Healthy Older AdultsNCT02104999
Technical Accuracy and Userfriendliness of a Point-Of-Care C Reactive Protein Device in a Nursing Home Setting
A study testing Point-of-care test for CRP in people with Healthy Older Adults and Ill Older Adults, run by KU Leuven at 1 site in Belgium.
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 Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Older Adults, Ill Older Adults
- What is being tested?
- Point-of-care test for CRP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older (65 years or older) nursing home residents
Who cannot join
- Residents not understanding Dutch
Trial locations and contacts
1 site in 1 country.
About this study
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 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
- Conditions
- Healthy Older Adults, Ill Older Adults
- Being tested
- Point-of-care test for CRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care test for CRPDevice
Device: C Reactive Protein (CRP) measurement on capillary blood using a point-of-care test to determine the CRP level in the blood
| Study group | Role | What they receive |
|---|---|---|
| Point-of-care test for CRP | Other | Device: C Reactive Protein (CRP) measurement on capillary blood using a point-of-care test to determine the CRP level in the blood Receives: Device: Point-of-care test for CRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical accuracy
Correlation between the results of the Point-of-care C Reactive Protein device and the results of the laboratory
Measured: 2 month
Secondary outcomes (1)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Older AdultsStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Latour Katrien, KU Leuven
- Investigators
- Frank Buntinx, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104999
- Sponsor's protocol ID
- CRP-NH0414
- Status last verified
- Feb 2015
- First submitted
- 2 Apr 2014
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02104999
- Acronym / sponsor ID
- CRP-NH0414
- Conditions
- Healthy Older Adults, Ill Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Point-of-care test for CRP | Other | Device: Point-of-care test for CRPDevice: C Reactive Protein (CRP) measurement on capillary blood using a point-of-care test to determine the CRP level in the blood |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Older (65 years or older) nursing home residents
Key exclusion criteria (1 listed)
- Residents not understanding Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care test for CRPDevice: 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 |
Primary outcome
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
1 secondary outcome
User-friendliness
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Buntinx, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care test for CRP in people with Healthy Older Adults and Ill Older Adults, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical accuracy (time frame: 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.