Acute Respiratory InfectionNCT03454009
Kent State University / Price Chopper Employee Wellness Study
A study testing Multimodal hygiene intervention in people with Acute Respiratory Infection and Influenza-like Illness, run by Kent State University at 1 site in United States.
Trial summary
This is a comprehensive randomized cluster hand-hygiene improvement intervention to reduce: self-reported acute respiratory tract infections (ARI) / influenza-like-illness (ILI) and gastrointestinal (GI) illness, absenteeism, presenteeism; and related behavioral and attitudinal change over a 90 day trial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Infection, Influenza-like Illness, Gastrointestinal Infection
- What is being tested?
- Multimodal hygiene intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 11 May 2018
- 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
- At least 18 years or older
- No known allergies to alcohol or surface disinfecting wipes;
- Works at least 30% of office hours at the study host site;
- Consent to receiving emails from Kent State University.
Who cannot join
- Under 18 years of age;
- Known allergies to alcohol or surface disinfecting wipes;
- Works less than 30% of office hours at the study host site;
- Does not consent to receiving emails from Kent State University.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Golub Corporation (Price Chopper / Market 32)
Schenectady, New York, 12308
About this study
Official title: Kent State University / Price Chopper Wellness Promotion Study
This is a comprehensive randomized cluster hand-hygiene improvement intervention to reduce: self-reported acute respiratory tract infections (ARI) / influenza-like-illness (ILI) and gastrointestinal (GI) illness, absenteeism, presenteeism; and related behavioral and attitudinal change over a 90 day trial. The Intervention group will receive hand hygiene supplies, and a variety of educational materials, including environmental posters in common areas. The control group will perform their usual hygiene activities and will not receive an intervention.
Identical weekly surveys will be administered to the intervention and control groups to measure self-reported illness, absenteeism, presenteeism, along with behavior and attitudes measured at specified intervals during the study. The intervention and control groups were randomized by work floors before the onset of the enrollment period. It is hypothesized that employees in the intervention group will experience reduced self-reported illness, absenteeism and presenteeism along with improved protective hygiene behaviors and related attitudes, relative to those in the control group over the 90-day trial.
Read the detailed description
The annual costs of seasonal influenza in the United States have been estimated at $87.1 billion, while costs from the common cold have been estimated at $40 billion. Office employees are at increased risk for contracting communicable disease at work, since they spend nearly half of their waking hours in this setting, work in close proximity with each other, and share equipment. Furthermore, employers in the U.S. have a compelling interest to reduce the spread of infectious disease, because they pay for the direct and indirect costs of absenteeism in employee wages, replacement of staff, reduced quality of services, rising health care premiums, and if self-insured, direct health care expenditures.
Hand hygiene is the single most important action to reduce the transmission of pathogens that result in healthcare acquired infections. Moreover, hand hygiene and respiratory etiquette have been recommended as primary non-pharmaceutical strategies in the early stages of an epidemic before a suitable vaccine is available. While influenza vaccine uptake is the most important recommendation to prevent influenza, the vaccine only protects against 3 or 4 of the most prevalent circulating strains in a given flu season and does not provide protection against non-influenza viral and bacterial pathogens. Meta-analysis has shown that numerous community intervention studies in schools, daycare, and private homes have reduced illness from infectious disease by 21-31%.
Despite the enormous burdens from communicable disease and the importance of the workplace as a setting for the potential spread of infections, to date, only four randomized control trials have been performed world-wide among office-based employees to assess the efficacy of hand hygiene interventions to reduce the spread of communicable disease, including acute respiratory infections (ARI), influenza-like illness (ILI) and gastrointestinal infections. Collectively, these interventions have shown promising results. Hubner and colleagues (2010) found a 65% reduction in the odds of contracting the common cold among workers with improved hand hygiene in a public administrative setting in Germany while Savolainen-Kopra and colleagues (2012) found a reduction in infectious illness among office employees in Finland who participated in a study arm that utilized soap and water and educational training. In the U.S., Stedman-Smith and colleagues (2015) found a 31% significant reduction in self-reported ARI / ILI and gastrointestinal illness combined in a multi-modal hand hygiene pilot randomized cluster trial among office employees at a Midwestern government center. While, Arbogast and colleagues (2016) found a significant reduction in health care claims for communicable infections spread by hand-to-mouth modes of transmissions over a 13-month, multi-component hand hygiene trial which utilized education, hand sanitizer and disinfectant wipes.
This is a comprehensive non-pharmaceutical randomized cluster hygiene improvement intervention to reduce self-reported acute respiratory tract infections (ARIs) / influenza-like-illness (ILI) and gastrointestinal (GI) illness, absenteeism, and presenteeism over a 90-day trial. The Intervention group will receive hygiene supplies (hand sanitizer, surface disinfectant wipes, tissues) and educational materials in varied mediums, including brief educational videos, and motivational posters hung in common work areas, in addition to hand sanitizer, along with hand sanitizer and surface disinfectant wipes installed in shared work areas. The control group will perform their usual hygiene activities and will not receive an intervention. Predominate pathways for the spread of ARI/ILI and non-foodborne GI infections include: (1) droplets that land on the nose, mouth, or are inhaled from infected persons' who cough, sneeze or talk; or (2) pathogens on hands contaminated from fomites or from touching infected persons, which come in contact with portals of entry including the mouth and nose. This multi-modal intervention is developed to promote improvements in the performance of protective behaviors that will reduce the spread of pathogens for ARI/ILI and GI infections by minimizing exposure from these two common pathways.
Identical weekly surveys will be administered to the intervention and control groups to measure self-reported illness, absenteeism and presenteeism; related behavior and attitudinal beliefs will be included in the surveys at specified longer intervals during the study. A sub-analysis will be performed to determine if those at high-risk for complications resulting in severe morbidity and mortality from infections show a reduction in self-reported infections, absenteeism and presenteeism. The intervention and control groups were randomized by work floors before the onset of the enrollment period.
It is hypothesized that employees in the intervention group will experience reduced self-reported illness, absenteeism and presenteeism along with improved protective hygiene behaviors, and attitudinal beliefs relative to those in the control group over the 90-day trial. Statistical analysis will be performed to determine if a relative reduction in self-reported communicable infections, absenteeism, and presenteeism, along with the improvement of related behaviors and attitudinal beliefs occurred among members in the intervention group relative to the control group over the 90-day trial. Statistical analysis will include the use of multiple imputation to impute missing variables, and the calculation of incidence rate ratios with 95% confidence intervals. Incident rate ratios will be calculated using generalized linear mixed models with a Poisson distribution and a log link function that will be adjusted for potential confounders and intercluster correlation.
- Being tested
- Multimodal hygiene intervention
- Keywords
- multi-modal intervention;, office-based employees, hand hygiene, hand sanitizer, hand sanitizer surface wipes, self-reported infections, absenteeism, presenteeism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal hygiene interventionBehavioural
hygiene supplies including hand sanitizer, hand sanitizer surface disinfectant wipes and tissues, along with the following educational materials: a 2-minute electronic educational video; weekly 30-second electronic videos; and an educational flyer.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal hygiene intervention | Experimental | Employees will receive hygiene supplies including hand sanitizer, hand sanitizer surface disinfectant wipes and tissues, along with the following educational materials: a 2-minute electronic educational video; weekly 30-second electronic videos; and an educational flyer. Training materials discuss the importance of performing hygiene behaviors to prevent the spread of pathogens, such as, cleaning hands, using tissues to cover one's mouth and nose when coughing or sneezing, and keeping office surfaces clean.
