Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06024655 |
| Other study ID # |
22IC7495 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
April 1, 2024 |
Study information
| Verified date |
August 2023 |
| Source |
Imperial College London |
| Contact |
RAKESH DATTANI, MBBS |
| Phone |
020 3313 1000 |
| Email |
rakesh.dattani[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The prevalence of Chronic Kidney Disease is rising worldwide exponentially on account of a
rising prevalence of the commonest causes of patients developing CKD. For instance, the
prevalence of Type 2 diabetes, the commonest cause of CKD worldwide, is increasing with an
expected 450 million people expected to have type 2 diabetes by 2030. Poorly controlled blood
sugars are associated with a risk of complications related to the eyes, heart and kidneys
amongst other organs, resulting in poor long-term health and quality of life. The kidney is
one of the most frequently affected organs, with diabetes related kidney disease (DKD) the
commonest cause of kidney failure worldwide, with patients requiring dialysis and
transplantation to survive. However, despite transplantation allowing patients to live life's
without the need for dialysis, diabetes remains to be associated with poor transplant
function, cardiovascular disease and overall poor quality of life. With primary care being
instrumental in the screening, diagnosis and management/monitoring of CKD, this study aims to
identify areas done well as well as areas where improvement is needed to improve a patients
clinical journey and management. This will be done in the form of an online questionnaire and
focus groups, advertised via clinical commissioning groups across the United Kingdom. Through
this, the investigators hope to gain further insight into areas of clinical management done
well and areas of improvement as well as how primary care feel current management could be
improved upon, obstacles faced, additional resources required and how they could be better
supported by hospital specialists. Study results will be analysed and published in a peer
reviewed journal with recommendations made with regards to how care should be altered to help
delay and prevent CKD onset and progression.
Description:
The study is designed in the form of a clinician validated online questionnaire (conducted
via Qualitrics.com), with participants recruited anonymously. Integrated care boards (ICB)
from across the country will be sent an online link to the questionnaire via email and
encouraged to share amongst clinicians and allied health care providers within their ICB.
Where participants open the study web address (via an anonymous link or QR code) they will be
taken to the participant information sheet which aims to provide potential participants with
more information regarding the study, its aims, benefits, risks and potential conflicts of
interests. Participants will then be asked to consent to the study online following which
they will be asked to complete an online questionnaire, which aims to take participants no
more than fifteen minutes to complete. As an added non obligatory component, participants who
complete the study, will be asked if they are willing to partake in an online focus group of
uptown 6 participants in the future, to further discuss the study and gain a further
understanding of factors which would empower participants to improve their individual health
and diabetes control. Those participants will be asked to provide a contact email address, in
order for the study organisers to make contact with the participant with regards to potential
focus groups in the future. Participation is completely voluntary and participants may change
their decision at any time. Participants will be consented again for their participation in
the focus groups electronically prior to the focus group.Focus groups will be conducted via
Microsoft Teams and will concentrate on key findings of the online questionnaire data to
further understand clinician perspectives of how diabetes is currently managed and ways in
which care could be improved upon. They will be of no longer than 60 minutes in duration
each.
Focus groups will be audio recorded and be transcribed by the study organisers within 7 days
of the focus group, following which the recording will be deleted. Transcribed focus groups
will be anonymised and will be stored electronically at Imperial College London in a password
protected file. Data will be analysed and submitted in the form of a research paper to a peer
reviewed scientific journal.
