Respiratory Tract InfectionsNCT02131727
Hand Hygiene Randomized Cluster Intervention to Reduce Infections
A study testing Hand Hygiene Improvement Intervention and Ask Me 3 in people with Respiratory Tract Infections and Gastrointestinal Infections, run by Kent State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections, Gastrointestinal Infections
- What is being tested?
- Hand Hygiene Improvement Intervention and Ask Me 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All employees in respective departments participating in this study were included in the inclusion criteria
Who cannot join
- No employees were excluded if they worked in the participating departments in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Kent State-Cuyahoga County Health Promotion Study
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.
Read the detailed description
The purpose of this study is to determine if a simple random cluster intervention trial 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 those in the intervention group compared to the control group. The intervention was performed among employees in a Midwestern public government setting. Employees in the treatment group received a 3-4 minute training video online that was embedded in the baseline survey. Motivational posters from the USDHHS encouraging proper hand hygiene were installed in the workplace, along with hand hygiene supplies. The control group received a program called "Ask Me 3" developed by the National Patient Safety Foundation; the intervention consisted of a 3-4 minute training video to encourage clear communication with their health care providers, a brochure discussing the Ask Me 3 principles of clear communication with health care providers, and a key-ring with the Ask Me 3 communication principles to promote more effective communication with health care providers at visits out side of work. The groups were followed monthly through surveys over the Internet for an average of three months after baseline to determine if a relative reduction in self-reported respiratory / GI infections occurred in the intervention group compared to the control group.
- Being tested
- Hand Hygiene Improvement Intervention, Ask Me 3
- Keywords
- hand hygiene, communicable diseases, respiratory tract infections, primary prevention, employees
- Medical subject headings
- Respiratory Tract Infections, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Hygiene Improvement InterventionBehavioural
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.
Ask Me 3Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Ask Me 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Monthly surveys for an average of three months
Secondary outcomes (1)
Self-reported usual daily hand hygiene behaviors
Monthly surveys were administered for an average of three months to determine if a relative improvement from self-reported hand hygiene behaviors was seen in the intervention group compared to the control group, from baseline information.
Measured: Monthly self-report surveys for an average of three months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Collaborators
- GoJo Industries, Akron OH, Cuyahoga County Government Center
- Responsible party
- Principal investigator, Maggie Stedman-Smith, Kent State University
- Investigators
- Maggie Stedman-Smith, Ph.D., M.P.H., Principal investigator, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131727
- Sponsor's protocol ID
- 13-050
- Status last verified
- May 2014
- First submitted
- 1 May 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Kent State-Cuyahoga County Health Promotion Study
- ClinicalTrials.gov ID
- NCT02131727
- Acronym / sponsor ID
- 13-050
- Keywords
- hand hygiene, communicable diseases, respiratory tract infections, primary prevention, employees
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Collaborators
- GoJo Industries, Akron OH, Cuyahoga County Government Center
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to determine if a simple random cluster intervention trial 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 those in the intervention group compared to the control group. The intervention was performed among employees in a Midwestern public government setting. Employees in the treatment group received a 3-4 minute training video online that was embedded in the baseline survey. Motivational posters from the USDHHS encouraging proper hand hygiene were installed in the workplace, along with hand hygiene supplies. The control group received a program called "Ask Me 3" developed by the National Patient Safety Foundation; the intervention consisted of a 3-4 minute training video to encourage clear communication with their health care providers, a brochure discussing the Ask Me 3 principles of clear communication with health care providers, and a key-ring with the Ask Me 3 communication principles to promote more effective communication with health care providers at visits out side of work. The groups were followed monthly through surveys over the Internet for an average of three months after baseline to determine if a relative reduction in self-reported respiratory / GI infections occurred in the intervention group compared to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand Hygiene Improvement Intervention | Experimental | Behavioral: Hand Hygiene Improvement InterventionHand 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. |
| Ask Me 3 | Placebo comparator | Behavioral: Ask Me 3Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All employees in respective departments participating in this study were included in the inclusion criteria
Key exclusion criteria (1 listed)
- No employees were excluded if they worked in the participating departments in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand Hygiene Improvement InterventionParticipants 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. | Behavioural | Hand Hygiene Improvement Intervention |
| Ask Me 3Participants 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. | Behavioural | Ask Me 3 |
Primary outcome
Relative reduction in self-reported respiratory and gastrointestinal infections
Time frame: prior 30 days as elicited by self-report on four monthly surveys
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.
Self-reported missed days of work due to symptoms of respiratory and gastrointestinal (GI) infections
Time frame: Monthly surveys for an average of three months
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.
1 secondary outcome
Self-reported usual daily hand hygiene behaviors
Time frame: Monthly self-report surveys for an average of three months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maggie Stedman-Smith, Ph.D., M.P.H. principal investigator
Kent State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Hygiene Improvement Intervention and Ask Me 3 in people with Respiratory Tract Infections and Gastrointestinal Infections, run by Kent State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative reduction in self-reported respiratory and gastrointestinal infections (time frame: prior 30 days as elicited by self-report on four monthly surveys). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014; AzTrials last refreshed its copy on 30 Oct 2026.