- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05215483
Availability and Advice on Test Uptake During the COVID-19 Pandemic: a Vignette Study.
Availability and Advice on Test Uptake During the COVID-19 Pandemic: a Vignette Study on Lateral Flow Testing Policy in the Netherlands.
Study Overview
Status
Conditions
Detailed Description
In an online randomised multi-factorial survey (vignette study) participants are randomised to assess four scenario's. Between subject testing advise is randomised (IV1; 2 levels) and the availability of LFT (IV2; 2 levels). Within subject we asked participants to assess their most likely behaviour on day 1 of symptoms and day 3 of unchanged symptoms (IV3; 2 levels). Corona-related symptoms are randomly presented (IV4; 4 levels) and new incidences of symptoms are presented in additional vignettes describing new months (IV5; 4 levels).
Subjects are asked to immerse themselves in the scenario's before answering what their most likely behaviour would be: a) go to a test facility b) use a LFT c) wait and see or 4) no test. Participants who didn't choose the test facility on day 1 were presented with the same vignette on day 3 with unchanged symptoms, and were asked their most likely behaviour again.
After assessing the scenario's, participants fill in a questionnaire assessing demographics, behavioural determinants related to test behaviour, vaccine status, current symptoms and previous experience with Corona and testing.
The primary outcomes is defined as the average strategy sensitivity over time and therefore the chance of detecting a Covid-infection. Average strategy sensitivity is calculated by converting the choice of testing behaviour into the corresponding sensitivity score (PCR =1, LFT day 1 = .8, LFT day 3 = .7, wait and see and no test = 0), averaged over four scenario's.
Our primary hypothesis is:
Adjusting the governmental testing advice will lead to a higher strategy sensitivity.
In follow-up analysis we will explore the following hypothesis:
- Availability of LFT at home will lead to a higher strategy sensitivity.
- The type of corona related symptoms (mild or severe) are predictive of the type of test used.
- When confronted with a new incidence of corona-related symptoms over time, strategy sensitivity will decline.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Utrecht
-
Bilthoven, Utrecht, Netherlands, 3720 BA
- National Institute for Public Health and the Environment
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Participants were recruited from an online research panel representative for the Dutch population.
Inclusion Criteria:
- non
Exclusion Criteria:
- non
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Customised advice + LFT available at home
Respondents will see an altered testing advice in text and picture in which they are allowed to use LFT with corona related symptoms. Respondents will informed in writing that they don't currently have any LFT available at home. |
Customised advice: With Corona related symptoms, get tested at a test facility.
If this isn't possible, use a Lateral Flow test.
LFT availability: Enough lateral flow tests available at home
|
|
Experimental: Customised advice + No LFT available at home
Respondents will see an altered testing advice in text and picture in which they are allowed to use LFT with corona related symptoms. Respondents will informed in writing that they don't currently have any LFT available at home. |
Customised advice: With Corona related symptoms, get tested at a test facility.
If this isn't possible, use a Lateral Flow test.
LFT availability: No lateral flow tests available at home
|
|
Experimental: Regular advice + LFT available at home
Respondents will see the regular testing advice in text and picture with the current governmental advice to visit a test facility with corona related symptoms. Respondents will informed in writing that they don't currently have any LFT available at home. |
LFT availability: Enough lateral flow tests available at home
Government guideline testing advice: "With Corona related symptoms, get tested at a test facility".
|
|
Active Comparator: Regular advice + No LFT available at home
Respondents will see the regular testing advice in text and picture with the current governmental advice to visit a test facility with corona related symptoms. Respondents will informed in writing that they don't currently have any LFT available at home. |
LFT availability: No lateral flow tests available at home
Government guideline testing advice: "With Corona related symptoms, get tested at a test facility".
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average strategy sensitivity over time: day 1
Time Frame: average strategy sensitivity day 1
|
The sensitivity of the test chosen was used to convert each answer: test facility on day 1 = 1, LFT on day 1= 0.8, Wait and see or No test = 0. Sensitivity scores were then averaged over the four scenario's.
|
average strategy sensitivity day 1
|
|
Maximum average strategy sensitivity over time
Time Frame: maximum average strategy sensitivity day 1 and 3
|
The sensitivity of the test chosen was used to convert each answer: test facility on day 1 or day 3 = 1, LFT on day 1= 0.8, LFT on day 3= 0.7, Wait and see or No test = 0. Sensitivity scores were then averaged over the four scenario's.
The highest score of day 1 and day 3 was used to calculate the maximum sensitivity score.
|
maximum average strategy sensitivity day 1 and 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Willingness to test day 1
Time Frame: Day 1
|
Willingness to test on day 1 (LFT & PCR =1, no test = 0), averaged over the four scenario's.
|
Day 1
|
|
Willingness to test - maximum
Time Frame: Day 1 and 3
|
Willingness to test on day 1 and 3 (LFT & PCR =1, no test = 0), averaged over the four scenario's.
|
Day 1 and 3
|
|
Type of test chosen day 1
Time Frame: Day 1
|
Percentage of testing behaviour (test facility, LFT, Wait and see, No test) on day 1, averaged over the four scenario's.
|
Day 1
|
|
Type of test chosen day 3
Time Frame: Day 3
|
Percentage of testing behaviour (test facility, LFT, Wait and see, No test) on day 3, averaged over the four scenario's.
|
Day 3
|
Collaborators and Investigators
Investigators
- Study Chair: Marijn de Bruin, prof, RIVM
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G&M-537
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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