INCLUDE-CKD: INCLUsive Digital carE for Chronic Kidney Disease

NCT07613593 | Not Yet Recruiting DMC

• 2 other identifiers: PHU/2024/28NIHR510403
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will provide valuable insights into the demographics of MyRenalCare users, their digital adherence, and the overall impact of the app on health outcomes, healthcare costs, and environmental sustainability.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• Primary

  Outcome measure 1: Number and proportion of MyRenalCare users by age, sex, ethnicity and Index of Multiple Deprivation quintile, compared with the CKD population under Wessex Kidney Centre care. Prevalence ratios will also be calculated.

  12 months

• Primary

  Outcome measure 2: Composite digital adherence score (0-100) for MyRenalCare users, combining log-in frequency, completeness of blood pressure and symptom entries, use of secure messaging and duration of sustained use. Analyses stratified by age, sex, ethnicity and deprivation.

  12-months

Secondary Outcomes (6)

• Secondary

  12-months

• Secondary

  12-months

• Secondary

  12-months

• Secondary

  12-months

• Secondary

  12-months

Study Arms (4)

Existing MyRenalCare users (retrospective cohort)

Adults who were already registered and actively using MyRenalCare at the start of the retrospective observation period. Data will be collected retrospectively from their routine use of the platform.

Other: Non-Interventional Study

New MyRenalCare users (prospective cohort)

Adults who are newly offered and enroll onto MyRenalCare during the defined recruitment window. Participants will use the platform as part of routine care, and their engagement will be prospectively monitored.

Other: Non-Interventional Study

Matched usual care controls

Adults with CKD receiving standard care at the Wessex Kidney Centre who are not enrolled onto MyRenalCare. These participants receive usual clinical care without access to the MyRenalCare platform.

Other: Non-Interventional Study

Patients and staff participating in qualitative interviews (qualitative cohort)

A subset of MyRenalCare users (both retrospective and prospective) and clinical staff involved in their care who are invited to take part in interviews about their experiences with MyRenalCare.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Study is non-interventional.

Also known as: non-interventional

Existing MyRenalCare users (retrospective cohort); Matched usual care controls; New MyRenalCare users (prospective cohort); Patients and staff participating in qualitative interviews (qualitative cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Retrospective: \~450-500 existing users + matched controls(24 months data). * Comparison with entire WKC CKD population * Prospective: \~500-550 new users + matched controls (6 months). * Exploratory: \~500 dialysis or pre transplant MyRenalCare users (no matched controls). * Qualitative: 15-25 patients + 10-15 staff.

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• Patients with acute kidney injury without established chronic kidney disease.
• Patients with a very limited life expectancy where participation in routine digital monitoring is not appropriate, as judged by the clinical team.
• 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.
• 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.
• Clinical staff who are not directly involved in the care of patients with chronic kidney disease or in the implementation of the MyRenalCare platform.
• Staff members currently on extended leave or unable to participate during the data collection period.
• 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.

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead
• Ardia Digital Health Ltd: collaborator

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 29, 2026
• Study Start: May 19, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share