NCT03009084

Brief Summary

The purpose of this study is to investigate the communication and data sharing between the primary care physician and the nephrologist about patients with chronic kidney disease. Also therapeutic interventions that change behavior and telemonitoring of the blood pressure will be explored and compared to the usual care. The most important aim of this study is to improve the quality of care for the patient with chronic kidney disease in cooperation with the primary care physician and the nephrologist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

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

First Submitted

Initial submission to the registry

April 11, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

September 17, 2015

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

1.5 years

First QC Date

April 11, 2015

Last Update Submit

October 13, 2018

Conditions

Outcome Measures

Primary Outcomes (5)

  • BMI change

    BMI change in kg/m²

    one year

  • smoking cessation

    percentage of smoking cessation.

    one year

  • change in Estimated Glomerular Filtration Rate (eGFR)

    Estimated Glomerular Filtration Rate (eGFR) in mL/min/1.73m²

    one year

  • lipid control

    LDL in mmol/l

    one year

  • blood pressure under control

    percentage of patients with blood pressure within target limits

    one year

Secondary Outcomes (2)

  • Communication between primary care physicians and the nephrologists.

    6 months

  • Relevant clinical data: systolic and diastolic blood pressure

    one year

Study Arms (2)

Intervention group

EXPERIMENTAL

Lifestyle counseling of modifiable risk factors of chronic kidney disease: telemonitoring of blood pressure, counseling for smoking cessation, losing weight and increasing the physical activity.

Behavioral: Lifestyle counseling

Control group

NO INTERVENTION

Usual care.

Interventions

Lifestyle counseling of modifiable risk factors of chronic kidney disease: telemonitoring of blood pressure, counseling for smoking cessation, losing weight and increasing the physical activity.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Predialysis, hemodialysis, peritoneal dialysis, transplantation
  • Included in the care program of chronic kidney diseases
  • Dutch-speaking
  • Signed and approved informed consent

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
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 11, 2015

First Posted

January 4, 2017

Study Start

September 17, 2015

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations