Online education self-management programme in people with kidney disease
| ISRCTN | ISRCTN18314195 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18314195 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 282573 |
| Protocol serial number | IRAS 282573, CPMS 47222 |
| Sponsor | University of Leicester |
| Funder | Leicester Biomedical Research Centre |
- Submission date
- 15/12/2020
- Registration date
- 18/12/2020
- Last edited
- 15/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
People living with kidney problems (or chronic kidney disease [CKD]) need to look after their own health until they reach the need for dialysis or a kidney transplant, which most patients will never require. Having a healthy lifestyle can help people with CKD live a good quality of life and potentially slow disease progression. However, many people with CKD do not know about their condition, its treatment, or how to look after their health. To manage health effectively, patients need to have the knowledge, confidence and skills to take on this role. This is called ‘patient activation’. The researchers have developed an online educational programme aiming to improve CKD patients’ knowledge, confidence and skills to look after their own health. The aim of this study is to find out whether this will increase patient activation.
Who can participate?
Patients aged 18 or older with diagnosed kidney disease who have not had a transplant or who need dialysis treatment. Participants will be invited from different sites around England.
What does the study involve?
Part A is the main trial, where patients will be randomly allocated into either a group receiving access to the programme, or a control group who will not receive the programme until the end. The main aim is to measure the effect of the programme on patient activation. The researchers will also assess how many people are recruited if patients follow the programme as intended, how many people in both groups drop out, if people fill in the questionnaires as intended, and safety. This part of the study is run online.
Part B is split into two smaller studies; each includes a small sample of those taking part in Part A. Part B1 is a visit to the hospital to assess the participant's physical abilities before and after the programme. Part B2 is an interview (either in person or over the phone) with a researcher, firstly to explore patient thoughts of the programme and how they found taking part.
What are the possible benefits and risks of participating?
There are no direct benefits of taking part in the study, although it is hoped that the programme will improve participants' knowledge, confidence and skills in managing their own health. There are no risks to taking part. Part A is online, and participants can engage with the programme as they want. Part B involves some simple tests of physical function.
Where is the study run from?
University Hospitals of Leicester (UK)
When is the study starting and how long is it expected to run for?
November 2020 to December 2022
Who is funding the study?
Leicester Biomedical Research Centre (UK)
Who is the main contact?
Prof. Alice Smith
aa50@le.ac.uk
Contact information
Scientific
Department of Health Sciences
University of Leicester
Leicester
LE17RH
United Kingdom
| Phone | +44 (0)116 373 6425 |
|---|---|
| aa50@le.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind longitudinal randomized control trial with nested feasibility study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Self-Management Intervention through Lifestyle Education for Kidney health |
| Study acronym | SMILE-K |
| Study objectives | It is hypothesised that a structured online self-management programme - ‘My Kidneys & Me’ - will increase patient activation levels. |
| Ethics approval(s) | 1. Approved 13/11/2020, East Midlands – Leicester South Research Ethics Committee (Marriott Road, Leicester, LE2 6NT, UK; +44 (0)207 104 8193; Leicestersouth.rec@hra.nhs.uk), ref: 20/EM/0252 2. Approved 19/11/2020, East Midlands - Leicester South Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 1048310; leicestersouth.rec@hra.nhs.uk), ref: 17/EM/0357 |
| Health condition(s) or problem(s) studied | Chronic kidney disease |
| Intervention | Patients will be randomised 2:1 into either an intervention group or usual care (control) group. The intervention group will have access to ‘My Kidneys & Me’ – an online self-management educational programme aimed to increase patient activation and self-management behaviours. The programme consists of educational sessions released weekly for 10-weeks as well as tools to track physical activity, symptoms, and diet. The usual care group will not have access to the programme, although they will be offered access for 2 years once they have finished in the study. Outcomes will be assessed at baseline, week 10, and week 20. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Patient activation assessed using the Patient Activation Measure (PAM-13) at baseline, week 10, and week 20 |
| Key secondary outcome measure(s) |
Measured at baseline, week 10, and week 20: |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 432 |
| Total final enrolment | 465 |
| Key inclusion criteria | 1. Individuals aged 18 years or older 2. Established CKD stage 3-4 (eGFR of 15-59 ml/min/1.73m²) according to the NICE guidelines |
| Key exclusion criteria | Those requiring any form of renal replacement therapy (i.e. any modality of dialysis, or transplantation) or with insufficient command of English or any other precluding factors that prevent ability to give informed consent or comply with protocol |
| Date of first enrolment | 01/02/2021 |
| Date of final enrolment | 01/02/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leicester
LE4 5PW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the research team (Prof. Alice Smith, aa50@le.ac.uk). The type of anonymous data requested will be considered on a case-by-case basis. The researchers expect data to be available in 2023. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/11/2024 | 15/11/2024 | Yes | No | |
| Protocol article | 16/11/2022 | 18/11/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | internal pilot results assessing feasibility and acceptability against pre-specified progression criteria | 31/01/2024 | 06/02/2024 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/11/2024: Publication reference added.
06/02/2024: Publication reference added.
31/01/2024: The intention to publish date was changed from 31/12/2023 to 31/10/2024.
30/01/2024: Ethics approval details and total final enrolment added.
18/11/2022: Publication reference added.
17/12/2020: Trial's existence confirmed by East Midlands - Leicester South Research Ethics Committee.
