Overcoming barriers to research in patients with kidney disease
| ISRCTN | ISRCTN25504528 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25504528 |
| IRAS number | 341007 |
| Secondary identifying numbers | CPMS 62038, IRAS 341007, NIHR205362 |
- Submission date
- 02/08/2024
- Registration date
- 22/08/2024
- Last edited
- 09/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Kidney disease is a common condition that affects around 1 in every 10 adults over the age of 35 years. Most patients who currently agree to take part in research are mainly white, despite people from “underserved ethnic communities” – this means people who have been denied opportunities in society, partly because of their ethnicity in this case - are more likely to be diagnosed with kidney disease. Patients have been asked for their views about taking part in kidney research and they told us about different barriers such as differences in communication needs; understanding what research is; and concerns that research would interfere with their care. Indeed, non-English speaking patients were less likely to take part in the survey. The researchers believe that if these barriers can be addressed, it will help more people living with kidney disease participate in research. The study aims to develop a toolkit so the research team can engage with more people from these communities for future research projects.
Who can participate?
Patients with kidney disease aged 18 years or over from one of the six main ethnic communities served by the NCA Kidney Centre
What does the study involve?
Patients will be invited to participate in the interviews to establish a sample representing each of our main ethnic communities, with attention to the inclusion of a wide age range, sex balance and coverage of the centres, and main kidney treatment modalities (dialysis, transplant and non-dialysis chronic kidney disease patients). Participants will be involved in a 15-minute discussion with one of the research team members to hear more about the study, and so that participants can provide consent to participate. Then an informal 60-minute interview, with a research ambassador to discuss their views. In addition, members of the renal research team and other research teams around the NCA will be interviewed to understand their thoughts about diverse and underserved communities and obstacles that they think prevent greater engagement of diverse ethnic communities to participate in research.
What are the possible benefits and risks of participating?
Insights gained are expected to help research be more inclusive, which could benefit more people living with kidney disease in the future. No risks are envisaged.
Where is the study run from?
Northern Care Alliance NHS Foundation Trust
When is the study starting and how long is it expected to run for?
May 2024 to April 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) Research for Patient Benefit (RfPB) Programme
Who is the main contact?
Ivona Baricevic-Jones, Ivona.Baricevicjones@nca.nhs.uk
Contact information
Public
Northern Care Alliance NHS Foundation Trust
Salford Care Organisation
Salford Royal Hospital
Stott Lane
Salford
M6 8HD
United Kingdom
| hannah.howlett@nca.nhs.uk |
Scientific
Northern Care Alliance NHS Foundation Trust
Salford Care Organisation
Salford Royal Hospital
Stott Lane
Salford
M6 8HD
United Kingdom
| Ivona.Baricevicjones@nca.nhs.uk |
Study information
| Study design | Observational qualitative study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Qualitative study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Understanding and overcoming barriers to research involvement of patients with kidney disease from underserved communities |
| Study objectives | Can we understand the barriers that prevent people living with kidney disease from participating in research within our large catchment population of 1.55 million from a geographical area encompassing six ‘places’ in the integrated care system (ICS) structure |
| Ethics approval(s) |
Approved 16/05/2024, South West – Cornwall and Plymouth (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8071, (0)207 104 8079, (0)207 104 8143; cornwallandplymouth.rec@hra.nhs.uk), ref: 24/SW/0050 |
| Health condition(s) or problem(s) studied | Kidney disease |
| Intervention | The research participants will be identified by the direct care team who look after them. They will represent the different ethnic communities, all age groups and modalities of kidney treatment. The participants will be given an information sheet translated into their native language, and information about the study will be supplemented with a short video if required. Consent will be undertaken by the research team. The participant will then undergo a one-to-one meeting with a research ambassador in which a narrative interview will be undertaken. This will take place in the trust's premises and will be structured around a topic list. The interview will last for about 1 hour and will explore how their ethnic and cultural background influences their experience of kidney disease and engaging with clinical services and research; whether barriers to research participation exist and ways to overcome them; how they might be supported and encouraged to participate in future research. The responses to the participant will be recorded, with their permission. This will be the only encounter that the participant has in the research study. Interviews will be undertaken with around 10 members of the renal research team and 10 members of other research teams around the NCA to learn about their understanding of diverse and underserved communities; obstacles that they think prevent greater engagement and what would provide them with more confidence to approach patients from diverse ethnic community backgrounds to increase research engagement. |
| Intervention type | Other |
| Primary outcome measure | Stage 1. Research staff’s view on approaching patients from diverse backgrounds measured using a questionnaire at a single timepoint for each participant Stage 2. A nuanced understanding of the lived experiences of people from diverse ethnic communities relating to living with kidney disease, accessing healthcare, and participating in research measured using biographical interviews at a single timepoint for each participant Stage 3. Development of the toolkit for approach for research engagement and a targeted information campaign measured using data collected throughout the study |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/05/2024 |
| Completion date | 30/04/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 40; UK Sample Size: 40 |
| Key inclusion criteria | 1. 18 years of age or more 2. Patients with kidney disease under the care of the NCA kidney centre 3. Selected from one of the six main ethnic communities served by the NCA kidney centre |
| Key exclusion criteria | 1. <18 years of age 2. Lacking the cognitive capacity to consent to participate in the research |
| Date of first enrolment | 31/08/2024 |
| Date of final enrolment | 30/09/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Eccles
Salford
M6 8HD
United Kingdom
Sponsor information
Hospital/treatment centre
Salford Royal
Stott Lane
Salford
M5 5AP
England
United Kingdom
| Phone | +44 (0)7860531769 |
|---|---|
| RDResearch@nca.nhs.uk |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2026 |
|---|---|
| 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 in a peer-reviewed journal. Answers from the biographical interviews with patients will be used to design a toolkit for researchers to use in the future and for bespoke information campaigns directed to the communities to help patients with kidney disease take part in research. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
09/05/2025: The recruitment end date was changed from 31/05/2025 to 30/09/2025.
02/08/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