In addition, hygiene materials will be placed in common areas frequented by employees in the intervention group that include, educational hygiene posters, free standing hand sanitizer delivery stands, and bottles of hand sanitizer . Receives: Behavioral: Multimodal hygiene intervention |
| Control | No intervention | Employees will complete all surveys but will not have access to additional hygiene products. Will follow usual hygiene behaviors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in ARI/ILI/GI infections as Self-Reported in Questionnaire
The content in this measurement item has demonstrated acceptable validity and reliability in a previous study from a scale that does not have a formal title, utilized by Stedman-Smith, DuBois and Grey (2012). The scale measures whether or not participants have had self-reported (1) acute respiratory tract / influenza-like infections (ARI/ILI) or (2) gastrointestinal (GI) infections with definitions used from the Centers for Disease Control and Prevention (CDC). Measurements will occur baseline, and once per week for 12 successive weeks until the end of the trial. The number of all self-reported infections during the 3-month trial will be counted, combined and summed in the intervention and the control groups; each sum will be used to compute incidence rates and an incidence rate ratio with a 95% confidence interval (CI).
Measured: Approximately 90 days
Reduction in Absenteeism as Self-Reported in Questionnaire
Survey measurements will occur at baseline, and once per week for 12 successive weeks until the end of the trial. The content in this measurement item has demonstrated acceptable validity and reliability in a previous study from a scale that does not have a formal title, utilized by Stedman-Smith, DuBois and Grey (2012). The item contains a 6-point scale from zero days lost (0) to more than 5 days lost (6). The question was slightly adapted to add the response option of missing ½ day of work. The total number of lost work-days will be counted and summed from the 12 weekly surveys in the intervention and control group. Incidence rates and an incidence rate ratio with a 95% confidence interval will be calculated. Person days observed for this measurement will exclude holidays and weekends to match the intent of the survey regarding missed scheduled work-days.
Measured: Approximately 90 days
Reduction in Presenteeism as Self-Reported in Questionnaire
Survey measurements will occur at baseline and once per week for 12 successive weeks until the end of the trial. This measurement is based upon 3 items on the Stanford Presenteeism Scale (SPS). Each of the 3 items are measured on a scale of 1-5 points from strongly agree (1 point) to strongly disagree (5 points). The original SPS construct measured these same items from a scale of strongly disagree to strongly agree; we have modified this in order to be consistent with the order of the rest of the questions in our survey, which range from positive to negative responses. The higher the number of points, the greater the degree of presenteeism (symptoms of illness while working). The mean score for presenteeism will be calculated in the intervention and control groups; the mean differences in the two groups will be compared, along with a 95% CI.
Measured: Approximately 90 days
Secondary outcomes (3)
Reduction in ARI/ILI/GI Infections among those at Highest Risk for Complications as Self-Reported in Questionnaire
Analysis will be performed on a sub-set of employees who respond affirmatively to a question, which inquires if participants have been diagnosed with one or more listed chronic conditions. The conditions increase the risk of complications from ARI/ILI or GI infections. The content in the measurement item to assess the number of ARI/ILI/GI infections has demonstrated acceptable validity and reliability in a previous study from a scale that does not have a formal title, utilized by Stedman-Smith, DuBois and Grey (2012). The scale measures whether or not participants have had self-reported (1) ARI/ILI or (2) GI infections using definitions from the CDC. Survey measurements will occur at baseline and weekly for 12 weeks. The number of self-reported infections during the 3-month trial will be counted, combined, and summed in the intervention and control groups; incidence rates and an incident rate ratio will be calculated with a 95% CI.
Measured: Approximately 90 days
Improvement in Hygiene Behaviors as Self-Reported in Questionnaire
Survey items will be measured at the baseline; middle and conclusion of the study. Improvement in self-reported hand hygiene behaviors will be measured by a construct of seven items; the construct was part of a survey that does not have a formal title, which demonstrated acceptable validity and reliability from previous research by Stedman-Smith et al. (2012). The items contain a scale of 5 rankings from always (1) to never (5). Higher scores indicate more protective practices. Improvement in the use of hand sanitizer disinfectant wipes will be measured by a newly created item that measures the self-reported frequency of usage on a scale of 0-5, ranging from 2 or more times a day (5) to never (0). Higher scores indicate more protective self-reported hygiene practices. Mean scores will be calculated in the intervention group and in the control group and the two groups will be compared by mean differences.
