Clinical trial NCT03009084: Multidisciplinary Care for Patients With Chronic Kidney Disease to Increase Their Self-management.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: BMI change
timeFrame: one year
measure: smoking cessation
timeFrame: one year
measure: change in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: one year
measure: lipid control
timeFrame: one year
measure: blood pressure under control
timeFrame: one year
Secondary outcomes:
measure: Communication between primary care physicians and the nephrologists.
timeFrame: 6 months
measure: Relevant clinical data: systolic and diastolic blood pressure
timeFrame: one year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Kathleen Claes, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: