REDI-US Study
The REDI-US Study is being conducted by the UC Berkeley Center for Infectious Disease & Emergency Readiness and is supported by a cooperative agreement from the Centers for Disease Control and Prevention.
REDI-US Study Participants:
The REDI-US Study is now closed. We would like to thank all of our participants for their time in completing weekly surveys for the REDI-US Study! We have truly appreciated your participation.
Final thank you gifts have been mailed to all participants. Those participants who completed all 25 surveys received an additional $10 worth of their chosen gift (i.e., Starbucks Cards, Napster music downloads, or Amazon.com gift cards).
Participants' names were entered into a long-odds or short-odds raffle drawing each time a REDI-US Study survey was completed. Raffle winners have been randomly selected and notified. Congratulations to our one long-odds winner of a $500 Visa gift card, and our 10 short-odds winners of $50 Visa gift cards!
REDI-US Study Informed Consent document
Please do not hesitate to contact us if you have any questions about your participation in this study.
E-mail: redi-us@berkeley.edu
Phone: 510.643.4921
REDI-US Study Update
General Study Overview
Objectives
The primary objective of the REDI-US (Reducing Influenza-like Illness among University Students) Study was to determine whether providing education about respiratory and hand hygiene reduced the occurrence of influenza-like illness.
Specifically, the objective of the REDI-US Study was to assess the effectiveness of select non-pharmaceutical interventions (NPIs) in reducing the occurrence of influenza-like illness among students at the University of California, Berkeley. Non-pharmaceutical interventions are non-drug or non-vaccine based ways to prevent influenza. The interventions of interest in the REDI-US Study included hand and respiratory hygiene, cough etiquette, and mask use.
A secondary objective was to evaluate whether influenza-like illness is predictive of influenza in this population.
Study Period
The REDI-US Study was conducted between 2006 and 2008. A Year 1 pilot study was conducted from March to April 2007. The full study was conducted in Year 2, from October 2007 to May 2008. Participants in the Year 1 pilot study were not eligible to participate in the Year 2 full study.
Study Design
The REDI-US Study was a randomized controlled trial in which participants were randomized to an educational intervention or a non-intervention group. As described in the informed consent document, students “may be provided information on measures you can take to prevent contracting and/or transmitting respiratory infections. These measures are part of standard practice in the prevention of infectious respiratory diseases.” The information provided in the REDI-US Study intervention was readily and publicly available to non-intervention participants through other existing websites and public health messaging; non-intervention group participants were not prevented from accessing this information through other sources.
The intervention group was provided with education about respiratory and hand hygiene, cough etiquette, and mask use. The intervention was delivered via a secure on-line website (www.flu-u.com) and through provision of materials necessary for adherence to recommended behaviors (e.g., hand sanitizer, masks, tissues).
Year 1 results indicated that questions about hand and respiratory hygiene behaviors on the survey itself might have influenced these behaviors in the non-intervention group. Therefore, the Year 2 non-intervention group was split into two: half of the non-intervention participants received the full weekly survey with questions about their behaviors (“non-intervention full” group), while half received a shorter survey that did not include questions related to behaviors (“non-intervention short” group).
Participation
Year 1: 880 students participated in the Year 1 pilot study. Year 1 data collection included a baseline survey, 7 weekly surveys, and an end of study survey. More than 78% of participants completed the surveys each week.
Year 2: 2,300 students participated in Year 2 of the study. Year 2 data collection included a baseline survey, 23 weekly surveys, and an end of study survey, with completion rates consistently higher than 76%.
Demographics collected in the baseline surveys indicated that study participants were representative of the student population at UCB in both Years 1 and 2.
Additional results will be published as the data is analyzed.
Significance
The results of this study will provide important information on the effectiveness and cost-effectiveness of respiratory and hand hygiene, cough etiquette, and mask use for seasonal and pandemic flu, in particular among university students. Additionally, the findings will address the acceptability of an online intervention for cold and flu prevention among university students. Finally, the infrastructure developed for this study will support and inform pandemic preparedness planning for students at the University of California, Berkeley, and other universities across the nation.