Measured: Approximately 90 days
Improvement in Hygiene-Related Attitudinal Beliefs as Self-Reported in Questionnaire
Measurement will occur at the baseline; middle and end of the study. Survey items measure constructs on a scale of 1-5 from strongly agree to strongly disagree: perceived beliefs about the benefits of performing protective hygiene behaviors; perceived employer and co-worker norms about hygiene behaviors; and perceived control beliefs about performing hygiene behaviors. Higher scores indicate stronger positive beliefs. Six of the nine constructs have demonstrated acceptable validity and reliability in a survey that does not have a formal title, created by Stedman-Smith et al. (2012). Three items were created regarding the use of disinfectant surface wipes and perceptions about environmental cleanliness. All survey items consist of a scale from 1-5, ranging from strongly agree (1) to strongly disagree (5). Higher scores indicate more positive beliefs. Mean scores will be calculated in the intervention and control groups, and mean differences will be compared.
Measured: Approximately 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start5 Feb 2018
- Primary completion11 May 2018
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory InfectionStudies 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
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Collaborators
- The Golub Corporation, Price Chopper / Market 32, Cascades Tissue Group
- Responsible party
- Principal investigator, Maggie Stedman-Smith, Kent State University
- Investigators
- Maggie Stedman-Smith, Ph.D., Principal investigator, Kent State University, College of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454009
- Sponsor's protocol ID
- 18-052
- Status last verified
- Apr 2019
- First submitted
- 22 Feb 2018
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The findings from the study will be published. The publication (s) will contain author contact information. Upon written request sent to the study PI, de-identified data that specifically pertains to the results that have been published will be shared through email. De-identified data that specifically pertains to the published results will be shared by email upon written request.
Publications
Molinari NA, Ortega-Sanchez IR, Messonnier ML, Thompson WW, Wortley PM, Weintraub E, Bridges CB. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine. 2007 Jun 28;25(27):5086-96. doi: 10.1016/j.vaccine.2007.03.046. Epub 2007 Apr 20.
PubMed 17544181Fendrick AM, Monto AS, Nightengale B, Sarnes M. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Intern Med. 2003 Feb 24;163(4):487-94. doi: 10.1001/archinte.163.4.487.
PubMed 12588210Baicker K, Cutler D, Song Z. Workplace wellness programs can generate savings. Health Aff (Millwood). 2010 Feb;29(2):304-11. doi: 10.1377/hlthaff.2009.0626. Epub 2010 Jan 14.
PubMed 20075081Boyce JM, Pittet D; Healthcare Infection Control Practices Advisory Committee. Society for Healthcare Epidemiology of America. Association for Professionals in Infection Control. Infectious Diseases Society of America. Hand Hygiene Task Force. Guideline for Hand Hygiene in Health-Care Settings: recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Infect Control Hosp Epidemiol. 2002 Dec;23(12 Suppl):S3-40. doi: 10.1086/503164.
PubMed 12515399World Health Organization Writing Group; Bell D, Nicoll A, Fukuda K, Horby P, Monto A, Hayden F, Wylks C, Sanders L, van Tam J. Non-pharmaceutical interventions for pandemic influenza, national and community measures. Emerg Infect Dis. 2006 Jan;12(1):88-94. doi: 10.3201/eid1201.051371.
PubMed 16494723Centers for Disease Control and Prevention. Key facts about seasonal flu vaccine. Updated October 30, 2017: https://www.cdc.gov/flu/protect/keyfacts
Aiello AE, Coulborn RM, Perez V, Larson EL. Effect of hand hygiene on infectious disease risk in the community setting: a meta-analysis. Am J Public Health. 2008 Aug;98(8):1372-81. doi: 10.2105/AJPH.2007.124610. Epub 2008 Jun 12.
PubMed 18556606Hubner NO, Hubner C, Wodny M, Kampf G, Kramer A. Effectiveness of alcohol-based hand disinfectants in a public administration: impact on health and work performance related to acute respiratory symptoms and diarrhoea. BMC Infect Dis. 2010 Aug 24;10:250. doi: 10.1186/1471-2334-10-250.
