Chronic Kidney DiseasesNCT05991726
A Delphi Survey for Key Stakeholders to Identify Priority Self-management Outcomes for Chronic Kidney Disease
An observational study of Chronic Kidney Diseases, run by University of Leicester at 1 site in United Kingdom.
Trial summary
The purpose of this Delphi study is to identify priority outcomes for self-management in earlier (non-dialysis) stages of CKD from the perspectives of different stakeholder groups in the UK. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Other: Survey
- How many people
- 140 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 May 2022to 3 Apr 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. People living with CKD. This survey focusses on people with non-dialysis CKD, typically stages 3-4. However, we will not exclude participation by those at a more advanced stage or receiving renal replacement therapy (dialysis or transplant) as these people also have lived experience of earlier stages to draw on. 2. Carers and Supporters of people with CKD (expected to be a significant other i.e. spouse or partner, close family member or friend that are involved in the regular care and support to a person living with CKD) 3. Healthcare professionals (HCPs) who look after people with CKD in the UK 4. Anyone involved in designing, developing, managing and commissioning of CKD healthcare in the UK 5. Researchers interested in self-management or CKD
Who may be able to join
- People with diagnosis of CKD in the UK
- Their close family and friend
- Healthcare professionals who look after people with CKD in the UK
- Anyone involved in designing, developing, managing and commissioning CKD healthcare services in the UK
- Researchers related in a topic related to self-management or CKD
Who cannot join
- Any participant residing outside of the UK
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Taking an Active Role in Your Own Healthcare: A Delphi Survey for Key Stakeholders to Identify Priority Self-management Outcomes for Chronic Kidney Disease (SM-CKD Delphi Study)
The purpose of this Delphi study is to identify priority outcomes for self-management in earlier (non-dialysis) stages of CKD from the perspectives of different stakeholder groups in the UK. The findings of this study will be used to inform outcome measure selection for research and clinical evaluations of self-management resources and to support implementation, commissioning and uptake.
Read the detailed description
Chronic Kidney Disease (CKD) is a progressive condition affecting more than 1.8 million people in England
Effective self-management is important for people living with CKD like many Long-Term Conditions. Self-management in its broadest term can be summarised as individuals participating in the day-to-day management of their chronic condition
Theory- and evidence-based tools and resources for self-management education and support are required to encourage health-promoting behaviours. However, outcomes valued by key stakeholders are necessary to ensure robust evaluation in research settings and clinical practice
A Delphi study is carried out to generate consensus on outcomes that are valued by the stakeholder groups in this study. The Delphi study will undergo 3-4 survey rounds
Adult CKD patient participants living in the UK and their significant others were recruited via social media adverts shared by our research team and English kidney community organisations. Healthcare professionals, commissioners and policymakers (professional groups) based in the UK were recruited by direct email invitations to our extensive contacts in the field
- Conditions
- Chronic Kidney Diseases
- Being tested
- Other: Survey
- Keywords
- Survey, Chronic Kidney disease, Stakeholder
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: SurveyOther
Multiple survey rounds identifying most important outcomes for effective self-management for non-dialysis CKD
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Professional Expert | This includes Healthcare professionals (HCPs) who look after people with CKD in the UK, anyone involved in designing, developing, managing and commissioning of CKD healthcare in the UK and researchers interested in self-management or CKD Receives: Other: Other: Survey | |
| Cohort 2: Non-Professional Expert | This stakeholder group comprised individuals living with chronic kidney disease (CKD) and informal caregivers (e.g., family members or significant others). Caregivers were not analyzed as a separate study arm due to the small number enrolled and overlap in roles, as some participants with CKD also identified as caregivers. For analytic purposes, responses were therefore combined into a single pre-specified stakeholder category representing lay or non-professional expertise. This combined reporting approach reflects established methodology in CKD Delphi studies, including those conducted by the Standardised Outcomes in Nephrology (SONG) initiative. This grouping does not represent an additional intervention or control arm, but rather a stakeholder classification used solely for descriptive and consensus analyses. Receives: Other: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Open Ended Free Text Question (Identifying Stakeholder Views on the 3 Most Important Outcomes for Self-management)
Round 1- Participants are asked to describe the 3 most important outcomes for self-management in people with non-dialysis CKD from their own perspective or opinion
Measured: Between 3 to 6 month
Consensus Rating (Rating Each Item for Importance)
Round 2- Participants are asked to rate each item on a 9 point Likert-type scale, ranging from 1 (not important) to 9 (critically important). Higher scores indicate greater perceived importance of the item.
Items were analysed individually; no total or subscale scores were calculated. For each item, the distribution of ratings and mean score were computed.
Consensus was predefined as at least 70% of participants rating an item between 7 and 9 (critical importance), or a mean score of ≥7. Items not meeting this threshold were removed in subsequent Delphi rounds.
