NCT01887730

Brief Summary

In this study the investigators aim to elucidate the possibility to reduce occurrence of infectious diseases in a garrison with enhanced and guided hand hygiene. The investigators will study occurrence and transmission of infections. In addition, the investigators will find out the causative agents of infections in a garrison with virological analyses of naso-pharyngeal and fecal specimens. The costs of lost service days and other expenses due to infectious diseases will be evaluated with a cost analysis study.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
1,120

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

June 19, 2013

Last Update Submit

August 23, 2018

Conditions

Keywords

Hand HygieneCommunicable DiseasesPrevention

Outcome Measures

Primary Outcomes (1)

  • Number of infection episodes during basic training period. The periods when a person has been in duty in spite of the infection will be included.

    8 weeks

Secondary Outcomes (2)

  • Length of distinct infection episodes due to infectious disease

    8 weeks

  • Length of distinct absence episodes due to infectious disease.

    8 weeks

Study Arms (3)

arm 2

ACTIVE COMPARATOR

Hand washing with soap and water according to instructions. The effect of intervention is assessed by following occurrence of infections.

Behavioral: Hand washing with soap and water

arm 0

PLACEBO COMPARATOR

No specific advice on hand hygiene. The effect of intervention is assessed by following occurrence of infections.

Behavioral: Control

Arm 3

ACTIVE COMPARATOR

Hand cleaning with alcohol-containing hand rub

Behavioral: Hand cleaning with alcohol-containing hand rub

Interventions

Can infections be prevented by hand washing with soap and water

arm 2

Can infections be prevented by hand cleaning with alcohol-containing hand rub. Effect of intervention is assessed by following occurrence of infections

Arm 3
ControlBEHAVIORAL
arm 0

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • willingness to attend to the study

You may not qualify if:

  • skin diseases which prevent using hand disinfectants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vekaranjärvi garrison

Kouvola, 46140, Finland

Location

MeSH Terms

Conditions

InfectionsCommunicable Diseases

Interventions

Hand DisinfectionSoapsWaterEthanol

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hand HygieneHygienePublic HealthEnvironment and Public HealthDetergentsSurface-Active AgentsSpecialty Uses of ChemicalsChemical Actions and UsesHousehold ProductsTechnology, Industry, and AgricultureHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsAlcoholsOrganic Chemicals

Study Officials

  • Carita Savolainen-Kopra

    Finnish Institute for Health and Welfare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2013

First Posted

June 27, 2013

Study Start

January 1, 2012

Primary Completion

September 1, 2013

Study Completion

December 1, 2020

Last Updated

August 27, 2018

Record last verified: 2018-08

Locations