Multidisciplinary Care for Patients With Chronic Kidney Disease to Increase Their Self-management.

Not Applicable

Completed

• Conditions: Chronic Kidney Diseases
• Interventions: Behavioral: Lifestyle counseling

• Registration Number: NCT03009084
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Through questionnaires with primary care physicians, nephrologists from the University Hospitals of Leuven and patients with chronic kidney disease, the problems will be known.

After the exploration there will be an intervention with patients who meet the in- and exclusion criteria. Around 150-200 patients will be included with a 1:2 randomisation in the control and intervention group. The relevant clinical data and the factors of lifestyle will be questioned at the baseline.

The intervention group will receive individualized therapy by a nurse, for example to quit smoking, to eat healthier and to do more physical activities. This therapy is based on the most important risk factors and will be determined before the start of the therapy. Further on, these patients will also be motivated to take their blood pressure more frequently by using a telemonitoring system.

Study Timeline

• Study First Submitted: 2015-04-11
• Study Start: 2015-09-17
• Study First Submitted QC: 2016-12-30
• Study First Posted: 2017-01-04
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-13
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Lifestyle counseling	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.

Primary Outcome Measures

Name	Time	Method
lipid control	one year	LDL in mmol/l
smoking cessation	one year	percentage of smoking cessation.
blood pressure under control	one year	percentage of patients with blood pressure within target limits
BMI change	one year	BMI change in kg/m²
change in Estimated Glomerular Filtration Rate (eGFR)	one year	Estimated Glomerular Filtration Rate (eGFR) in mL/min/1.73m²

Secondary Outcome Measures

Name	Time	Method
Communication between primary care physicians and the nephrologists.	6 months	Improved communication between primary care physicians and nephrologists measured by a questionnaire.
Relevant clinical data: systolic and diastolic blood pressure	one year	Improved or stable clinical data that are taken at the consultation of nephrology (systolic and diastolic blood pressure).

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium