Adherence to WHO-advised Hygiene-related BehaviorNCT04442217
Factors Associated With Adherence to Hygiene-related Behaviors and Viral Mitigation Protocols During the COVID-19 Pandemic
An observational study of Adherence to WHO-advised Hygiene-related Behavior and Adherence to Viral Mitigation Protocols, run by University of Oslo.
Trial summary
Study description: The preset study seeks to investigate factors associated with of hygiene-related behaviors and adherence to viral mitigation protocols during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adherence to WHO-advised Hygiene-related Behavior, Adherence to Viral Mitigation Protocols
- What is being tested?
- Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2020to 13 Jul 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adults above 18 years residing in Norway and thus experiencing identical mitigation protocols are invited to participate the study, reaching randomly online with an equal opportunity of participating.
Who may be able to join
- Eligible participants are all adults including those of 18 years and above,
- Who are currently living in Norway and thus experiencing identical NPIs, and
- Who provide digital consent to partake in the study.
Who cannot join
- Children and adolescents (individuals below 18)
- Adults not residing in Norway during the measurement period
Trial locations and contacts
No sites are listed yet.
About this study
Study description:
The preset study seeks to investigate factors associated with of hygiene-related behaviors and adherence to viral mitigation protocols during the COVID-19 pandemic. In particular, factors associated with of adherence to WHO-advised hygiene-related behaviors and adherence to governmental mitigation protocols are investigations.
Read more
The aim of the project is to:
- Inform the policymakers, the general public, scientists, and health practitioners about the cognitive, behavioral, emotional, motivational, and trait components underlying hygiene-related behaviors and adherence.
- Help policymakers better understand adherence and the factors it is associated with, providing empirical grounds to advance societies battle against the COVID-19-virus from an epidemiological perspective by promoting factors that increase adherence.
Hypothesis/Research questions Hypothesis 1: Risk perception, altruism and governmental trust will significantly be associated with both adherence and hygiene-related behavior, with increased risk perception, altruism, and governmental trust associated with higher rates of adherence and hygiene-related behavior. The personality traits conscientiousness and agreeableness will significantly be associated with both adherence and hygiene related behavior, with increased conscientiousness, and agreeableness associated with higher rates of adherence and hygiene-related behavior. Furthermore, beliefs about pandemic protocol efficacy and beliefs about collective mitigation behavior (i.e., "it is only useful to follow transmission protocols if everyone else does") will be associated with adherence to viral mitigation protocols and hygiene-related behaviors.
Research Question 1: Is there a difference between the use of various platforms to obtain information about COVID with regards to adherence to viral mitigation protocols and hygiene-related behaviors? Research Question 2: To what extend are different sources of obtaining information associated with adherence to hygiene-related behavior and adherence to viral mitigation protocols? Research Question 3: To what extent are different personality traits (measured with the Short Big Five Inventory-10 (BFI-10)) associated with adherence to viral mitigation protocols and hygiene-related behaviors?
Read the detailed description
Hypothesis/Research questions Hypothesis 1: Risk perception, altruism and governmental trust will significantly be associated with both adherence and hygiene-related behavior, with increased risk perception, altruism, and governmental trust associated with higher rates of adherence and hygiene-related behavior. The personality traits conscientiousness and agreeableness will significantly be associated with both adherence and hygiene related behavior, with increased conscientiousness, and agreeableness associated with higher rates of adherence and hygiene-related behavior. Furthermore, beliefs about pandemic protocol efficacy and beliefs about collective mitigation behavior (i.e., "it is only useful to follow transmission protocols if everyone else does") will be associated with adherence to viral mitigation protocols and hygiene-related behaviors.
Research Question 1: Is there a difference between the use of various platforms to obtain information about COVID with regards to adherence to viral mitigation protocols and hygiene-related behaviors? Research Question 2: To what extend are different sources of obtaining information associated with adherence to hygiene-related behavior and adherence to viral mitigation protocols? Research Question 3: To what extent are different personality traits (measured with the Short Big Five Inventory-10 (BFI-10)) associated with adherence to viral mitigation protocols and hygiene-related behaviors?
Statistical analyses:
Two hierarchical regression analyses will be conducted: one with adherence to hygiene-related behavior as the dependent variable, and the second with adherence to pandemic protocols as the dependent variable. In both hierarchical regression analysis, the first step will include the demographic characteristics (control variables) age, gender, and education. The second step will include risk perception, altruism, governmental trust, personality traits (i.e., neuroticism, extroversion-introversion, openness, conscientiousness, agreeableness), beliefs about pandemic protocol efficacy and beliefs about collective mitigation behavior.
Part correlations will be reported, presenting the effect size of the hypothesized predictors on adherence, revealing the most important variables related to adherence behavior. Multicollinearity and other statistical assumptions will be checked using examined. Multicollinearity will be assessed with common guidelines (VIF < 5 and Tolerance > 0.2; Hocking, 2003; O'Brian, 2007).
