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Technical Accuracy and Userfriendliness of a Point-Of-Care C Reactive Protein Device in a Nursing Home Setting

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ClinicalTrials.gov Identifier: NCT02104999
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
Latour Katrien, KU Leuven

Brief Summary:
Study to test the technical accuracy and userfriendliness of a Point-of-care C Reactive Protein device (POC CRP device) in comparison with laboratory CRP testing in nursing home residents

Condition or disease Intervention/treatment Phase
Healthy Older Adults Ill Older Adults Device: Point-of-care test for CRP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Technical Accuracy and Userfriendliness of a Point-Of-Care C Reactive Protein (CRP) Device in Comparison With Laboratory CRP Testing in Nursing Home Residents.
Study Start Date : June 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

Arm Intervention/treatment
Point-of-care test for CRP
Device: C Reactive Protein (CRP) measurement on capillary blood using a point-of-care test to determine the CRP level in the blood
Device: Point-of-care test for CRP
Device: C Reactive Protein (CRP) measurement on capillary blood using a point-of-care test to determine the CRP level in the blood




Primary Outcome Measures :
  1. Technical accuracy [ Time Frame: 2 month ]
    Correlation between the results of the Point-of-care C Reactive Protein device and the results of the laboratory


Secondary Outcome Measures :
  1. User-friendliness [ Time Frame: 2 months ]
    Evaluation of the user-friendliness on a five point Likert-scale. Following items are scored: 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Older (65 years or older) nursing home residents

Exclusion Criteria:

  • Residents not understanding Dutch

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104999


Locations
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Belgium
Domino vzw
Gent, Oost-Vlaanderen, Belgium, 9000
Sponsors and Collaborators
KU Leuven
Investigators
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Principal Investigator: Frank Buntinx, PhD KU Leuven

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Responsible Party: Latour Katrien, Research Assistant, KU Leuven
ClinicalTrials.gov Identifier: NCT02104999     History of Changes
Other Study ID Numbers: CRP-NH0414
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015