LINK-UP: novel interventions in kidney disease - user perspectives
| ISRCTN | ISRCTN28607041 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28607041 |
| IRAS number | 346105 |
| Secondary identifying numbers | CPMS 64972, NIHR303940 |
- Submission date
- 27/05/2025
- Registration date
- 22/10/2025
- Last edited
- 22/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Kidney disease affects more than 1 in 10 adults in the UK and can lead to serious health problems like kidney failure, heart disease, and fatigue. It can also make everyday life harder due to strict diets, medications, and reduced physical ability.
To help people manage their kidney health, a digital tool called "My Kidneys & Me" was created with input from patients and healthcare professionals. It gives personalised information and support to help people better understand and manage their condition. A previous study showed that this tool helped people feel more confident about managing their kidney disease.
However, it can be difficult to make tools like this part of everyday healthcare. This study aims to find out what helps or gets in the way of creating and using lifestyle and wellbeing support for people with kidney disease. Researchers will speak to patients, carers, healthcare staff, and others to learn how to make future tools more effective, inclusive, and easier to use.
Who can participate?
Adults aged 18 or over can take part if they:
- Have been diagnosed with kidney disease, or think they might have it (eligibility will be checked)
- Are a relative, friend, or carer of someone with kidney disease
- Work with kidney patients (for example, healthcare staff, charity workers, service managers)
- Have experience or knowledge of kidney disease through another role
People who are not connected to kidney disease in any way, or who cannot give informed consent, cannot take part.
What does the study involve?
If you take part, you’ll be asked to share your thoughts and experiences in one of the following ways:
- A one-to-one interview
- A “think aloud” interview, where you talk through your thoughts while using or reviewing something
- A group discussion (focus group) with others
You’ll also be asked to fill out a short online survey before the interview. The questions will be flexible so you can speak freely and openly.
What are the possible benefits and risks of participating?
Risks:
- The interview or group discussion will take up to 1 to 1.5 hours.
- Talking about personal experiences might be upsetting. You can pause, skip questions, or stop at any time.
- If you seem distressed, the interviewer will check in with you and may suggest speaking to your GP. If something serious comes up (like a safety concern), the research team may need to share that information, but they will try to let you know first.
Benefits:
- You’ll receive a 30 pound gift voucher as a thank you.
- If you attend in person, your travel costs will be paid back.
- You’ll be helping to improve support and services for people with kidney disease.
Where is the study run from?
The study is based at the University of Leicester and Leicester General Hospital. Interviews can be done in person at these locations or online via video call.
When is the study starting and how long is it expected to run for?
March 2025 to June 2029.
Who is funding the study?
Stoneygate Trust (UK)
Who is the main contact?
Gurneet Kaur Sohansoha, Clinical Trials Coordinator
gks46@leicester.ac.uk
Contact information
Public, Scientific, Principal Investigator
Leicester Royal Infirmary, Infirmary Square
Leicester
LE1 5WW
United Kingdom
| Phone | +44 1162584346 |
|---|---|
| gurneet.sohansoha@uhl-tr.nhs.uk |
Study information
| Study design | Observational qualitative |
|---|---|
| Primary study design | Observational |
| Secondary study design | Qualitative research |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | noveL InterveNtions in Kidney disease - User Perspectives |
| Study acronym | LINK-UP |
| Study objectives | To understand the user perspectives and experiences, barriers and facilitators to the design, development, evaluation, and implementation of novel interventions for people with kidney disease including health, wellbeing and lifestyle interventions. Users may include but not limited to patients, carers or support, clinicians, administrative staff, any healthcare professionals and similar, commissioners, service managers, charity representatives or any other stakeholder group. |
| Ethics approval(s) |
Approved 04/04/2025, West Midlands - Edgbaston Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048137; edgbaston.rec@hra.nhs.uk), ref: 25/WM/0060 |
| Health condition(s) or problem(s) studied | Kidney disease |
