Nephrocare mHealth Project: Telemonitoring of Blood Pressure | NCT03708666

Studies
Nephrocare mHealth Project: Telemonitoring of Blood Pressure

NCT03708666

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Oct 17, 2018Actual

Enrollment

79Actual

Phase

Not Applicable

Conditions

Chronic Kidney Diseases
Blood Pressure

Interventions

Telemonitoring of blood pressure

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
AZGS2017056	Other Identifier	AZ Groeninge

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Jun 30, 2018Actual

First Submitted Date

Oct 13, 2018

First Submission Date that Met QC Criteria

Oct 13, 2018

First Posted Date

Oct 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2018

Last Update Posted Date

Oct 17, 2018Actual

Name	Class
General Hospital Groeninge	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

79Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Telemonitoring of blood pressure	Other	Blood pressure monitoring at least once a week.	Telemonitoring of blood pressure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kathleen Claes, Prof. Dr.	Universitaire Ziekenhuizen KU Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Leuven		Leuven		3000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided