Nephrocare mHealth Project: Telemonitoring of Blood Pressure (Nephrocare)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Blood Pressure
• Intervention / Treatment: Other: Telemonitoring 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 Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Dutch-speaking
• Signed and approved informed consent
• Follow-up by nephrology at the University Hospitals Leuven or General Hospital Groeninge

Exclusion Criteria:

• No Dutch-speaking
• Impaired cognitive condition or medically unstable

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Telemonitoring of blood pressure; Patients measure their blood pressure and register their results on the app or website.	Other: Telemonitoring of blood pressure; Blood pressure monitoring at least once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic and diastolic blood pressure under control	Percentage of patients with blood pressure within target limits	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adaptations of treatment	Percentage of change in hypertension therapy	6 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: General Hospital Groeninge
• Investigators: Principal Investigator: Kathleen Claes, Prof. Dr., Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: October 13, 2018
• First Submitted That Met QC Criteria: October 13, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 13, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: S60335; AZGS2017056 (Other Identifier: AZ Groeninge)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No