statement as of 11/12/2020: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request Previous IPD sharing statement: The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 28/10/2018 | 11/12/2020 | Yes | No |
| Results article | 18/03/2022 | 13/03/2023 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
13/03/2023: Publication reference added.
31/01/2023: Contact details updated.
11/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The recruitment start date was changed from 01/04/2018 to 31/10/2018.
3. The recruitment end date was changed from 01/04/2020 to 04/04/2020.
4. The publication and dissemination plan was changed.
5. The participant level data was changed from Other to Available on request.
27/03/2019: The condition has been changed from "Specialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Renal failure" to "Advanced Chronic Kidney Disease" following a request from the NIHR.