All analyses and questions addressed in the forthcoming paper that are not pre-specified in this pre-registered protocol will be defined as exploratory.
Sensitivity analyses and random subsample replications of the main findings will be conducted following selection of a random sample of participants that ensure a proportionate ratio between the collected sample and the adult population of Norway.
Possible transformations:
All variables will be assessed in their original and validated format as is recommended practice, as long as this is possible with regards to statistical assumptions underlying the pre-defined analyses (i.e., multiple regression). However, if this is not possible with regards to the statistical assumptions behind the analyses, transformation (e.g., square root or log-transformations) may be needed to apply interval-based methods. The investigators will examine the degree of skewness and evaluate this against the assumptions and analyses before choosing the appropriate analysis. The pre-registered and planned analyses include multiple regression as long as the assumptions underlying these analyses are met. Alternatively, a non-parametric test will be used.
Inference criteria Given the large sample size in this study, the investigators pre-define their significance level: p < 0.01 to determine significance.
Sample size and power calculation:
The present study is part of a larger project with the first part aiming to investigate predictors of adherence through regression analyses, and the second part aiming to examine directional relations amongst specific symptoms and their centrality through complex systems approaches (i.e., network analysis). Consequently, power calculations are based on power required for network analyses. Following power analysis guidelines by Fried \& Cramer (2017), it is recommended that the number of participants are three times larger than the number of estimated parameters. However, more conservative recommendations by Roscoe (1975) for multivariate research, recommends sample size that is ten times larger than the number of estimated parameters. Thus, following these two approaches respectively, between 1395 to 4650 participants are required. Data will be collected for three weeks, and participants are based on a representative and random sample of Norwegian adults, randomly selected and provided equal opportunity to partake in the study, providing digital consent.
Missing data:
The TSD system (Services for Sensitive Data), a platform used in Norway to store person-sensitive data verifies participants officially through a kind of national ID number to give them full right to withdraw their data at any time, following the European GDPR (General Data Protection Regulation) laws. Accordingly, participants are allowed to withdraw their own data at any time. The survey includes mandatory fields of response. Participation is voluntarily, and withdrawal of provided data is possible at any moment. The investigators do not expect participants to withdraw their data and thus expect no missing data. However, if participants do withdraw their data, The investigators will conduct state-of-art missing data analyses and investigate whether data is missing at random.
Variables:
Outcome measures: as described in primary outcome measures section: 1) adherence to viral mitigation protocols; and 2) adherence to WHO-recommended hygiene-related behaviors.
Predictors: All 5 Big Five Personality Traits are measured by the validated Brief Version of the Big Five Personality Inventory (BFI-10). Risk perception is measured with a three-item measure adapted for the COVID-19 pandemic, querying about the perceived risk of the COVID-19 virus for 1) oneself; 2) other individuals; and 3) society at large. Governmental trust is measured with a single item adapted for the COVID-19 pandemic, querying about the whether one trusts in the governments judgements and decisions concerning handling of the pandemic. Altruism is measured with a single item adapted for the pandemic, querying about personal importance given to helping society and peers. Beliefs about protocol efficacy and beliefs about collective mitigation behavior are both measured with single items adapted for the COVID-19 pandemic, querying about beliefs concerning the efficacy of initiated protocols against the pandemic and beliefs about perceived usefulness of adhering when a proportion of others do not.
- Conditions
- Adherence to WHO-advised Hygiene-related Behavior, Adherence to Viral Mitigation Protocols
- Being tested
- Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental healthBehavioural
Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to WHO-advised hygiene-related
Adherence to WHO-advised hygiene related behavior is measured with 7 items querying about hygiene-related behavior as recommended by the WHO, measured with on a 5-point likert scale, measuring the frequency of these behaviors for the past month (0 = not at all to 4 = Every day)
Measured: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.
Adherence to viral mitigation protocols
- Adherence to viral mitigation protocols is measured with 5 items querying about adherence to mitigation protocols initiated by the Norwegian government, measured with on a 5-point likert scale, measuring the frequency of adherence to these protocols for the past month (0 = not at all to 4 = Every day).
