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

May 21, 2026 updated by: Portsmouth Hospitals NHS Trust
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary
Time Frame: 12 months
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
Time Frame: 12-months

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary
Time Frame: 12-months
Outcome measure1: Number of unplanned and planned hospital admissions for MyRenalCare users compared with matched usual-care controls.
12-months
Secondary
Time Frame: 12-months
Outcome measure 2: Number of outpatient visits (renal and non-renal) for MyRenalCare users compared with matched usual-care controls.
12-months
Secondary
Time Frame: 12-months
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
Time Frame: 12-months
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
Time Frame: 12-months
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
Time Frame: 12-months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Portsmouth Hospitals NHS Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ardia Digital Health Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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