- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04773288
Handy Hygiene of Children: Understanding the Effect of Live Feedback on Handwashing Behavior
February 4, 2022 updated by: Prof. Dr. Thorsten Staake
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
127
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 6 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children aged between 2 and 7 years of age
- children attending kindergarten
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Live feedback provided on display during handwashing
|
Live feedback provided during handwashing on display
|
No Intervention: No live feedback provided during handwashing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to 3 months
|
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).
|
Up to 1 month
|
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.
|
Up to 3 months
|
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).
|
Up to 3 months
|
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.
|
Up to 3 months
|
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).
|
Up to 3 months
|
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.
|
Up to 3 months
|
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.
|
Up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joanna Graichen, M.Sc., Otto-Friedrich-University Bamberg
- Principal Investigator: Anni Pakarinen, PhD, University of Turku
- Principal Investigator: Carlo Stingl, M.Sc., Otto-Friedrich-University Bamberg
- Principal Investigator: Riitta Mieronkoski, University of Turku
- Principal Investigator: Thorsten Staake, Prof. Dr., Otto-Friedrich-University Bamberg
- Principal Investigator: Sanna Salanterä, Prof., University of Turku
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
July 19, 2021
Study Completion (Actual)
July 19, 2021
Study Registration Dates
First Submitted
February 9, 2021
First Submitted That Met QC Criteria
February 23, 2021
First Posted (Actual)
February 26, 2021
Study Record Updates
Last Update Posted (Actual)
February 7, 2022
Last Update Submitted That Met QC Criteria
February 4, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Hand hygiene of children
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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