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Nephrocare mHealth Project: Telemonitoring of Blood Pressure (Nephrocare)

Primary Purpose

Chronic Kidney Diseases, Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Telemonitoring of blood pressure
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Leuven

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Telemonitoring of blood pressure

Arm Description

Patients measure their blood pressure and register their results on the app or website.

Outcomes

Primary Outcome Measures

Systolic and diastolic blood pressure under control
Percentage of patients with blood pressure within target limits

Secondary Outcome Measures

Adaptations of treatment
Percentage of change in hypertension therapy

Full Information

First Posted
October 13, 2018
Last Updated
October 13, 2018
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
General Hospital Groeninge
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1. Study Identification

Unique Protocol Identification Number
NCT03708666
Brief Title
Nephrocare mHealth Project: Telemonitoring of Blood Pressure
Acronym
Nephrocare
Official Title
Nephrocare mHealth: Improvement of Patient Empowerment and Self-management by the Use of Telemonitoring.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
General Hospital Groeninge

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Blood Pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemonitoring of blood pressure
Arm Type
Other
Arm Description
Patients measure their blood pressure and register their results on the app or website.
Intervention Type
Other
Intervention Name(s)
Telemonitoring of blood pressure
Intervention Description
Blood pressure monitoring at least once a week.
Primary Outcome Measure Information:
Title
Systolic and diastolic blood pressure under control
Description
Percentage of patients with blood pressure within target limits
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adaptations of treatment
Description
Percentage of change in hypertension therapy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Claes, Prof. Dr.
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Nephrocare mHealth Project: Telemonitoring of Blood Pressure

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