Chronic Kidney DiseasesNCT06024655
Qualitative Study to Determine How Chronic Kidney Disease is Managed by Healthcare Professionals in Primary Care
An observational study of Chronic Kidney Diseases, run by Imperial College London.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Health care professional working within the primary health care system, in the United Kingdom.
Who may be able to join
- Health care professional ( community based - doctor, nurse, healthcare assistant, pharmacist), working within primary care in the United Kingdom
Who cannot join
- Non health care professionals Secondary care health care professionals.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative review of questionnaire submission and focus groups.
This is a qualitative study, with qualitative methods applied to analyse the data generated. The qualitative data analysis approach will systematise descriptive data collected through the online questionnaire and subsequent focus groups, with the aim being to identify patterns and themes behind the interviews, surveys, and observations and interpreting it. The method aims to identify patterns and themes behind textual data. Specific analysis undertaken will utilise: 1. Discourse analysis whereby we will review the received answers from the questionnaire and the transcript form the focus groups to determine relationships between the received information and its context. 2. Conversion of qualitative data within the online questionnaire to quantitative data to allow for conclusions to be made 3. Thematic anlaysis for the transcript of the focus group to identify themes on how patients feel their care could have been improved upon.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederick W K Tam, Principal investigator, Imperial College LondonRAKESH DATTANI, Study chair, Imperial College LondonHutan Ashrafian, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024655
- Sponsor's protocol ID
- 22IC7495
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD data to be shared, solely aggregated data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Study to Determine How Chronic Kidney Disease is Managed by Healthcare Professionals in Primary Care
- ClinicalTrials.gov ID
- NCT06024655
- Acronym / sponsor ID
- 22IC7495
- Conditions
- Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Health care professional working within the primary health care system, in the United Kingdom.
Key inclusion criteria (1 listed)
- Health care professional ( community based - doctor, nurse, healthcare assistant, pharmacist), working within primary care in the United Kingdom
Key exclusion criteria (1 listed)
- Non health care professionals Secondary care health care professionals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative review of questionnaire submission and focus groups.
Time frame: 6 months
This is a qualitative study, with qualitative methods applied to analyse the data generated. The qualitative data analysis approach will systematise descriptive data collected through the online questionnaire and subsequent focus groups, with the aim being to identify patterns and themes behind the interviews, surveys, and observations and interpreting it. The method aims to identify patterns and themes behind textual data. Specific analysis undertaken will utilise: 1. Discourse analysis whereby we will review the received answers from the questionnaire and the transcript form the focus groups to determine relationships between the received information and its context. 2. Conversion of qualitative data within the online questionnaire to quantitative data to allow for conclusions to be made 3. Thematic anlaysis for the transcript of the focus group to identify themes on how patients feel their care could have been improved upon.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No. No IPD data to be shared, solely aggregated data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick W K Tam principal investigator
Imperial College London
RAKESH DATTANI study chair
Imperial College London
Hutan Ashrafian principal investigator
Imperial College London
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RAKESH DATTANI, MBBS (020 3313 1000, rakesh.dattani@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative review of questionnaire submission and focus groups. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.