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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other: Survey | Other | Multiple survey rounds identifying most important outcomes for effective self-management for non-dialysis CKD |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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 | Between 3 to 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leicester | Leicester | LE1 7RH | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Other: Survey: Multiple survey rounds identifying most important outcomes for effective self-management for non-dialysis CKD |
| FG001 | 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 analysed 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 in Delphi studies. Other: Survey: Multiple survey rounds identifying most important outcomes for effective self-management for non-dialysis CKD |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This number differs from overall participants as some individuals initially enrolled on the study but only provided their contact details to participate in further rounds and did not engage in the study activities for data analysis. The number above includes participants that answered the questions for analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Other: Survey: Multiple survey rounds identifying most important outcomes for effective self-management for non-dialysis CKD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | This was a qualitative part of the survey, in which participants' responses were analysed using conventional content analysis. Participants' responses produced 28 outcomes, each outcome fell into one of 5 themes, which were 'clinical', 'behaviour and self-care', 'healthcare usage', 'psychological and social factors' and 'knowledge, skills & Confidence'. The numbers below shows the frequency of times the outcomes were mentioned in that participant group in qualitative analysis | Posted | Number | items | Between 3 to 6 month |
|
All-cause mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
All-cause mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Other: Survey: Multiple survey rounds identifying most important outcomes for effective self-management for non-dialysis CKD |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naeema Patel | University of Leicester | +44 (0)116 223 6425 | nap20@leicester.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2022 | Jul 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| BG001 | 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. Other: Survey: Multiple survey rounds identifying most important outcomes for effective self-management for non-dialysis CKD |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Cohort 2: Non-Professional Expert | People living with a diagnosis of CKD. This survey focusses on people with non-dialysis CKD, typically stages 3-4. However, this study does 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. This will also include 'significant others' whom are supporters or carers of people with CKD such as a family member or a partner of a person with CKD. Other: Survey: Multiple survey rounds identifying most important outcomes for effective self-management for non-dialysis CKD |
|
|
| Primary | 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. | The participants' mean, median and proportion were calculated on the 9-point Likert scale to establish the consensus criteria. Items /outcomes scoring >70% on 7-9 or mean of 7 or more were retained and taken forward to the following round. 25 out of 28 items were retained and 3 items were taken out as they scored below the consensus criteria | Posted | Mean | Standard Deviation | score on a scale | Between 3 to 6 month |
|
|
|
| Primary | 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 | A ranked weighted score technique was calculated to identify the items that were ranked the most important. The items/outcomes ranked the highest overall were 'prevent or slow the decline of kidney function' and 'feeling more in control of own health and kidney disease'. The data below presents the top 3 ranked outcome overall | Posted | Count of Participants | Participants | No | Between 3 to 6 month |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Cohort 2: Non-Professional Expert | People living with a diagnosis of CKD. This survey focusses on people with non-dialysis CKD, typically stages 3-4. However, this study does 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. This will also include 'significant others' whom are supporters or carers of people with CKD such as a family member or a partner of a person with CKD. Other: Survey: Multiple survey rounds identifying most important outcomes for effective self-management for non-dialysis CKD | 0 | 0 | 0 | 0 | 0 | 0 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Prevent or slow the decline of kidney function |
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| Avoid the need for dialysis or kidney transplant |
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| Care & control of diabetes |
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| Improve life expectancy |
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| Reduce health problems and other complications associated with CKD |
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| Improve troublesome symptoms |
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| Increase physical activity |
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| Improve diet and nutrition |
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| weight management |
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| Adhering to medicines and other treatments |
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| Reduce healthcare service use |
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| Healthcare cost savings |
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| Optimal healthcare service management |
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| Increase patient satisfaction |
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| improve relationship, communication and partnership with the healthcare team |
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| improve depression |
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| Improve feelings of anxiety |
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| Improve emotional well-being |
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| Feeling able to cope better |
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| Improve family and friends understanding and support |
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| improve knowledge and understanding of kidney disease |
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| knowledge and understanding of how to live a healthy lifestyle |
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| Feeling more in control of his own health and kidney disease |
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| increase self-esteem |
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| Feeling more able to solve problems |
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| Improve self-monitoring and health tracking |
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| Improve life expectancy |
|