NCT02131727

Brief Summary

The purpose of this study is to determine if a simple intervention to improve hand hygiene, consisting of a 3-4 minute training video, on-site posters, and hand hygiene supplies, can reduce respiratory and GI illness among employees.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
324

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

May 1, 2014

Last Update Submit

May 4, 2014

Conditions

Keywords

hand hygienecommunicable diseasesrespiratory tract infectionsprimary preventionemployees

Outcome Measures

Primary Outcomes (2)

  • Relative reduction in self-reported respiratory and gastrointestinal infections

    Monthly surveys elicited information among employees in both the intervention and the control group about self-reported usual hand hygiene practices, symptoms of respiratory and GI infections and missed work days due to these symptoms during the prior 30 days. After the close of the study, statistical analysis was conducted to determine relative reductions in the intervention group compared to the control group regarding: self-reported infections and work days missed due to such infections.

    prior 30 days as elicited by self-report on four monthly surveys

  • Self-reported missed days of work due to symptoms of respiratory and gastrointestinal (GI) infections

    Monthly surveys were administered over the Internet for an average of three months to determine if a relative reduction occurred in the intervention group compared to the control group in self-reported missed days from work due to symptoms of respiratory or GI infections.

    Monthly surveys for an average of three months

Secondary Outcomes (1)

  • Self-reported usual daily hand hygiene behaviors

    Monthly self-report surveys for an average of three months from baseline

Study Arms (2)

Hand Hygiene Improvement Intervention

EXPERIMENTAL

Hand Hygiene Improvement Intervention: Participants receive a 4 minute training video about actions to take to reduce risk of respiratory and GI infections that includes hand hygiene practices, along with educational posters and hand hygiene supplies.

Behavioral: Hand Hygiene Improvement Intervention

Ask Me 3

PLACEBO COMPARATOR

Participants in the control group received a 4 minute training video about the Ask Me 3 program for clearer communication with health care providers, a brochure, and a key chain containing principles for clear communication with health care providers.

Behavioral: Ask Me 3

Interventions

Participants received a 4 minute video about protective hand hygiene behaviors and other activities (cough ettiquette, and staying home when ill) to reduce the risk of contracting respiratory tract and GI infections. In addition, motivational posters and hand hygiene supplies were distributed in the work setting.

Hand Hygiene Improvement Intervention
Ask Me 3BEHAVIORAL

Participants in the control group received a 4 minute training video about the "Ask Me 3" program to promote effective communication with health care providers, along with an "Ask Me 3" brochure and a key-chain with the "Ask Me 3" principles for effective communication with health care providers.

Ask Me 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • No employees were excluded if they worked in the participating departments in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kent State University

Kent, Ohio, 44242, United States

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsCommunicable Diseases

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maggie Stedman-Smith, Ph.D., M.P.H.

    Kent State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 1, 2014

First Posted

May 6, 2014

Study Start

February 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations