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:
Katholieke Universiteit Leuven
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
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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:
- Are the POC CRP devices technically accurate? Do the measured values agree with CRP values measured at the clinical laboratory?
- 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
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
More Information
Publications:
| Responsible Party: | Jan Verbakel, Research Assistant, Katholieke Universiteit Leuven |
| ClinicalTrials.gov Identifier: | NCT01667172 History of Changes |
| Other Study ID Numbers: | S54271 |
| Study First Received: | August 14, 2012 |
| Last Updated: | August 15, 2012 |
| Health Authority: | Belgium: Ethics Committee |
ClinicalTrials.gov processed this record on June 18, 2013