INCLUDE-CKD: INCLUsive Digital carE for Chronic Kidney Disease

Ki vehet részt

• 5.1.1 Inclusion criteria - MyRenalCare users (retrospective and prospective cohorts)
• Adults will be eligible for inclusion in the MyRenalCare cohorts if they meet all of the following:
• Aged 18 years or over
• Under the care of the Wessex Kidney Centre
• Registered with, or offered and subsequently enrolled onto, the MyRenalCare platform during the defined retrospective or prospective periods
• Able to understand study information and, where applicable, provide informed consent for use of their data for research purposes; Specific CKD stage definitions and thresholds (e.g. based on eGFR, albuminuria or uPCR) will be documented in the study manual to ensure consistent application; 5.1.2 Inclusion criteria - matched usual care controls; Adults will be eligible for inclusion in the matched control cohorts if they meet all of the following:
• Aged 18 years or over
• Under the care of the Wessex Kidney Centre for chronic kidney disease
• Not registered with or using MyRenalCare at any point during the relevant observation period
• Have sufficient clinical and administrative data available in the renal electronic patient record to enable matching and outcome assessment; Controls will be identified retrospectively from the renal electronic patient record and matched to MyRenalCare users using a predefined matching strategy; 5.1.3 Inclusion criteria - qualitative interview participants (patients and staff); Patients will be eligible to take part in the qualitative interview component if they meet all of the following:
• Aged 18 years or over
• Currently using, or recently offered, the MyRenalCare platform as part of their CKD care at the Wessex Kidney Centre
• Able to understand spoken and written English to the extent required for participation in an interview
• Able and willing to provide written informed consent for participation in a recorded interview
• Belong to a demographic or clinical subgroup of interest for the study (e.g. varying age, ethnicity, CKD stage, or digital engagement level), as part of purposive sampling to support diversity and equity analysis; Clinical staff will be eligible if they meet all of the following:
• Employed by PHU or working in direct partnership with the Wessex Kidney Centre
• Directly involved in the care of patients with chronic kidney disease and/or in the implementation or support of MyRenalCare
• Able and willing to provide informed consent for a recorded interview
• Able to reflect on experiences and observations relevant to the delivery, uptake, or equity implications of digital health in CKD

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• Patients who have previously indicated that they do not wish their routinely collected clinical data to be used for research where such opt-out applies to this study
• Staff members currently on extended leave or unable to participate during the data collection period
• Patients with acute kidney injury without established chronic kidney disease
• Clinical staff who are not directly involved in the care of patients with chronic kidney disease or in the implementation of the MyRenalCare platform
• Patients with a very limited life expectancy where participation in routine digital monitoring is not appropriate, as judged by the clinical team
• Patients who are unable to be identified reliably in the available data sources (for example, inconsistent or missing key identifiers)
• Any other situation where, in the opinion of the responsible clinician, participation in the study processes (including data use) would be inappropriate or unduly burdensome
• Individuals who do not wish to have their views included in recorded interview transcripts or are unable to provide informed consent for participation
• Any situation where, in the opinion of the study team or the individual's manager, participation would be inappropriate or burdensome due to role, availability, or conflict of interest