Measured: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start22 Jun 2020 (estimated)
- Primary completion13 Jul 2020 (estimated)
- Study completion13 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence to WHO-advised Hygiene-related BehaviorStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Modum Bad
- Responsible party
- Principal investigator, Omid V. Ebrahimi, University of Oslo
- Investigators
- Omid V. Ebrahimi, Double PhD Candidate, Principal investigator, University of OsloSverre Urnes Johnson, PhD, Principal investigator, University of OsloAsle Hoffart, PhD, Principal investigator, Modum Bad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442217
- Sponsor's protocol ID
- REK125510-11
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Adherence to Hygiene-related Behaviors and Viral Mitigation Protocols During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04442217
- Acronym / sponsor ID
- REK125510-11
- Conditions
- Adherence to WHO-advised Hygiene-related Behavior, Adherence to Viral Mitigation Protocols
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Modum Bad
- Study start
- 22 Jun 2020 (estimated)
- Primary completion
- 13 Jul 2020 (estimated)
- Study completion
- 13 Jul 2020 (estimated)
- First posted
- 22 Jun 2020 (actual)
- 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 description:
The preset study seeks to investigate factors associated with of hygiene-related behaviors and adherence to viral mitigation protocols during the COVID-19 pandemic. In particular, factors associated with of adherence to WHO-advised hygiene-related behaviors and adherence to governmental mitigation protocols are investigations.
The aim of the project is to:
- Inform the policymakers, the general public, scientists, and health practitioners about the cognitive, behavioral, emotional, motivational, and trait components underlying hygiene-related behaviors and adherence.
- Help policymakers better understand adherence and the factors it is associated with, providing empirical grounds to advance societies battle against the COVID-19-virus from an epidemiological perspective by promoting factors that increase adherence.
Hypothesis/Research questions Hypothesis 1: Risk perception, altruism and governmental trust will significantly be associated with both adherence and hygiene-related behavior, with increased risk perception, altruism, and governmental trust associated with higher rates of adherence and hygiene-related behavior. The personality traits conscientiousness and agreeableness will significantly be associated with both adherence and hygiene related behavior, with increased conscientiousness, and agreeableness associated with higher rates of adherence and hygiene-related behavior. Furthermore, beliefs about pandemic protocol efficacy and beliefs about collective mitigation behavior (i.e., "it is only useful to follow transmission protocols if everyone else does") will be associated with adherence to viral mitigation protocols and hygiene-related behaviors.
Research Question 1: Is there a difference between the use of various platforms to obtain information about COVID with regards to adherence to viral mitigation protocols and hygiene-related behaviors? Research Question 2: To what extend are different sources of obtaining information associated with adherence to hygiene-related behavior and adherence to viral mitigation protocols? Research Question 3: To what extent are different personality traits (measured with the Short Big Five Inventory-10 (BFI-10)) associated with adherence to viral mitigation protocols and hygiene-related behaviors?
Detailed description
Hypothesis/Research questions Hypothesis 1: Risk perception, altruism and governmental trust will significantly be associated with both adherence and hygiene-related behavior, with increased risk perception, altruism, and governmental trust associated with higher rates of adherence and hygiene-related behavior. The personality traits conscientiousness and agreeableness will significantly be associated with both adherence and hygiene related behavior, with increased conscientiousness, and agreeableness associated with higher rates of adherence and hygiene-related behavior. Furthermore, beliefs about pandemic protocol efficacy and beliefs about collective mitigation behavior (i.e., "it is only useful to follow transmission protocols if everyone else does") will be associated with adherence to viral mitigation protocols and hygiene-related behaviors.
Research Question 1: Is there a difference between the use of various platforms to obtain information about COVID with regards to adherence to viral mitigation protocols and hygiene-related behaviors? Research Question 2: To what extend are different sources of obtaining information associated with adherence to hygiene-related behavior and adherence to viral mitigation protocols? Research Question 3: To what extent are different personality traits (measured with the Short Big Five Inventory-10 (BFI-10)) associated with adherence to viral mitigation protocols and hygiene-related behaviors?
Statistical analyses:
Two hierarchical regression analyses will be conducted: one with adherence to hygiene-related behavior as the dependent variable, and the second with adherence to pandemic protocols as the dependent variable. In both hierarchical regression analysis, the first step will include the demographic characteristics (control variables) age, gender, and education. The second step will include risk perception, altruism, governmental trust, personality traits (i.e., neuroticism, extroversion-introversion, openness, conscientiousness, agreeableness), beliefs about pandemic protocol efficacy and beliefs about collective mitigation behavior.
Part correlations will be reported, presenting the effect size of the hypothesized predictors on adherence, revealing the most important variables related to adherence behavior. Multicollinearity and other statistical assumptions will be checked using examined. Multicollinearity will be assessed with common guidelines (VIF < 5 and Tolerance > 0.2; Hocking, 2003; O'Brian, 2007).
All analyses and questions addressed in the forthcoming paper that are not pre-specified in this pre-registered protocol will be defined as exploratory.
Sensitivity analyses and random subsample replications of the main findings will be conducted following selection of a random sample of participants that ensure a proportionate ratio between the collected sample and the adult population of Norway.
