- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00142077
Electronic Health Records for Health Promotion
April 4, 2007 updated by: Boston Children's Hospital
Health Promotion in the Workplace Using Personally Controlled Health Records
The purpose of this study is to determine whether personally controlled electronic health records can be used for health promotion in a workplace setting.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In response to the call for research of the new Health Protection Research Initiative at the Centers for Disease Control and Prevention (CDC), we propose to adapt newly mature informatics technology to shift the paradigm for health alerting and health promotion in the workplace.
The goal is to firmly ground these activities on real time information collected from and delivered to employees, in an interactive, secure, electronic environment.
We will study influenza prevention and control, an archetype of public health practice requiring surveillance, communication, and timely influence of health-related behaviors.
Complex information gleaned from surveillance will be processed, translated and provided to employees.
The goal is to provide employees with timely, individualized health promotion messages to improve their knowledge, attitudes and beliefs regarding influenza and to increase the rate of seasonal influenza immunization for them and their household members.
The approach will be evaluated in a group randomized design at several worksites of a major corporation.
Study Type
Interventional
Enrollment
700
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02116
- Children's Hospital Boston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The subject is a part-time or full-time employee at a major corporation.
- The subject is eighteen years of age or older.
- The subject is comfortable reading and writing in English.
- The subject has reliable internet access at home, at school, or at work.
- The subject uses email regularly (i.e. at least once every 2 days)
- The subject does not have a known allergy to chicken eggs or a history of a severe reaction to an influenza vaccination in the past.
Exclusion Criteria:
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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- Rate of influenza immunization among subjects
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Secondary Outcome Measures
Outcome Measure |
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Change in knowledge, attitutes, and beliefs regarding influenza and influenza immunization.
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Changes in health behaviors around influenza (e.g. hand washing and cough etiquette).
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General health outcomes related to respiratory illnesses (e.g. number of influenza-like illnesses, number of physician visits, number of missed work days).
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Rate of influenza immunization among subject household members.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenneth D Mandl, MD, MPH, Boston Children's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Harper SA, Fukuda K, Uyeki TM, Cox NJ, Bridges CB; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2005 Jul 29;54(RR-8):1-40. Erratum In: MMWR Morb Mortal Wkly Rep. 2005 Aug 5;54(30):750.
- Nichol KL. Cost-benefit analysis of a strategy to vaccinate healthy working adults against influenza. Arch Intern Med. 2001 Mar 12;161(5):749-59. doi: 10.1001/archinte.161.5.749.
- Keech M, Scott AJ, Ryan PJ. The impact of influenza and influenza-like illness on productivity and healthcare resource utilization in a working population. Occup Med (Lond). 1998 Feb;48(2):85-90. doi: 10.1093/occmed/48.2.85.
- Bridges CB, Thompson WW, Meltzer MI, Reeve GR, Talamonti WJ, Cox NJ, Lilac HA, Hall H, Klimov A, Fukuda K. Effectiveness and cost-benefit of influenza vaccination of healthy working adults: A randomized controlled trial. JAMA. 2000 Oct 4;284(13):1655-63. doi: 10.1001/jama.284.13.1655.
- Mandl KD, Szolovits P, Kohane IS. Public standards and patients' control: how to keep electronic medical records accessible but private. BMJ. 2001 Feb 3;322(7281):283-7. doi: 10.1136/bmj.322.7281.283. No abstract available.
- Riva A, Mandl KD, Oh DH, Nigrin DJ, Butte A, Szolovits P, Kohane IS. The personal internetworked notary and guardian. Int J Med Inform. 2001 Jun;62(1):27-40. doi: 10.1016/s1386-5056(00)00136-2.
- Mandl KD, Overhage JM, Wagner MM, Lober WB, Sebastiani P, Mostashari F, Pavlin JA, Gesteland PH, Treadwell T, Koski E, Hutwagner L, Buckeridge DL, Aller RD, Grannis S. Implementing syndromic surveillance: a practical guide informed by the early experience. J Am Med Inform Assoc. 2004 Mar-Apr;11(2):141-50. doi: 10.1197/jamia.M1356. Epub 2003 Nov 21.
- Heffernan R, Mostashari F, Das D, Karpati A, Kulldorff M, Weiss D. Syndromic surveillance in public health practice, New York City. Emerg Infect Dis. 2004 May;10(5):858-64. doi: 10.3201/eid1005.030646. Erratum In: Emerg Infect Dis. 2006 Sep;12(9):1472.
- Bourgeois FT, Simons WW, Olson K, Brownstein JS, Mandl KD. Evaluation of influenza prevention in the workplace using a personally controlled health record: randomized controlled trial. J Med Internet Res. 2008 Mar 14;10(1):e5. doi: 10.2196/jmir.984.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Study Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
August 31, 2005
First Submitted That Met QC Criteria
August 31, 2005
First Posted (Estimate)
September 2, 2005
Study Record Updates
Last Update Posted (Estimate)
April 5, 2007
Last Update Submitted That Met QC Criteria
April 4, 2007
Last Verified
January 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 R01 CDC 000065-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.