INCLUDE-CKD: INCLUsive Digital carE for Chronic Kidney Disease

Korábbi kezelés

• 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.

Más betegség

• 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.

Egyéb

• 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.

• 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.