PubMed 20735818Savolainen-Kopra C, Haapakoski J, Peltola PA, Ziegler T, Korpela T, Anttila P, Amiryousefi A, Huovinen P, Huvinen M, Noronen H, Riikkala P, Roivainen M, Ruutu P, Teirila J, Vartiainen E, Hovi T. Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial. Trials. 2012 Jan 16;13:10. doi: 10.1186/1745-6215-13-10.
PubMed 22243622Stedman-Smith M, DuBois CL, Grey SF, Kingsbury DM, Shakya S, Scofield J, Slenkovich K. Outcomes of a pilot hand hygiene randomized cluster trial to reduce communicable infections among US office-based employees. J Occup Environ Med. 2015 Apr;57(4):374-80. doi: 10.1097/JOM.0000000000000421.
PubMed 25719534Arbogast JW, Moore-Schiltz L, Jarvis WR, Harpster-Hagen A, Hughes J, Parker A. Impact of a Comprehensive Workplace Hand Hygiene Program on Employer Health Care Insurance Claims and Costs, Absenteeism, and Employee Perceptions and Practices. J Occup Environ Med. 2016 Jun;58(6):e231-40. doi: 10.1097/JOM.0000000000000738.
PubMed 27281645Centers for Disease Control and Prevention. How flu spreads. Updated October 5, 2017: https://www.cdc.gov/flu/about/index.html
Stedman-Smith M, DuBois CL, Grey SF. Hand hygiene performance and beliefs among public university employees. J Health Psychol. 2015 Oct;20(10):1263-74. doi: 10.1177/1359105313510338. Epub 2013 Nov 20.
PubMed 24265297
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kent State University / Price Chopper Wellness Promotion Study
- ClinicalTrials.gov ID
- NCT03454009
- Acronym / sponsor ID
- 18-052
- Keywords
- multi-modal intervention;, office-based employees, hand hygiene, hand sanitizer, hand sanitizer surface wipes, self-reported infections, absenteeism, presenteeism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Collaborators
- The Golub Corporation, Price Chopper / Market 32, Cascades Tissue Group
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 5 Mar 2018 (actual)
- 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.
This is a comprehensive randomized cluster hand-hygiene improvement intervention to reduce: self-reported acute respiratory tract infections (ARI) / influenza-like-illness (ILI) and gastrointestinal (GI) illness, absenteeism, presenteeism; and related behavioral and attitudinal change over a 90 day trial. The Intervention group will receive hand hygiene supplies, and a variety of educational materials, including environmental posters in common areas. The control group will perform their usual hygiene activities and will not receive an intervention.
Identical weekly surveys will be administered to the intervention and control groups to measure self-reported illness, absenteeism, presenteeism, along with behavior and attitudes measured at specified intervals during the study. The intervention and control groups were randomized by work floors before the onset of the enrollment period. It is hypothesized that employees in the intervention group will experience reduced self-reported illness, absenteeism and presenteeism along with improved protective hygiene behaviors and related attitudes, relative to those in the control group over the 90-day trial.
Detailed description
The annual costs of seasonal influenza in the United States have been estimated at $87.1 billion, while costs from the common cold have been estimated at $40 billion. Office employees are at increased risk for contracting communicable disease at work, since they spend nearly half of their waking hours in this setting, work in close proximity with each other, and share equipment. Furthermore, employers in the U.S. have a compelling interest to reduce the spread of infectious disease, because they pay for the direct and indirect costs of absenteeism in employee wages, replacement of staff, reduced quality of services, rising health care premiums, and if self-insured, direct health care expenditures.
Hand hygiene is the single most important action to reduce the transmission of pathogens that result in healthcare acquired infections. Moreover, hand hygiene and respiratory etiquette have been recommended as primary non-pharmaceutical strategies in the early stages of an epidemic before a suitable vaccine is available. While influenza vaccine uptake is the most important recommendation to prevent influenza, the vaccine only protects against 3 or 4 of the most prevalent circulating strains in a given flu season and does not provide protection against non-influenza viral and bacterial pathogens. Meta-analysis has shown that numerous community intervention studies in schools, daycare, and private homes have reduced illness from infectious disease by 21-31%.
