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

February 17, 2015 updated by: Latour Katrien, KU Leuven

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 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Domino vzw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Older (65 years or older) nursing home residents

Exclusion Criteria:

  • Residents not understanding Dutch

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Frank Buntinx, PhD, KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Estimate)

February 18, 2015

Last Update Submitted That Met QC Criteria

February 17, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • CRP-NH0414

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Older Adults

Clinical Trials on Point-of-care test for CRP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe