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

Chronic Kidney Diseases Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009084
• Other study ID #: S57777
• Status: Completed
• Phase: N/A
• Start date: September 17, 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: October 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI change	BMI change in kg/m²	one year
Primary	smoking cessation	percentage of smoking cessation.	one year
Primary	change in Estimated Glomerular Filtration Rate (eGFR)	Estimated Glomerular Filtration Rate (eGFR) in mL/min/1.73m²	one year
Primary	lipid control	LDL in mmol/l	one year
Primary	blood pressure under control	percentage of patients with blood pressure within target limits	one year
Secondary	Communication between primary care physicians and the nephrologists.	Improved communication between primary care physicians and nephrologists measured by a questionnaire.	6 months
Secondary	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