HygieneNCT04382690
Behavioral Determinants That May Influence People's Hand-hygiene and Environment Disinfecting
An observational study of Hygiene, run by University of Warwick at 1 site in United Kingdom.
Trial summary
An anonymous online survey will be conducted to measure the barriers and facilitators parents and teachers experience to positively influencing children's hand-hygiene. A sub-section of the survey will also examine the barriers and facilitators they experience to surface cleaning. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hygiene
- What is being tested?
- All participants will be asked to respond to the same survey questions
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,975 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 May 2020to 30 Jun 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: Participants will be residents of one of the following countries: Australia, China, India, Indonesia, Saudi Arabia, South Africa, and the United Kingdom.
Who may be able to join
- be 18 years or older;
- identify as a female or male; and
- be either a teacher or parent of children between 5 and 10 years old.
Who cannot join
- be 17 years or younger;
- not identify as a female or male; and
- not be a teacher or parent of children between 5 and 10 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surveys of the Behavioral Determinants That May Influence People's Hand-hygiene and Environment Disinfecting in Different Countries
An anonymous online survey will be conducted to measure the barriers and facilitators parents and teachers experience to positively influencing children's hand-hygiene. A sub-section of the survey will also examine the barriers and facilitators they experience to surface cleaning. The final survey will be conducted with participants from Australia, China, India, Indonesia, Saudi Arabia, South Africa, and the United Kingdom. The data collected will be completely anonymous and there are no sensitive questions. The primary and secondary analyses will focus on the hand-hygiene items to examine the survey's internal and external validity. The results will inform a future school-based intervention.
- Conditions
- Hygiene
- Being tested
- All participants will be asked to respond to the same survey questions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All participants will be asked to respond to the same survey questionsBehavioural
All participants will be asked to respond to the same survey questions
| Study group | Role | What they receive |
|---|---|---|
| India | People residing in India Receives: Behavioral: All participants will be asked to respond to the same survey questions | |
| United Kingdom | People residing in the United Kingdom Receives: Behavioral: All participants will be asked to respond to the same survey questions | |
| China | People residing in China Receives: Behavioral: All participants will be asked to respond to the same survey questions | |
| Australia | People residing in Australia Receives: Behavioral: All participants will be asked to respond to the same survey questions | |
| South Africa | People residing in South Africa Receives: Behavioral: All participants will be asked to respond to the same survey questions | |
| Indonesia | People residing in Indonesia Receives: Behavioral: All participants will be asked to respond to the same survey questions | |
| Saudi Arabia | People residing in Saudi Arabia Receives: Behavioral: All participants will be asked to respond to the same survey questions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Theoretical Domains Framework Barriers/Facilitators
Participants' agreements with survey statements about the barriers and facilitators they expereince to positively influecing children's hand hygeine and surface cleaning. Each response is given on a 5 point scale from strongly disagree to strongly agree. Some statements will be reverse scored.
Measured: Reported during the survey on Day 1
Secondary outcomes (3)
Self-reported confience in positively influencing children's hygeine when they are watching
Participants' responses to the following question: When your [children/pupils] can see you watching them, what percentage of the time do they wash their hands with soap and water after going to the toilet and before eating? [response options 0% - 100%]
Measured: Reported during the survey on Day 1
Self-reported confience in positively influencing children's hygeine when they are not watching
Participants' responses to the following question: When your [children/pupils] cannot see you watching them, what percentage of the time do they wash their hands with soap and water after going to the toilet and before eating?'[response options 0 - 100%]
Measured: Reported during the survey on Day 1
Self-reported hygiene
Participants' responses to the following question: What percentage of the time do you wash your own hands with soap and water after going to the toilet and before eating? [response options 0-100%]
Measured: Reported during the survey on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start27 May 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HygieneStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,975 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warwick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Ann Schmidtke, University of Warwick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382690
- Sponsor's protocol ID
- 8304
- Status last verified
- Jul 2020
- First submitted
- 25 Apr 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveys of the Behavioral Determinants That May Influence People's Hand-hygiene and Environment Disinfecting in Different Countries
- ClinicalTrials.gov ID
- NCT04382690
- Acronym / sponsor ID
- 8304
- Conditions
- Hygiene
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,975 participants (actual)
- Lead sponsor
- University of WarwickUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 11 May 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.
An anonymous online survey will be conducted to measure the barriers and facilitators parents and teachers experience to positively influencing children's hand-hygiene. A sub-section of the survey will also examine the barriers and facilitators they experience to surface cleaning. The final survey will be conducted with participants from Australia, China, India, Indonesia, Saudi Arabia, South Africa, and the United Kingdom. The data collected will be completely anonymous and there are no sensitive questions. The primary and secondary analyses will focus on the hand-hygiene items to examine the survey's internal and external validity. The results will inform a future school-based intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| India | – | Behavioral: All participants will be asked to respond to the same survey questionsPeople residing in India |
| United Kingdom | – | Behavioral: All participants will be asked to respond to the same survey questionsPeople residing in the United Kingdom |
| China | – | Behavioral: All participants will be asked to respond to the same survey questionsPeople residing in China |
| Australia | – | Behavioral: All participants will be asked to respond to the same survey questionsPeople residing in Australia |
| South Africa | – | Behavioral: All participants will be asked to respond to the same survey questionsPeople residing in South Africa |
| Indonesia | – | Behavioral: All participants will be asked to respond to the same survey questionsPeople residing in Indonesia |
| Saudi Arabia | – | Behavioral: All participants will be asked to respond to the same survey questionsPeople residing in Saudi Arabia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be residents of one of the following countries: Australia, China, India, Indonesia, Saudi Arabia, South Africa, and the United Kingdom.
Key inclusion criteria (3 listed)
- be 18 years or older;
- identify as a female or male; and
- be either a teacher or parent of children between 5 and 10 years old.
Key exclusion criteria (3 listed)
- be 17 years or younger;
- not identify as a female or male; and
- not be a teacher or parent of children between 5 and 10 years old.
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 |
|---|---|---|
| All participants will be asked to respond to the same survey questionsAll participants will be asked to respond to the same survey questions | Behavioural | Australia, China, India, Indonesia, Saudi Arabia, South Africa, United Kingdom |
Primary outcome
Theoretical Domains Framework Barriers/Facilitators
Time frame: Reported during the survey on Day 1
Participants' agreements with survey statements about the barriers and facilitators they expereince to positively influecing children's hand hygeine and surface cleaning. Each response is given on a 5 point scale from strongly disagree to strongly agree. Some statements will be reverse scored.
3 secondary outcomes
Self-reported confience in positively influencing children's hygeine when they are watching
Time frame: Reported during the survey on Day 1
Self-reported confience in positively influencing children's hygeine when they are not watching
Time frame: Reported during the survey on Day 1
Self-reported hygiene
Time frame: Reported during the survey on Day 1
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 23 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hygiene, run by University of Warwick at 1 site in United Kingdom.
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 3 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 23 Jul 2020. 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 United Kingdom. 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?
Theoretical Domains Framework Barriers/Facilitators (time frame: Reported during the survey on Day 1). 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 Jul 2020.