Frequently Asked Questions
Recruitment & Enrollment
How many people were recruited for the study?
In Year 1, approximately 6,000 students at UC Berkeley were recruited for participation in the REDI-US Study. In Year 2, approximately 15,000 students were recruited for participation.
How were students selected for recruitment?
Students were randomly selected from a list of all students registered at least half-time at UC Berkeley during the recruitment semester. In Year 1, this was the Spring 2007 semester. In Year 2, this was the Fall 2007 semester.
How were students recruited?
Three emails and a paper mailing were sent to the randomly selected students at the address the University had on file for them. Interested students were directed to a web page to read the informed consent document and enroll in the study online.
How many people enrolled in the study?
880 students enrolled in Year 1 of the REDI-US Study, which ran from March 5, 2007 until April 24, 2007. 2,300 students enrolled in Year 2 of the REDI-US Study, which ran from October 15, 2007 until April 21, 2008.
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Study Design
What is a randomized controlled trial?
A randomized controlled trial is one in which participants are randomly allocated to receive an intervention/treatment or to not receive an intervention/treatment. Sometimes the group that does not receive the intervention/treatment is referred to as a “control group” or a “placebo group.”
The informed consent document for the REDI-US Study stated: “You may be provided information on measures you can take to prevent contracting and/or transmitting respiratory infections. These measures are part of standard practice in the prevention of infectious respiratory diseases.” This indicated that it was possible that participants may receive the intervention in question.
Why is a randomized design used?
Randomization helps prevent extraneous factors, or those that are not being evaluated in the study, from biasing the study results. For example, students with "healthy" behaviors may have been more likely to enroll in the REDI-US study. However, since all participants were randomly assigned to either the educational intervention or non-intervention group, such baseline behaviors should be roughly equal across the two groups and should not bias the study results.
Why are individuals "blinded" to which group they are in?
In a randomized controlled trial, participants usually remain unaware of, or are "blinded" to, which intervention/treatment they have received until the study is complete. This helps to prevent participants' views of the intervention/treatment from biasing the assessment of the intervention.
How many people were randomized to the intervention and non-intervention groups?
In Year 1, 440 students were randomly allocated to the intervention group, and 440 students were randomly allocated to the non-intervention group.
In Year 2, 1,150 students were randomly allocated to the intervention group, and 1,150 students were randomly allocated to the non-intervention group. The non-intervention group was then randomized into two parts:.
575 students were randomized to a "non-intervention full" group
575 students were randomized to a "non-intervention short" group
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The Intervention and Non-Intervention Groups
What did the intervention involve?
Participants who were randomly allocated to the intervention group received access to education from the REDI-US Study about non-pharmaceutical (non-drug or non-vaccine based) ways to protect themselves from respiratory illnesses such as cold and flu. The education was provided via a secure website called Flu-U www.flu-u.com. This educational information discussed hand hygiene (e.g., hand washing and the use of alcohol-based hand sanitizers), cough etiquette (covering coughs with sleeves or tissues, and practicing hand hygiene afterward), and mask use.
In addition, participants in the intervention group were provided with a kit that contained materials necessary to adhere to the hand and respiratory hygiene and cough etiquette recommendations. This kit included hand sanitizer, face masks, tissues, a digital thermometer, and a study information card with educational information.
What was on the Flu-U website?
The Flu-U website www.flu-u.com was designed for the intervention group to provide online education about hand and respiratory hygiene, cough etiquette, and mask use. The website included videos, weekly quizzes, and news updates.
Who can access Flu-U?
Flu-U was only available for intervention group participants during the REDI-US Study. Flu-U is now available for viewing by the general public. No username or password is required to access the site. If you are interested in viewing the Flu-U site, please visit www.flu-u.com.
What was participation like for those in the non-intervention groups?
Students who were randomly selected to be in the non-intervention groups did not receive access to education from the REDI-US Study about non-pharmaceutical (non-drug or non-vaccine based) ways to protect themselves from respiratory illnesses such as cold and flu. The information provided in the REDI-US Study intervention was readily and publicly available to non-intervention participants through other existing websites and public health messaging; non-intervention group participants were not prevented from accessing this information through other sources.
Non-intervention group participants also received a REDI-US Study bag that contained a digital thermometer and a study information card.
What was the difference between the "non-intervention full" and "non-intervention short" groups?
In Year 2, the non-intervention group was split into two: the “non-intervention full” and “non-intervention short” groups. The difference in these two groups was the length of their weekly surveys. The “non-intervention short” group received shorter surveys that did not include repeated questions about typical health behaviors.
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Data Collection, Analysis, and Results
How were data collected?
Data were collected in three different ways. First, participants provided data via on-line surveys every week. Second, participants submitting symptoms consistent with the CDC case definition for influenza-like illness (fever > 100 degrees Fahrenheit AND cough and/or sore throat) were invited to receive a test for influenza. Finally, a small sample of students was randomly selected and invited to participate in focus groups after the surveys ended in Year 2.
What is influenza-like illness?
The Centers for Disease Control and Prevention (CDC) defines influenza-like illness as fever > 100 degrees Fahrenheit AND cough and/or sore throat. Several different viruses, including the influenza virus, can cause influenza-like illness.
Why were focus groups held?
Focus groups were held to gather more in-depth feedback on individuals’ experiences with the REDI-US Study. Focus groups were held with three distinct groups: students recruited for Year 2 of the study that did not enroll in the study (non-participants); Year 2 participants that were randomly allocated to the intervention group; and, Year 2 participants that were randomly allocated to the “non-intervention full” group.
How will data be analyzed?
A mixture of quantitative and qualitative analysis will be used to examine the data provided by REDI-US Study (on-line surveys and influenza testing) and REDI-US Study Evaluation (focus group) participants.
What results are available at this time?
Data collected in both Years 1 and 2 are currently being analyzed. The following descriptive results are available:
880 participants participated in Year 1 of the study; 2,300 participated in Year 2.
Year 1 data collection included a baseline survey, 7 weekly surveys, and an end of study survey. More than 78% of participants completed the surveys each week.
Year 2 data collection included a baseline survey, 23 weekly surveys, and an end of study survey, with completion rates consistently higher than 76%.
Demographics collected in both of the baseline surveys indicated that study participants were representative of the student population at UCB in both Years 1 and 2.
Additional results will be published as the data is analyzed.
When will more results be available?
Results will be posted on this website as they become available. Please check back for updates, or sign up for the listserv to be informed when results are added. To sign up for the listserv, please click here.
Results will be published in peer-reviewed journals. Information about these publications will be posted here as they are available.
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Study Contributions
Why does this study matter?
During the early stages of an influenza pandemic, there will be limited or no vaccine, and antivirals will be in short supply. Non-pharmaceutical interventions (non-drug or non-vaccine based interventions) may be the only available strategy to reduce transmission of pandemic influenza. However, at this time we do not know the effectiveness of these strategies in reducing the transmission of influenza among individuals and the community.
The REDI-US Study was designed to address questions regarding hand and respiratory hygiene, cough etiquette, and mask use, specifically among university students. This is important because students may have unique barriers to adherence to these behaviors, and require tailored education and information to increase compliance. The diversity of backgrounds and cultures together on one campus may also mean that certain strategies are not equally acceptable to all students on campus.
Did my participation help?
YES! The contribution of each participant in Years 1 and 2 of the REDI-US Study and the REDI-US Study Evaluation was critical to achieve the specific aims of the research.
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Future Updates
How do I find out about future updates?
Future updates will be posted to this website as they become available. If you would like to be notified when updates have been posted, please subscribe to the REDI-US listserv by clicking here.
Who do I contact if I have other questions?
If you have additional questions about the REDI-US Study, please email the REDI-US Study at redi-us@berkeley.edu, or call 510.643.4921.
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Modified by EC: 2008-5-23; 3:54pm