NCT03708666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

October 13, 2018

Last Update Submit

October 13, 2018

Conditions

Chronic Kidney DiseasesBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • Systolic and diastolic blood pressure under control

    Percentage of patients with blood pressure within target limits

    6 months

Secondary Outcomes (1)

  • Adaptations of treatment

    6 months

Study Arms (1)

Telemonitoring of blood pressure

OTHER

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

Other: Telemonitoring of blood pressure

Interventions

Telemonitoring of blood pressureOTHER

Blood pressure monitoring at least once a week.

Telemonitoring of blood pressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kathleen Claes, Prof. Dr.

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. K. Claes

Study Record Dates

First Submitted

October 13, 2018

First Posted

October 17, 2018

Study Start

June 1, 2017

Primary Completion

December 31, 2017

Study Completion

June 30, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)