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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nephrocare: Multidisciplinary Care for Patients With Chronic Kidney Disease: an Increase of Patient Empowerment and Self-management by Using Interactive and Communication Tools and Nursing Interventions.

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Behavioral: Lifestyle counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>Usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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