INCLUDE-CKD: INCLUsive Digital carE for Chronic Kidney Disease (INCLUDE-CKD)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Other: Non-Interventional Study

• Study Type: Observational
• Enrollment (Estimated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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:

1. Aged 18 years or over.
2. Under the care of the Wessex Kidney Centre
3. Registered with, or offered and subsequently enrolled onto, the MyRenalCare platform during the defined retrospective or prospective periods.
4. 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:

1. Aged 18 years or over.
2. Under the care of the Wessex Kidney Centre for chronic kidney disease.
3. Not registered with or using MyRenalCare at any point during the relevant observation period.
4. 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:

1. Aged 18 years or over.
2. Currently using, or recently offered, the MyRenalCare platform as part of their CKD care at the Wessex Kidney Centre.
3. Able to understand spoken and written English to the extent required for participation in an interview.
4. Able and willing to provide written informed consent for participation in a recorded interview.
5. 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:

1. Employed by PHU or working in direct partnership with the Wessex Kidney Centre.
2. Directly involved in the care of patients with chronic kidney disease and/or in the implementation or support of MyRenalCare.
3. Able and willing to provide informed consent for a recorded interview.
4. Able to reflect on experiences and observations relevant to the delivery, uptake, or equity implications of digital health in CKD.

Exclusion Criteria:

1. Patients with acute kidney injury without established chronic kidney disease.
2. Patients with a very limited life expectancy where participation in routine digital monitoring is not appropriate, as judged by the clinical team.
3. 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.
4. Patients who are unable to be identified reliably in the available data sources (for example, inconsistent or missing key identifiers).
5. 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.
6. Clinical staff who are not directly involved in the care of patients with chronic kidney disease or in the implementation of the MyRenalCare platform.
7. Staff members currently on extended leave or unable to participate during the data collection period.
8. Individuals who do not wish to have their views included in recorded interview transcripts or are unable to provide informed consent for participation.
9. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Study is non-interventional.; Other Names: non-interventional
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; Study is non-interventional.; Other Names: non-interventional
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; Study is non-interventional.; Other Names: non-interventional
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; Study is non-interventional.; Other Names: non-interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary	Outcome measure1: Number of unplanned and planned hospital admissions for MyRenalCare users compared with matched usual-care controls.	12-months
Secondary	Outcome measure 2: Number of outpatient visits (renal and non-renal) for MyRenalCare users compared with matched usual-care controls.	12-months
Secondary	Outcome measure 3: CKD progression, measured by change in eGFR, movement between CKD stages, and initiation of kidney replacement therapy for MyRenalCare users versus matched controls.	12-months
Secondary	Outcome measure 4: NHS healthcare costs per patient-year for MyRenalCare users compared with matched usual-care controls, including inpatient, outpatient, emergency and relevant community or virtual care contacts.	12-months
Secondary	Outcome measure 5: Estimated patient travel-related CO₂ emissions for renal care appointments for MyRenalCare users versus matched usual-care controls, based on travel distance and mode.	12-months
Secondary	Outcome measure 6: Themes from qualitative interviews with patients and staff on MyRenalCare usability, support needs, barriers and facilitators to digital engagement.	12-months

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust
• Collaborators: Ardia Digital Health Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): May 19, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: PHU/2024/28; NIHR510403 (Other Identifier: NIHR - 2025/400 i4i FAST Commissioned)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO