Multidisciplinary Care for Patients With Chronic Kidney Disease to Increase Their Self-management.
Primary Purpose
Chronic Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Lifestyle counseling
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Kidney Diseases
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
Sites / Locations
- University Hospitals Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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.
Usual care.
Outcomes
Primary Outcome Measures
BMI change
BMI change in kg/m²
smoking cessation
percentage of smoking cessation.
change in Estimated Glomerular Filtration Rate (eGFR)
Estimated Glomerular Filtration Rate (eGFR) in mL/min/1.73m²
lipid control
LDL in mmol/l
blood pressure under control
percentage of patients with blood pressure within target limits
Secondary Outcome Measures
Communication between primary care physicians and the nephrologists.
Improved communication between primary care physicians and nephrologists measured by a questionnaire.
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).
Full Information
NCT ID
NCT03009084
First Posted
April 11, 2015
Last Updated
October 13, 2018
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT03009084
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 17, 2015 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Intervention Description
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 Measure Information:
Title
BMI change
Description
BMI change in kg/m²
Time Frame
one year
Title
smoking cessation
Description
percentage of smoking cessation.
Time Frame
one year
Title
change in Estimated Glomerular Filtration Rate (eGFR)
Description
Estimated Glomerular Filtration Rate (eGFR) in mL/min/1.73m²
Time Frame
one year
Title
lipid control
Description
LDL in mmol/l
Time Frame
one year
Title
blood pressure under control
Description
percentage of patients with blood pressure within target limits
Time Frame
one year
Secondary Outcome Measure Information:
Title
Communication between primary care physicians and the nephrologists.
Description
Improved communication between primary care physicians and nephrologists measured by a questionnaire.
Time Frame
6 months
Title
Relevant clinical data: systolic and diastolic blood pressure
Description
Improved or stable clinical data that are taken at the consultation of nephrology (systolic and diastolic blood pressure).
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Claes, Prof. Dr.
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Multidisciplinary Care for Patients With Chronic Kidney Disease to Increase Their Self-management.
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