Hand HygieneNCT04773288
Handy Hygiene of Children: Understanding the Effect of Live Feedback on Handwashing Behavior
A study testing Live feedback during handwashing in people with Hand Hygiene and Handwashing, run by Prof. Dr. Thorsten Staake at 2 sites in 2 countries.
Trial summary
Objective of the randomized controlled trial is to assess the impact of a digital intervention on hand hygiene of young children. Children in intervention kindergartens / elementary schools will see live instructions and feedback on their current hand washing activity while washing hands. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Hygiene, Handwashing
- What is being tested?
- Live feedback during handwashing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2021to 19 Jul 2021
- 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged between 2 and 7 years of age
- children attending kindergarten
Who cannot join
- none
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Objective of the randomized controlled trial is to assess the impact of a digital intervention on hand hygiene of young children. Children in intervention kindergartens / elementary schools will see live instructions and feedback on their current hand washing activity while washing hands. We hypothesize that the digital intervention will improve hand hygiene practices of children in kindergarten / elementary school.
- Conditions
- Hand Hygiene, Handwashing
- Being tested
- Live feedback during handwashing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live feedback during handwashingOther
Live feedback provided during handwashing on display
| Study group | Role | What they receive |
|---|---|---|
| Live feedback provided on display during handwashing | Experimental | Not described Receives: Other: Live feedback during handwashing |
| No live feedback provided during handwashing | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main effects of live feedback on handwashing of children
Live feedback is hypothesized to change hand washing activities of children in the short- and long-term. Change in hand washing activity is determined with IoT devices measuring water and soap usage (combined into one measure).
Measured: Up to 3 months
Effect of one-time education session on handwashing of children
One-time educational video is hypothesized to change handwashing activity in the short term but declines with time. Change in hand washing activity is determined with IoT devices measuring water and soap usage (combined into one measure).
Measured: Up to 1 month
Habit formation through live feedback on handwashing of children
Hand washing activities of children are hypothesized to remain changed when live feedback is stopped and in locations where no live feedback is available. Change in hand washing activity is determined with questionnaires for children, parents and educators.
Measured: Up to 3 months
Habit formation through live feedback on handwashing of children
Hand washing activities of children are hypothesized to remain changed when live feedback is stopped and in locations where no live feedback is available. Change in hand washing activity is determined with IoT devices measuring water and soap usage (combined into one measure).
Measured: Up to 3 months
Acquisition of competences of children
Live feedback is hypothesized to change competences of children. Change in hand washing activity is determined with questionnaires for children, parents and educators.
Measured: Up to 3 months
Acquisition of competences of children
Live feedback is hypothesized to change competences of children. Change in hand washing activity is determined with IoT devices measuring water and soap usage (combined into one measure).
Measured: Up to 3 months
Self-efficacy of children
Live feedback is hypothesized to change self-efficacy of children. To be measured with questionnaires for children, parents and educators.
Measured: Up to 3 months
Attitude towards technology of parents
Acquisition of competences perceived by parents is hypothesized to be dependent on their attitude towards digital solutions. To be measured with questionnaires for children, parents and educators.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Jan 2021
- Primary completion19 Jul 2021
- Study completion19 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Thorsten Staake
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku
- Responsible party
- Sponsor-investigator, Prof. Dr. Thorsten Staake, University of Bamberg
- Investigators
- Thorsten Staake, Prof. Dr., Principal investigator, Otto-Friedrich-University BambergJoanna Graichen, M.Sc., Principal investigator, Otto-Friedrich-University BambergCarlo Stingl, M.Sc., Principal investigator, Otto-Friedrich-University BambergSanna Salanterä, Prof., Principal investigator, University of TurkuAnni Pakarinen, PhD, Principal investigator, University of TurkuRiitta Mieronkoski, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773288
- Sponsor's protocol ID
- Hand hygiene of children
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Handy Hygiene of Children: Understanding the Effect of Live Feedback on Handwashing Behavior
- ClinicalTrials.gov ID
- NCT04773288
- Acronym / sponsor ID
- Hand hygiene of children
- Conditions
- Hand Hygiene, Handwashing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Prof. Dr. Thorsten StaakeUniversity, hospital or other
- Collaborators
- University of Turku
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 19 Jul 2021 (actual)
- Study completion
- 19 Jul 2021 (actual)
- First posted
- 26 Feb 2021 (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.
Objective of the randomized controlled trial is to assess the impact of a digital intervention on hand hygiene of young children. Children in intervention kindergartens / elementary schools will see live instructions and feedback on their current hand washing activity while washing hands. We hypothesize that the digital intervention will improve hand hygiene practices of children in kindergarten / elementary school.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Live feedback provided on display during handwashing | Experimental | Other: Live feedback during handwashing |
| No live feedback provided during handwashing | No intervention | – |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children aged between 2 and 7 years of age
- children attending kindergarten
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Live feedback during handwashingLive feedback provided during handwashing on display | Other | Live feedback provided on display during handwashing |
Primary outcome
Main effects of live feedback on handwashing of children
Time frame: Up to 3 months
Live feedback is hypothesized to change hand washing activities of children in the short- and long-term. Change in hand washing activity is determined with IoT devices measuring water and soap usage (combined into one measure).
Effect of one-time education session on handwashing of children
Time frame: Up to 1 month
One-time educational video is hypothesized to change handwashing activity in the short term but declines with time. Change in hand washing activity is determined with IoT devices measuring water and soap usage (combined into one measure).
Habit formation through live feedback on handwashing of children
Time frame: Up to 3 months
Hand washing activities of children are hypothesized to remain changed when live feedback is stopped and in locations where no live feedback is available. Change in hand washing activity is determined with questionnaires for children, parents and educators.
Habit formation through live feedback on handwashing of children
Time frame: Up to 3 months
Hand washing activities of children are hypothesized to remain changed when live feedback is stopped and in locations where no live feedback is available. Change in hand washing activity is determined with IoT devices measuring water and soap usage (combined into one measure).
Acquisition of competences of children
Time frame: Up to 3 months
Live feedback is hypothesized to change competences of children. Change in hand washing activity is determined with questionnaires for children, parents and educators.
Acquisition of competences of children
Time frame: Up to 3 months
Live feedback is hypothesized to change competences of children. Change in hand washing activity is determined with IoT devices measuring water and soap usage (combined into one measure).
Self-efficacy of children
Time frame: Up to 3 months
Live feedback is hypothesized to change self-efficacy of children. To be measured with questionnaires for children, parents and educators.
Attitude towards technology of parents
Time frame: Up to 3 months
Acquisition of competences perceived by parents is hypothesized to be dependent on their attitude towards digital solutions. To be measured with questionnaires for children, parents and educators.
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 7 Feb 2022.
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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.
Thorsten Staake, Prof. Dr. principal investigator
Otto-Friedrich-University Bamberg
Joanna Graichen, M.Sc. principal investigator
Otto-Friedrich-University Bamberg
Carlo Stingl, M.Sc. principal investigator
Otto-Friedrich-University Bamberg
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live feedback during handwashing in people with Hand Hygiene and Handwashing, run by Prof. Dr. Thorsten Staake at 2 sites in 2 countries.
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 2 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 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, Germany. 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?
Main effects of live feedback on handwashing of children (time frame: Up to 3 months). The study lists 8 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 7 Feb 2022.