Health TrialsbyHealthPanel

INCLUDE-CKD: INCLUsive Digital carE for Chronic Kidney Disease

ConditionChronic Kidney Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPortsmouth Hospitals NHS Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • Non-Interventional Study

    Other intervention

    Study is non-interventional.

Treatment groups

1,000 Participants
are divided into 4 treatment groups
Group A: Existing MyRenalCare users (retrospective cohort)1 intervention
Group B: New MyRenalCare users (prospective cohort)1 intervention
Group C: Matched usual care controls1 intervention
Group D: Patients and staff participating in qualitative interviews (qualitative cohort)1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12-months

Secondary outcomes

1

Secondary

Outcome measure1: Number of unplanned and planned hospital admissions for MyRenalCare users compared with matched usual-care controls.

Time frame
12-months
2

Secondary

Outcome measure 2: Number of outpatient visits (renal and non-renal) for MyRenalCare users compared with matched usual-care controls.

Time frame
12-months
3

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.

Time frame
12-months
4

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.

Time frame
12-months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Portsmouth Hospitals NHS Trust

Lead sponsor

Ardia Digital Health Ltd

Collaborator

Source ClinicalTrials.gov
Apply now