Despite the enormous burdens from communicable disease and the importance of the workplace as a setting for the potential spread of infections, to date, only four randomized control trials have been performed world-wide among office-based employees to assess the efficacy of hand hygiene interventions to reduce the spread of communicable disease, including acute respiratory infections (ARI), influenza-like illness (ILI) and gastrointestinal infections. Collectively, these interventions have shown promising results. Hubner and colleagues (2010) found a 65% reduction in the odds of contracting the common cold among workers with improved hand hygiene in a public administrative setting in Germany while Savolainen-Kopra and colleagues (2012) found a reduction in infectious illness among office employees in Finland who participated in a study arm that utilized soap and water and educational training. In the U.S., Stedman-Smith and colleagues (2015) found a 31% significant reduction in self-reported ARI / ILI and gastrointestinal illness combined in a multi-modal hand hygiene pilot randomized cluster trial among office employees at a Midwestern government center. While, Arbogast and colleagues (2016) found a significant reduction in health care claims for communicable infections spread by hand-to-mouth modes of transmissions over a 13-month, multi-component hand hygiene trial which utilized education, hand sanitizer and disinfectant wipes.
This is a comprehensive non-pharmaceutical randomized cluster hygiene improvement intervention to reduce self-reported acute respiratory tract infections (ARIs) / influenza-like-illness (ILI) and gastrointestinal (GI) illness, absenteeism, and presenteeism over a 90-day trial. The Intervention group will receive hygiene supplies (hand sanitizer, surface disinfectant wipes, tissues) and educational materials in varied mediums, including brief educational videos, and motivational posters hung in common work areas, in addition to hand sanitizer, along with hand sanitizer and surface disinfectant wipes installed in shared work areas. The control group will perform their usual hygiene activities and will not receive an intervention. Predominate pathways for the spread of ARI/ILI and non-foodborne GI infections include: (1) droplets that land on the nose, mouth, or are inhaled from infected persons' who cough, sneeze or talk; or (2) pathogens on hands contaminated from fomites or from touching infected persons, which come in contact with portals of entry including the mouth and nose. This multi-modal intervention is developed to promote improvements in the performance of protective behaviors that will reduce the spread of pathogens for ARI/ILI and GI infections by minimizing exposure from these two common pathways.
Identical weekly surveys will be administered to the intervention and control groups to measure self-reported illness, absenteeism and presenteeism; related behavior and attitudinal beliefs will be included in the surveys at specified longer intervals during the study. A sub-analysis will be performed to determine if those at high-risk for complications resulting in severe morbidity and mortality from infections show a reduction in self-reported infections, absenteeism and presenteeism. The intervention and control groups were randomized by work floors before the onset of the enrollment period.
It is hypothesized that employees in the intervention group will experience reduced self-reported illness, absenteeism and presenteeism along with improved protective hygiene behaviors, and attitudinal beliefs relative to those in the control group over the 90-day trial. Statistical analysis will be performed to determine if a relative reduction in self-reported communicable infections, absenteeism, and presenteeism, along with the improvement of related behaviors and attitudinal beliefs occurred among members in the intervention group relative to the control group over the 90-day trial. Statistical analysis will include the use of multiple imputation to impute missing variables, and the calculation of incidence rate ratios with 95% confidence intervals. Incident rate ratios will be calculated using generalized linear mixed models with a Poisson distribution and a log link function that will be adjusted for potential confounders and intercluster correlation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal hygiene intervention | Experimental | Behavioral: Multimodal hygiene interventionEmployees will receive hygiene supplies including hand sanitizer, hand sanitizer surface disinfectant wipes and tissues, along with the following educational materials: a 2-minute electronic educational video; weekly 30-second electronic videos; and an educational flyer. Training materials discuss the importance of performing hygiene behaviors to prevent the spread of pathogens, such as, cleaning hands, using tissues to cover one's mouth and nose when coughing or sneezing, and keeping office surfaces clean. In addition, hygiene materials will be placed in common areas frequented by employees in the intervention group that include, educational hygiene posters, free standing hand sanitizer delivery stands, and bottles of hand sanitizer . |
| Control | No intervention | –Employees will complete all surveys but will not have access to additional hygiene products. Will follow usual hygiene behaviors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years or older
- No known allergies to alcohol or surface disinfecting wipes;
- Works at least 30% of office hours at the study host site;
- Consent to receiving emails from Kent State University.
