Chronic Kidney DiseasesNephrocareNCT03708666
Nephrocare mHealth Project: Telemonitoring of Blood Pressure
A study testing Telemonitoring of blood pressure in people with Chronic Kidney Diseases and Blood Pressure, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The Nephrocare mHealth project supports patients with Chronic Kidney Disease with a mobile application and telemonitoring. The application includes the follow-up of blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Blood Pressure
- What is being tested?
- Telemonitoring of blood pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Dutch-speaking
- Signed and approved informed consent
- Follow-up by nephrology at the University Hospitals Leuven or General Hospital Groeninge
Who cannot join
- No Dutch-speaking
- Impaired cognitive condition or medically unstable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nephrocare mHealth: Improvement of Patient Empowerment and Self-management by the Use of Telemonitoring.
The Nephrocare mHealth project supports patients with Chronic Kidney Disease with a mobile application and telemonitoring. The application includes the follow-up of blood pressure.
Read the detailed description
Patients that are included in the Nephrocare mHealth project send their blood pressure results through an app or online website.
The clinical decision support system will alert the patient, as well as the general practitioner and the hospital when the blood pressure is too high or low. In addition the clinical decision support will calculate monthly averages and all the data are connected with the electronic patient files.
- Conditions
- Chronic Kidney Diseases, Blood Pressure
- Being tested
- Telemonitoring of blood pressure
- 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.
Telemonitoring of blood pressureOther
Blood pressure monitoring at least once a week.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring of blood pressure | Other | Patients measure their blood pressure and register their results on the app or website. Receives: Other: Telemonitoring of blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic blood pressure under control
Percentage of patients with blood pressure within target limits
Measured: 6 months
Secondary outcomes (1)
Adaptations of treatment
Percentage of change in hypertension therapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start1 Jun 2017
- Primary completion31 Dec 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- General Hospital Groeninge
- Responsible party
- Principal investigator, Kathleen Claes, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Kathleen Claes, Prof. Dr., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708666
- Sponsor's protocol ID
- S60335
- Other IDs
- AZGS2017056
- Acronym
- Nephrocare
- Status last verified
- Oct 2018
- First submitted
- 13 Oct 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nephrocare mHealth: Improvement of Patient Empowerment and Self-management by the Use of Telemonitoring.
- ClinicalTrials.gov ID
- NCT03708666
- Acronym / sponsor ID
- Nephrocare / S60335
- Conditions
- Chronic Kidney Diseases, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- General Hospital Groeninge
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 17 Oct 2018 (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.
The Nephrocare mHealth project supports patients with Chronic Kidney Disease with a mobile application and telemonitoring. The application includes the follow-up of blood pressure.
Detailed description
Patients that are included in the Nephrocare mHealth project send their blood pressure results through an app or online website.
The clinical decision support system will alert the patient, as well as the general practitioner and the hospital when the blood pressure is too high or low. In addition the clinical decision support will calculate monthly averages and all the data are connected with the electronic patient files.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring of blood pressure | Other | Other: Telemonitoring of blood pressurePatients measure their blood pressure and register their results on the app or website. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dutch-speaking
- Signed and approved informed consent
- Follow-up by nephrology at the University Hospitals Leuven or General Hospital Groeninge
Key exclusion criteria (2 listed)
- No Dutch-speaking
- Impaired cognitive condition or medically unstable
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 |
|---|---|---|
| Telemonitoring of blood pressureBlood pressure monitoring at least once a week. | Other | Telemonitoring of blood pressure |
Primary outcome
Systolic and diastolic blood pressure under control
Time frame: 6 months
Percentage of patients with blood pressure within target limits
1 secondary outcome
Adaptations of treatment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- 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. This study is not recruiting at the moment.
Kathleen Claes, Prof. Dr. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring of blood pressure in people with Chronic Kidney Diseases and Blood Pressure, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 17 Oct 2018. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and diastolic blood pressure under control (time frame: 6 months). 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 17 Oct 2018.