Handy Hygiene of Children: Understanding the Effect of Live Feedback on Handwashing Behavior

• Sponsor: Prof. Dr. Thorsten Staake (Other)
• Overall Status: Completed
• CT.gov ID: NCT04773288
• Collaborator: University of Turku (Other)
• Enrollment: 127
• Locations: 2
• Arms: 2
• Actual Duration (Months): 6.5
• Patients Per Site: 63.5
• Patients Per Site Per Month: 9.7

Study Details

Study Description

Brief 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. We hypothesize that the digital intervention will improve hand hygiene practices of children in kindergarten / elementary school.

Condition or Disease	Intervention/Treatment	Phase
Hand Hygiene; Handwashing	Other: Live feedback during handwashing	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 127 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Other
• Official Title: Handy Hygiene of Children: Understanding the Effect of Live Feedback on Handwashing Behavior
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Jul 19, 2021
• Actual Study Completion Date: Jul 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Live feedback provided on display during handwashing	Other: Live feedback during handwashing; Live feedback provided during handwashing on display
No Intervention: No live feedback provided during handwashing

Outcome Measures

Primary Outcome Measures

1. Main effects of live feedback on handwashing of children [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).

2. Effect of one-time education session on handwashing of children [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).

3. Habit formation through live feedback on handwashing of children [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.

4. Habit formation through live feedback on handwashing of children [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).

5. Acquisition of competences of children [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.

6. Acquisition of competences of children [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).

7. Self-efficacy of children [Up to 3 months]

   Live feedback is hypothesized to change self-efficacy of children. To be measured with questionnaires for children, parents and educators.

8. Attitude towards technology of parents [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• children aged between 2 and 7 years of age

• children attending kindergarten

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Turku	Turku		Finland	20520
2	Otto-Friedrich-University	Bamberg		Germany	96047

Sponsors and Collaborators

• Prof. Dr. Thorsten Staake
• University of Turku

Investigators

• Principal Investigator: Thorsten Staake, Prof. Dr., Otto-Friedrich-University Bamberg
• Principal Investigator: Joanna Graichen, M.Sc., Otto-Friedrich-University Bamberg
• Principal Investigator: Carlo Stingl, M.Sc., Otto-Friedrich-University Bamberg
• Principal Investigator: Sanna Salanterä, Prof., University of Turku
• Principal Investigator: Anni Pakarinen, PhD, University of Turku
• Principal Investigator: Riitta Mieronkoski, University of Turku

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Dr. Thorsten Staake, Full Professor of Information Systems, University of Bamberg
• ClinicalTrials.gov Identifier: NCT04773288
• Other Study ID Numbers: Hand hygiene of children
• First Posted: Feb 26, 2021
• Last Update Posted: Feb 7, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 7, 2022