Key exclusion criteria (4 listed)
- Under 18 years of age;
- Known allergies to alcohol or surface disinfecting wipes;
- Works less than 30% of office hours at the study host site;
- Does not consent to receiving emails from Kent State University.
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 |
|---|---|---|
| Multimodal hygiene interventionhygiene supplies including hand sanitizer, hand sanitizer surface disinfectant wipes and tissues, along with the following educational materials: a 2-minute electronic educational video; weekly 30-second electronic videos; and an educational flyer. | Behavioural | Multimodal hygiene intervention |
Primary outcome
Reduction in ARI/ILI/GI infections as Self-Reported in Questionnaire
Time frame: Approximately 90 days
The content in this measurement item has demonstrated acceptable validity and reliability in a previous study from a scale that does not have a formal title, utilized by Stedman-Smith, DuBois and Grey (2012). The scale measures whether or not participants have had self-reported (1) acute respiratory tract / influenza-like infections (ARI/ILI) or (2) gastrointestinal (GI) infections with definitions used from the Centers for Disease Control and Prevention (CDC). Measurements will occur baseline, and once per week for 12 successive weeks until the end of the trial. The number of all self-reported infections during the 3-month trial will be counted, combined and summed in the intervention and the control groups; each sum will be used to compute incidence rates and an incidence rate ratio with a 95% confidence interval (CI).
Reduction in Absenteeism as Self-Reported in Questionnaire
Time frame: Approximately 90 days
Survey measurements will occur at baseline, and once per week for 12 successive weeks until the end of the trial. The content in this measurement item has demonstrated acceptable validity and reliability in a previous study from a scale that does not have a formal title, utilized by Stedman-Smith, DuBois and Grey (2012). The item contains a 6-point scale from zero days lost (0) to more than 5 days lost (6). The question was slightly adapted to add the response option of missing ½ day of work. The total number of lost work-days will be counted and summed from the 12 weekly surveys in the intervention and control group. Incidence rates and an incidence rate ratio with a 95% confidence interval will be calculated. Person days observed for this measurement will exclude holidays and weekends to match the intent of the survey regarding missed scheduled work-days.
Reduction in Presenteeism as Self-Reported in Questionnaire
Time frame: Approximately 90 days
Survey measurements will occur at baseline and once per week for 12 successive weeks until the end of the trial. This measurement is based upon 3 items on the Stanford Presenteeism Scale (SPS). Each of the 3 items are measured on a scale of 1-5 points from strongly agree (1 point) to strongly disagree (5 points). The original SPS construct measured these same items from a scale of strongly disagree to strongly agree; we have modified this in order to be consistent with the order of the rest of the questions in our survey, which range from positive to negative responses. The higher the number of points, the greater the degree of presenteeism (symptoms of illness while working). The mean score for presenteeism will be calculated in the intervention and control groups; the mean differences in the two groups will be compared, along with a 95% CI.
3 secondary outcomes
Reduction in ARI/ILI/GI Infections among those at Highest Risk for Complications as Self-Reported in Questionnaire
Time frame: Approximately 90 days
Improvement in Hygiene Behaviors as Self-Reported in Questionnaire
Time frame: Approximately 90 days
Improvement in Hygiene-Related Attitudinal Beliefs as Self-Reported in Questionnaire
Time frame: Approximately 90 days
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 1 May 2019.
- Background: PubMed 17544181Molinari NA, Ortega-Sanchez IR, Messonnier ML, Thompson WW, Wortley PM, Weintraub E, Bridges CB. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine. 2007 Jun 28;25(27):5086-96. doi: 10.1016/j.vaccine.2007.03.046. Epub 2007 Apr 20.
- Background: PubMed 12588210Fendrick AM, Monto AS, Nightengale B, Sarnes M. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Intern Med. 2003 Feb 24;163(4):487-94. doi: 10.1001/archinte.163.4.487.