Possible transformations:
All variables will be assessed in their original and validated format as is recommended practice, as long as this is possible with regards to statistical assumptions underlying the pre-defined analyses (i.e., multiple regression). However, if this is not possible with regards to the statistical assumptions behind the analyses, transformation (e.g., square root or log-transformations) may be needed to apply interval-based methods. The investigators will examine the degree of skewness and evaluate this against the assumptions and analyses before choosing the appropriate analysis. The pre-registered and planned analyses include multiple regression as long as the assumptions underlying these analyses are met. Alternatively, a non-parametric test will be used.
Inference criteria Given the large sample size in this study, the investigators pre-define their significance level: p < 0.01 to determine significance.
Sample size and power calculation:
The present study is part of a larger project with the first part aiming to investigate predictors of adherence through regression analyses, and the second part aiming to examine directional relations amongst specific symptoms and their centrality through complex systems approaches (i.e., network analysis). Consequently, power calculations are based on power required for network analyses. Following power analysis guidelines by Fried \& Cramer (2017), it is recommended that the number of participants are three times larger than the number of estimated parameters. However, more conservative recommendations by Roscoe (1975) for multivariate research, recommends sample size that is ten times larger than the number of estimated parameters. Thus, following these two approaches respectively, between 1395 to 4650 participants are required. Data will be collected for three weeks, and participants are based on a representative and random sample of Norwegian adults, randomly selected and provided equal opportunity to partake in the study, providing digital consent.
Missing data:
The TSD system (Services for Sensitive Data), a platform used in Norway to store person-sensitive data verifies participants officially through a kind of national ID number to give them full right to withdraw their data at any time, following the European GDPR (General Data Protection Regulation) laws. Accordingly, participants are allowed to withdraw their own data at any time. The survey includes mandatory fields of response. Participation is voluntarily, and withdrawal of provided data is possible at any moment. The investigators do not expect participants to withdraw their data and thus expect no missing data. However, if participants do withdraw their data, The investigators will conduct state-of-art missing data analyses and investigate whether data is missing at random.
Variables:
Outcome measures: as described in primary outcome measures section: 1) adherence to viral mitigation protocols; and 2) adherence to WHO-recommended hygiene-related behaviors.
Predictors: All 5 Big Five Personality Traits are measured by the validated Brief Version of the Big Five Personality Inventory (BFI-10). Risk perception is measured with a three-item measure adapted for the COVID-19 pandemic, querying about the perceived risk of the COVID-19 virus for 1) oneself; 2) other individuals; and 3) society at large. Governmental trust is measured with a single item adapted for the COVID-19 pandemic, querying about the whether one trusts in the governments judgements and decisions concerning handling of the pandemic. Altruism is measured with a single item adapted for the pandemic, querying about personal importance given to helping society and peers. Beliefs about protocol efficacy and beliefs about collective mitigation behavior are both measured with single items adapted for the COVID-19 pandemic, querying about beliefs concerning the efficacy of initiated protocols against the pandemic and beliefs about perceived usefulness of adhering when a proportion of others do not.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adults above 18 years residing in Norway and thus experiencing identical mitigation protocols are invited to participate the study, reaching randomly online with an equal opportunity of participating.
Key inclusion criteria (3 listed)
- Eligible participants are all adults including those of 18 years and above,
- Who are currently living in Norway and thus experiencing identical NPIs, and
- Who provide digital consent to partake in the study.
Key exclusion criteria (2 listed)
- Children and adolescents (individuals below 18)
- Adults not residing in Norway during the measurement period
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 |
|---|---|---|
| Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental healthProspective study with two measurement points investigating the impact of viral mitigation protocols on mental health | Behavioural | – |
Primary outcome
Adherence to WHO-advised hygiene-related
Time frame: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.
Adherence to WHO-advised hygiene related behavior is measured with 7 items querying about hygiene-related behavior as recommended by the WHO, measured with on a 5-point likert scale, measuring the frequency of these behaviors for the past month (0 = not at all to 4 = Every day)
Adherence to viral mitigation protocols
Time frame: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.
o Adherence to viral mitigation protocols is measured with 5 items querying about adherence to mitigation protocols initiated by the Norwegian government, measured with on a 5-point likert scale, measuring the frequency of adherence to these protocols for the past month (0 = not at all to 4 = Every day).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
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.
Omid V. Ebrahimi, Double PhD Candidate principal investigator
University of Oslo
Sverre Urnes Johnson, PhD principal investigator
University of Oslo
Asle Hoffart, PhD principal investigator
Modum Bad
Questions about this trial
What is this clinical trial studying?
An observational study of Adherence to WHO-advised Hygiene-related Behavior and Adherence to Viral Mitigation Protocols, run by University of Oslo.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omid V. Ebrahimi, Double PhD Candidate (+47-22845295, omideb@uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to WHO-advised hygiene-related (time frame: Data is set to be collected starting from 22nd of June until enough data has been collected. The data collection period will last no longer than three weeks.). The study lists 2 primary outcomes in all. 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 23 Jun 2020.