Measured: Between 3 to 6 month
Consensus Ranking (Ranking Items to Identify Top 3 Items)
Round 3- Participants are asked to rank each item and themes in order from high to low importance to identify the most valued outcomes
Measured: Between 3 to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start5 May 2022
- Primary completion3 Apr 2023
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991726
- Sponsor's protocol ID
- 33721
- Status last verified
- Jan 2026
- First submitted
- 7 Aug 2023
- Last updated
- 30 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taking an Active Role in Your Own Healthcare: A Delphi Survey for Key Stakeholders to Identify Priority Self-management Outcomes for Chronic Kidney Disease (SM-CKD Delphi Study)
- ClinicalTrials.gov ID
- NCT05991726
- Acronym / sponsor ID
- 33721
- Conditions
- Chronic Kidney Diseases
- Keywords
- Survey, Chronic Kidney disease, Stakeholder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Posted 30 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Delphi study is to identify priority outcomes for self-management in earlier (non-dialysis) stages of CKD from the perspectives of different stakeholder groups in the UK. The findings of this study will be used to inform outcome measure selection for research and clinical evaluations of self-management resources and to support implementation, commissioning and uptake.
Detailed description
Chronic Kidney Disease (CKD) is a progressive condition affecting more than 1.8 million people in England
Effective self-management is important for people living with CKD like many Long-Term Conditions. Self-management in its broadest term can be summarised as individuals participating in the day-to-day management of their chronic condition
Theory- and evidence-based tools and resources for self-management education and support are required to encourage health-promoting behaviours. However, outcomes valued by key stakeholders are necessary to ensure robust evaluation in research settings and clinical practice
A Delphi study is carried out to generate consensus on outcomes that are valued by the stakeholder groups in this study. The Delphi study will undergo 3-4 survey rounds
Adult CKD patient participants living in the UK and their significant others were recruited via social media adverts shared by our research team and English kidney community organisations. Healthcare professionals, commissioners and policymakers (professional groups) based in the UK were recruited by direct email invitations to our extensive contacts in the field
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Professional Expert | – | Other: Other: SurveyThis includes Healthcare professionals (HCPs) who look after people with CKD in the UK, anyone involved in designing, developing, managing and commissioning of CKD healthcare in the UK and researchers interested in self-management or CKD |
| Cohort 2: Non-Professional Expert | – | Other: Other: SurveyThis stakeholder group comprised individuals living with chronic kidney disease (CKD) and informal caregivers (e.g., family members or significant others). Caregivers were not analyzed as a separate study arm due to the small number enrolled and overlap in roles, as some participants with CKD also identified as caregivers. For analytic purposes, responses were therefore combined into a single pre-specified stakeholder category representing lay or non-professional expertise. This combined reporting approach reflects established methodology in CKD Delphi studies, including those conducted by the Standardised Outcomes in Nephrology (SONG) initiative. This grouping does not represent an additional intervention or control arm, but rather a stakeholder classification used solely for descriptive and consensus analyses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. People living with CKD. This survey focusses on people with non-dialysis CKD, typically stages 3-4. However, we will not exclude participation by those at a more advanced stage or receiving renal replacement therapy (dialysis or transplant) as these people also have lived experience of earlier stages to draw on. 2. Carers and Supporters of people with CKD (expected to be a significant other i.e. spouse or partner, close family member or friend that are involved in the regular care and support to a person living with CKD) 3. Healthcare professionals (HCPs) who look after people with CKD in the UK 4. Anyone involved in designing, developing, managing and commissioning of CKD healthcare in the UK 5. Researchers interested in self-management or CKD
Key inclusion criteria (5 listed)
- People with diagnosis of CKD in the UK
- Their close family and friend
- Healthcare professionals who look after people with CKD in the UK
- Anyone involved in designing, developing, managing and commissioning CKD healthcare services in the UK
- Researchers related in a topic related to self-management or CKD
Key exclusion criteria (1 listed)
- Any participant residing outside of the UK
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other: SurveyMultiple survey rounds identifying most important outcomes for effective self-management for non-dialysis CKD | Other | Cohort 1: Professional Expert, Cohort 2: Non-Professional Expert |
Primary outcome
Open Ended Free Text Question (Identifying Stakeholder Views on the 3 Most Important Outcomes for Self-management)
Time frame: Between 3 to 6 month
Round 1- Participants are asked to describe the 3 most important outcomes for self-management in people with non-dialysis CKD from their own perspective or opinion
Consensus Rating (Rating Each Item for Importance)
Time frame: Between 3 to 6 month
Round 2- Participants are asked to rate each item on a 9 point Likert-type scale, ranging from 1 (not important) to 9 (critically important). Higher scores indicate greater perceived importance of the item. Items were analysed individually; no total or subscale scores were calculated. For each item, the distribution of ratings and mean score were computed. Consensus was predefined as at least 70% of participants rating an item between 7 and 9 (critical importance), or a mean score of ≥7. Items not meeting this threshold were removed in subsequent Delphi rounds.
Consensus Ranking (Ranking Items to Identify Top 3 Items)
Time frame: Between 3 to 6 month
Round 3- Participants are asked to rank each item and themes in order from high to low importance to identify the most valued outcomes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by University of Leicester at 1 site in United Kingdom.
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 5 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: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 30 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Open Ended Free Text Question (Identifying Stakeholder Views on the 3 Most Important Outcomes for Self-management) (time frame: Between 3 to 6 month). The study lists 3 primary outcomes in all. 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 30 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.