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| ID | Type | Description | Link |
|---|---|---|---|
| NIHR510403 | Other Identifier | NIHR - 2025/400 i4i FAST Commissioned |
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| Name | Class |
|---|---|
| Ardia Digital Health Ltd | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Study is non-interventional. |
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| 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 |
| 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. |
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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:
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:
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:
Clinical staff will be eligible if they meet all of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sam Newman | Contact | +442392286000 | 5153 | sam.newman6@nhs.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portsmouth Hospitals University NHS Trust | Recruiting | Portsmouth | Hampshire | PO6 3LY | United Kingdom |
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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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| 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 |
| 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 |