Clinical trial NCT06024655: Qualitative Study to Determine How Chronic Kidney Disease is Managed by Healthcare Professionals in Primary Care
Official title: Qualitative Study to Determine How Chronic Kidney Disease is Managed by Healthcare Professionals in Primary Care
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Kidney Diseases
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care professional working within the primary health care system, in the United Kingdom.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

Health care professional ( community based - doctor, nurse, healthcare assistant, pharmacist), working within primary care in the United Kingdom

Exclusion Criteria:

Non health care professionals Secondary care health care professionals.

Primary outcomes:
measure: Qualitative review of questionnaire submission and focus groups.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Imperial College London
name: Frederick W K Tam
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: RAKESH DATTANI
role: STUDY_CHAIR
affiliation: Imperial College London
name: Hutan Ashrafian
role: PRINCIPAL_INVESTIGATOR
References: