Hand Hygiene Intervention Study in Finnish Garrison | NCT01887730

Studies
Hand Hygiene Intervention Study in Finnish Garrison

NCT01887730

Sponsor

Finnish Institute for Health and Welfare

Status

Suspended

Last Update Posted

Aug 27, 2018Actual

Enrollment

1,120Actual

Phase

Not Applicable

Conditions

Infections

Interventions

Hand washing with soap and water
Hand cleaning with alcohol-containing hand rub
Control

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Organizational changes and lack of resources

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Sep 2013Actual

Completion Date

Dec 2020Estimated

First Submitted Date

Jun 19, 2013

First Submission Date that Met QC Criteria

Jun 24, 2013

First Posted Date

Jun 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2018

Last Update Posted Date

Aug 27, 2018Actual

Name	Class
Finnish Defense Forces	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Hand washing with soap and water	Behavioral	Can infections be prevented by hand washing with soap and water	arm 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Length of distinct infection episodes due to infectious disease		8 weeks
Length of distinct absence episodes due to infectious disease.		8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

willingness to attend to the study

Exclusion Criteria:

skin diseases which prevent using hand disinfectants

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carita Savolainen-Kopra	Finnish Institute for Health and Welfare	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vekaranjärvi garrison		Kouvola		46140	Finland

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D003141	Communicable Diseases

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006235	Hand Disinfection
D012915	Soaps
D014867	Water
D000431	Ethanol

Ancestor Terms

ID	Term
D063373	Hand Hygiene
D006920	Hygiene
D011634	Public Health
D004778	Environment and Public Health

Browse Leaves

Not provided

Browse Branches

Not provided