Technical Accuracy and Userfriendliness of Two Point-of-care C Reactive Protein Devices in Comparison With Laboratory CRP Testing.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jan Verbakel, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01667172
First received: August 14, 2012
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

Study to test technical accuracy and userfriendliness of two Point-of-care C Reactive Protein devices (POC CRP devices) in comparison with laboratory CRP testing on children and adults.

Research questions:

  1. Are the POC CRP devices technically accurate? Do the measured values agree with CRP values measured at the clinical laboratory?
  2. Are the 2 POC CRP devices equivalent ? 2.1. Are the 2 POC CRP devices equally reliable? 2.1.1. Comparison of 2 measurements in the same patient on 1 device (inter-observer-variability) 2.1.2. Comparison of 2 measurements in the same patient on 2 identical devices (inter-device-variability) 2.2. Are the 2 Point-of-Care CRP devices equally userfriendly in a general practice surgery? (userfriendliness

Condition Intervention
Healthy and Acutely Ill Children & Adults
Device: Point-of-Care C Reactive Protein measurement on capillary blood

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Diagnostic
Official Title: Study of Technical Accuracy and Userfriendliness of Two Point-of-care C Reactive Protein Devices

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • technical accuracy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    correlation obtained between the results from the Point-of-care C Reactive Protein devices and the results from the laboratory


Secondary Outcome Measures:
  • User-friendliness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    evaluation of the userfriendliness by General Practitioners at 5 practices, on a five point Likert-scale scoring these criteria: device start-up, test duration, sample size, test characteristics, calibration, measuring range, handling of test tubes, filling of the capillary, placing the test cartridge, test recording and additional material usage. The median results are compared between both devices qualitatively.

  • Inter-device variability [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The inter-device-variability (by 1 physician) was tested on 10 patients in one General Practice surgery each on two different Point-of-Care devices of the same brand.

  • Inter-observer variability [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The inter-observer variability (by two physicians) was tested on 10 patients in one GP surgery on two different Point-of-care devices of the same brand.


Enrollment: 300
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
point-of-care test for CRP Device: Point-of-Care C Reactive Protein measurement on capillary blood
capillary blood fingerstick method to determine C Reactive Protein level in the blood

  Eligibility

Ages Eligible for Study:   1 Month to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children: aged 1 month to 14 years
  • adults: aged 18-65 years

Exclusion Criteria:

  • children and adults not understanding Dutch language
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01667172

Locations
Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Medisch Centrum voor Huisartsen
Leuven, Vlaams-Brabant, Belgium, 3000
Huisartspraktijken
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven