Chronic Kidney DiseaseINCLUDE-CKDNCT07613593
INCLUDE-CKD: INCLUsive Digital carE for Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Non-Interventional Study
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jun 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
- 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.
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- 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:
- 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.
- 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:
- 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.
- 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:
- Employed by PHU or working in direct partnership with the Wessex Kidney Centre.
- Directly involved in the care of patients with chronic kidney disease and/or in the implementation or support of MyRenalCare.
- Able and willing to provide informed consent for a recorded interview.
- Able to reflect on experiences and observations relevant to the delivery, uptake, or equity implications of digital health in CKD.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Portsmouth Hospitals University NHS Trust
Portsmouth, Hampshire, PO6 3LY
Sam Newman, 02392286000 ext. 5153, sam.newman6@hs.net
sam.newman6@nhs.net
About this study
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
- Being tested
- Non-Interventional Study
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called non-interventional
Study is non-interventional.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12-months
Secondary outcomes (6)
Secondary
Outcome measure1: Number of unplanned and planned hospital admissions for MyRenalCare users compared with matched usual-care controls.
Measured: 12-months
Secondary
Outcome measure 2: Number of outpatient visits (renal and non-renal) for MyRenalCare users compared with matched usual-care controls.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start12 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Ardia Digital Health Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613593
- Sponsor's protocol ID
- PHU/2024/28
- Other IDs
- NIHR510403
- Acronym
- INCLUDE-CKD
- Status last verified
- Jul 2026
- First submitted
- 7 May 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INCLUDE-CKD: INCLUsive Digital carE for Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07613593
- Acronym / sponsor ID
- INCLUDE-CKD / PHU/2024/28
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- Ardia Digital Health Ltd
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Existing MyRenalCare users (retrospective cohort) | – | Other: Non-Interventional StudyAdults 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. |
| New MyRenalCare users (prospective cohort) | – | Other: Non-Interventional StudyAdults 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. |
| Matched usual care controls | – | Other: Non-Interventional StudyAdults 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. |
| Patients and staff participating in qualitative interviews (qualitative cohort) | – | Other: Non-Interventional StudyA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (26 listed)
- 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:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyAlso: non-interventionalStudy is non-interventional. | Other | Existing MyRenalCare users (retrospective cohort), Matched usual care controls, New MyRenalCare users (prospective cohort), Patients and staff participating in qualitative interviews (qualitative cohort) |
Primary outcome
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.
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.
6 secondary outcomes
Secondary
Time frame: 12-months
Secondary
Time frame: 12-months
Secondary
Time frame: 12-months
Secondary
Time frame: 12-months
Secondary
Time frame: 12-months
Secondary
Time frame: 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sam Newman (+442392286000 ext. 5153, sam.newman6@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.