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Completed

NCT Number: NCT03009084

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

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Counseling

Behavioral

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 outcomes

  1. BMI change

    Time frame: one year

    BMI change in kg/m²

  2. smoking cessation

    Time frame: one year

    percentage of smoking cessation.

  3. change in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: one year

    Estimated Glomerular Filtration Rate (eGFR) in mL/min/1.73m²

  4. lipid control

    Time frame: one year

    LDL in mmol/l

  5. blood pressure under control

    Time frame: one year

    percentage of patients with blood pressure within target limits

Secondary outcomes

  1. Communication between primary care physicians and the nephrologists.

    Time frame: 6 months

    Improved communication between primary care physicians and nephrologists measured by a questionnaire.

  2. Relevant clinical data: systolic and diastolic blood pressure

    Time frame: one year

    Improved or stable clinical data that are taken at the consultation of nephrology (systolic and diastolic blood pressure).

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 4, 2017
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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