NCT04773288

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2021

Completed
Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

February 9, 2021

Last Update Submit

February 4, 2022

Conditions

Hand HygieneHandwashing

Outcome Measures

Primary Outcomes (8)

  • 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).

    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).

    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.

    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).

    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.

    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).

    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.

    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.

    Up to 3 months

Study Arms (2)

Live feedback provided on display during handwashing

EXPERIMENTAL
Other: Live feedback during handwashing

No live feedback provided during handwashing

NO INTERVENTION

Interventions

Live feedback during handwashingOTHER

Live feedback provided during handwashing on display

Live feedback provided on display during handwashing

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children aged between 2 and 7 years of age
  • children attending kindergarten

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Turku

Turku, 20520, Finland

Location

Otto-Friedrich-University

Bamberg, 96047, Germany

Location

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Full Professor of Information Systems

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 26, 2021

Study Start

January 1, 2021

Primary Completion

July 19, 2021

Study Completion

July 19, 2021

Last Updated

February 7, 2022

Record last verified: 2022-02

Locations

DE(1)FI(1)