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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05215483
Other study ID # G&M-537
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2021
Est. completion date November 16, 2021

Study information

Verified date January 2022
Source National Institute for Public Health and the Environment (RIVM)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Lateral Flow Testing (LFT) use for COVID-19 related symptoms continues to rise, despite governmental advice to test at a test facility. In this study we investigate whether 1) adjusting the governmental testing advice will lead to a collective increase of people who test with COVID-19 symptoms and if this leads to a higher strategy sensitivity.


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: 1. Adjusting the governmental testing advice will lead to a higher strategy sensitivity. In follow-up analysis we will explore the following hypothesis: 2. Availability of LFT at home will lead to a higher strategy sensitivity. 3. The type of corona related symptoms (mild or severe) are predictive of the type of test used. 4. When confronted with a new incidence of corona-related symptoms over time, strategy sensitivity will decline.


Recruitment information / eligibility

Status Completed
Enrollment 3270
Est. completion date November 16, 2021
Est. primary completion date November 16, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Participants were recruited from an online research panel representative for the Dutch population. Inclusion Criteria: - non Exclusion Criteria: - non

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Customised testing advice
Customised advice: With Corona related symptoms, get tested at a test facility. If this isn't possible, use a Lateral Flow test.
Regular testing advice
Government guideline testing advice: "With Corona related symptoms, get tested at a test facility".
LFT available
LFT availability: Enough lateral flow tests available at home
No LFT available
LFT availability: No lateral flow tests available at home

Locations

Country Name City State
Netherlands National Institute for Public Health and the Environment Bilthoven Utrecht

Sponsors (1)

Lead Sponsor Collaborator
National Institute for Public Health and the Environment (RIVM)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average strategy sensitivity over time: 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
Primary Maximum average strategy sensitivity over time 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 Willingness to test day 1 Willingness to test on day 1 (LFT & PCR =1, no test = 0), averaged over the four scenario's. Day 1
Secondary Willingness to test - maximum Willingness to test on day 1 and 3 (LFT & PCR =1, no test = 0), averaged over the four scenario's. Day 1 and 3
Secondary Type of test chosen 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
Secondary Type of test chosen 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
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