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

Healthy Older Adults Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104999
• Other study ID #: CRP-NH0414
• Status: Completed
• Phase: N/A
• First received: April 2, 2014
• Last updated: February 17, 2015
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Older (65 years or older) nursing home residents

Exclusion Criteria:

• Residents not understanding Dutch

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Older Adults
• Ill Older Adults

Intervention

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

Locations

Country	Name	City	State
Belgium	Domino vzw	Gent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical accuracy	Correlation between the results of the Point-of-care C Reactive Protein device and the results of the laboratory	2 month	No
Secondary	User-friendliness	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	No