| Intervention | LINK-UP is a qualitative study. This involves speaking in depth with researchers about their experiences and opinions. This may take the form of a one-to-one interview or a focus group with a few other participants. Discussions may be conducted via telephone, video call, or in person at an appropriate venue. All interviews and focus groups will be led by an experienced researcher trained in qualitative research methods. Discussions will be digitally recorded, professionally transcribed verbatim (written up word-for-word), anonymised, and translated where necessary. They will be analysed using appropriate qualitative methodologies to explore different perspectives on the barriers and facilitators to the successful implementation of lifestyle interventions for patients with kidney disease (KD), and to identify processes that support successful implementation. This study will recruit participants with KD, their significant others and non-professional carers, healthcare professionals or similar, commissioners, policy makers, charity organisations, and other stakeholders involved in the care of kidney patients, kidney service design, planning and delivery, or the wider kidney community. We plan to recruit a total of at least 50 participants. This will be a multi-centre study, with patients recruited from both primary care (for example, first point of contact such as GPs) and secondary care (for example, those who see a specialist kidney doctor). The University Hospitals of Leicester (UHL) will be the hosting NHS site. Patients in secondary care will be recruited from KD clinics at UHL by screening clinic lists prior to approaching the patient. Patients from primary care will be recruited from primary care CKD clinics (LUCID clinics – the Leicester, Leicestershire and Rutland virtual CKD clinic, which is a UHL service supporting the management of patients with CKD in primary care with specialist secondary care consultant input). Additionally, the study will be advertised through local, regional, and national groups and on social media so participants will be able to self-refer from outside of Leicester, Leicestershire and Rutland to take part in the study by contacting the study team directly. The study will also allow patients with a kidney condition to refer a significant other of their choice to take part in the study if they would like to. Participants will be recruited after being sent an information sheet and completing a consent form. If they then wish to proceed, they will be informed to contact the research team directly by a method of their choosing (email, phone or face-to-face). The researcher will answer any questions and arrange a suitable date, time and venue for the interview, allowing at least 24 hours after reading the information sheet. To gather some basic information on whom we interview, we will ask participants to complete a short survey online. This will be completed before the interview. The survey asks about age, gender, ethnicity, and the connection to a person (or persons) with a kidney condition. If participants are unable to fill this in or experience difficulty, a researcher will be able to assist them before the interview takes place. |
| Intervention type | Other |
| Primary outcome measure | Qualitative analysis of transcripts from conducted interviews and focus groups investigating user perspectives of novel interventions in kidney disease |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 03/03/2025 |
| Completion date | 29/06/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 50; UK Sample Size: 50 |
| Key inclusion criteria | Inclusion criteria for CKD patients referred from a clinic and/or by HCP: 1.Patients with established KD according to the National Institute for Health and Care Excellence (NICE) guidelines 2.Aged 18 and above 3.Willing and able to give informed consent and comply with the study protocol Inclusion criteria for self-referred CKD patients: 1.Patients perceived to have a kidney condition or progressive kidney disease 2.Aged 18 and above 3.Willing and able to give informed consent and comply with the study protocol Inclusion criteria for non-CKD patients: 1.Participant does not have a kidney condition, but is affected by it as a relative, friend, or spouse of someone living with a kidney condition OR 2.Participant is involved in the care and management of people with a kidney condition OR 3.Participant has knowledge or experience of kidney disease in some other capacity (e.g., charities or other support organisations) 4.Aged 18 or above 5.Willing and able to give informed consent and comply with the study protocol |
| Key exclusion criteria | Exclusion criteria for CKD patients: 1. Patients without established KD according to NICE guidelines 2. Inability to give informed consent or comply with the protocol for any reason Exclusion criteria for non-CKD patients: 1. Is not associated, has no relationship or provide care to someone with a kidney condition 2.Inability to give informed consent or comply with the protocol for any reason |
| Date of first enrolment | 27/05/2025 |
| Date of final enrolment | 30/06/2028 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Sponsor information
University/education
University Road
Leicester
LE1 7RH
England
United Kingdom
| Phone | +44 1162736508 |
|---|---|
| rgosponsor@leicester.ac.uk | |
| Website | https://le.ac.uk |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 | They will be presented at scientific and medical conferences as short summaries (called abstracts).The findings will also be written up and published in medical journals that are reviewed by experts. Everyone who made a meaningful contribution to the study will be listed as an author, and others involved will be acknowledged with their permission. All reports and publications will be carefully reviewed and approved by the Chief Investigator (CI), who is responsible for the study data. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
27/05/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
