Trial document





This trial has been registered retrospectively.
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  DRKS00009812

Trial Description

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Title

REnal Function in Ambulatory CarE

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Trial Acronym

REFACE

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URL of the Trial

http://www.kfh-stiftung-praeventivmedizin.de/content/view/download/abstract_reface.pdf

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Brief Summary in Lay Language

The REFACE study will explore how general practitioners and family doctors care for patients with chronically decreased kidney function, who are not on dialysis. The study will also examine how family doctors and nephrologists work together.

Decreased kidney function (chronic kidney disease, CKD) is common. In about 1 in 10 people over 18, kidney function is reduced. Hypertension and diabetes are the main risk factors. Because the function of the kidney diminishes with age, the proportion of elderly people with decreased renal function CKD is high. CKD does not have any particular symptoms unless the kidney function is very low.

The study aims to examine how the kidney function of patients is documented and monitored by family doctors and how family doctors cooperate with kidney specialists (nephrologists).

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Brief Summary in Scientific Language

The course of CKD is usually asymptomatic untill the late stages. The prevalence of CKD increases with age to 30-50% in the oldest age groups. Only a small fraction (<0.5%) of patients will require renal replacement therapy. Major causes of end stage renal failure are diabetes and hypertension, which opens the possibility of preventing end stage renal disease by optimal treatment of these causes. A large proportion of patients with chronic renal failure are managed by family physicians.

In the context of the population-based cohort study SHIP (Study of Health in Pomerania) ca. 4,000 patient data sets are studied, with extensive health data. Data from the data set will be combined with accounting data of the German statutory Health Insurance (data of the Kassenärztliche Vereinigung) over the years 2002 to 2013. Approximately 10% of the SHIP population has renal dysfunction. The existing data allow for this longitudinal study to describe and evaluate the course of renal impairment and the quality of ambulatory care of patients with chronic renal failure.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00009812
  •   2016/04/05
  •   [---]*
  •   yes
  •   Approved
  •   BB39/08, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N18 -  Chronic kidney disease
  •   N19 -  Unspecified kidney failure
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Interventions/Observational Groups

  •   Observational study, using data from the SHIP-2 cohort study in combination with secondary data, coding and monitoring of chronic kidney disease by ambulatory care practitioners is evaluated
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Percentage of CKD patients who are coded as having CKD in secondary data.

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Secondary Outcome

Percentage of CKD patients in different stages of CKD, who are coded as having CKD.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2015/04/01
  •   [---]*
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   90   Years
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Additional Inclusion Criteria

The original cohort study (SHIP-2) included a two-stage stratified cluster sample of adults aged 20–79 years drawn from the population of western Pomerania.
Our study is based on a follow-up of this cohort, approximately 11 years later.
The sample is population-based.

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Exclusion Criteria

-

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Addresses

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    • KFH Kuratorium für Dialyse und Nierentransplantation e.V. (KFH)
    • Martin-Behaim-Straße 20
    • 63263  Neu-Isenburg
    • Germany
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    • Abteilung Allgemeinmedizin, Institut für Community Medicine, Universitätsmedizin Greifswald
    • Mr.  Prof. Dr.  Jean-François Chenot  Wirkner 
    • Fleischmannstraße 6
    • 18055  Greifswald
    • Germany
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    • [---]*
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    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

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    • KFH Kuratorium für Dialyse und Nierentransplantation e.V. (KFH)
    • Martin-Behaim-Straße 20
    • 63263  Neu-Isenburg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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