- Background: PubMed 20075081Baicker K, Cutler D, Song Z. Workplace wellness programs can generate savings. Health Aff (Millwood). 2010 Feb;29(2):304-11. doi: 10.1377/hlthaff.2009.0626. Epub 2010 Jan 14.
- Background: PubMed 12515399Boyce JM, Pittet D; Healthcare Infection Control Practices Advisory Committee. Society for Healthcare Epidemiology of America. Association for Professionals in Infection Control. Infectious Diseases Society of America. Hand Hygiene Task Force. Guideline for Hand Hygiene in Health-Care Settings: recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Infect Control Hosp Epidemiol. 2002 Dec;23(12 Suppl):S3-40. doi: 10.1086/503164.
- Background: PubMed 16494723World Health Organization Writing Group; Bell D, Nicoll A, Fukuda K, Horby P, Monto A, Hayden F, Wylks C, Sanders L, van Tam J. Non-pharmaceutical interventions for pandemic influenza, national and community measures. Emerg Infect Dis. 2006 Jan;12(1):88-94. doi: 10.3201/eid1201.051371.
- BackgroundCenters for Disease Control and Prevention. Key facts about seasonal flu vaccine. Updated October 30, 2017: https://www.cdc.gov/flu/protect/keyfacts
- Background: PubMed 18556606Aiello AE, Coulborn RM, Perez V, Larson EL. Effect of hand hygiene on infectious disease risk in the community setting: a meta-analysis. Am J Public Health. 2008 Aug;98(8):1372-81. doi: 10.2105/AJPH.2007.124610. Epub 2008 Jun 12.
- Background: PubMed 20735818Hubner NO, Hubner C, Wodny M, Kampf G, Kramer A. Effectiveness of alcohol-based hand disinfectants in a public administration: impact on health and work performance related to acute respiratory symptoms and diarrhoea. BMC Infect Dis. 2010 Aug 24;10:250. doi: 10.1186/1471-2334-10-250.
- Background: PubMed 22243622Savolainen-Kopra C, Haapakoski J, Peltola PA, Ziegler T, Korpela T, Anttila P, Amiryousefi A, Huovinen P, Huvinen M, Noronen H, Riikkala P, Roivainen M, Ruutu P, Teirila J, Vartiainen E, Hovi T. Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial. Trials. 2012 Jan 16;13:10. doi: 10.1186/1745-6215-13-10.
- Background: PubMed 25719534Stedman-Smith M, DuBois CL, Grey SF, Kingsbury DM, Shakya S, Scofield J, Slenkovich K. Outcomes of a pilot hand hygiene randomized cluster trial to reduce communicable infections among US office-based employees. J Occup Environ Med. 2015 Apr;57(4):374-80. doi: 10.1097/JOM.0000000000000421.
- Background: PubMed 27281645Arbogast JW, Moore-Schiltz L, Jarvis WR, Harpster-Hagen A, Hughes J, Parker A. Impact of a Comprehensive Workplace Hand Hygiene Program on Employer Health Care Insurance Claims and Costs, Absenteeism, and Employee Perceptions and Practices. J Occup Environ Med. 2016 Jun;58(6):e231-40. doi: 10.1097/JOM.0000000000000738.
- BackgroundCenters for Disease Control and Prevention. How flu spreads. Updated October 5, 2017: https://www.cdc.gov/flu/about/index.html
- Individual participant dataSharing planned: Yes. The findings from the study will be published. The publication (s) will contain author contact information. Upon written request sent to the study PI, de-identified data that specifically pertains to the results that have been published will be shared through email. De-identified data that specifically pertains to the published results will be shared by email upon written request.
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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. principal investigator
Kent State University, College of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal hygiene intervention in people with Acute Respiratory Infection and Influenza-like Illness, 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 4 inclusion and 4 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 1 May 2019. 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. 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?
Reduction in ARI/ILI/GI infections as Self-Reported in Questionnaire (time frame: Approximately 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03454009, which also lists 13 linked publications.
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 1 May 2019.