InfluenzaIndivo at MITNCT00531700
Testing a Personally Controlled Health Record to Ameliorate Influenza at MIT
A study testing Health messaging and Health messages in people with Influenza, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The purpose of this project is to evaluate the effects on influenza related knowledge, attitudes and behaviors of exposure to tailored/targeted health messages and contextualized information about influenza like illness delivered to subjects through a personally controlled health record system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Health messaging and Health messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jan 2009
- 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
- Ages 18 and over
- English speaker
- Affiliated with study site
Who cannot join
- Younger than 18
- No access to computers or the internet
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02215
About this study
Official title: Test of the PING/INDIVO Personal Health Record System at MIT
The purpose of this project is to evaluate the effects on influenza related knowledge, attitudes and behaviors of exposure to tailored/targeted health messages and contextualized information about influenza like illness delivered to subjects through a personally controlled health record system. The main study hypothesis is that exposure to more intensive levels of personalized and contextualized information about risk will result in increased knowledge about influenza, greater attributions of immunization safety and efficacy, improved health protecting behaviors including higher levels of appropriate immunization.
Read the detailed description
The goal of our work is to test an information infrastructure that creates a three-way link among individuals, health care providers and public health authorities, testing the efficacy of this system for improving the prevention and control of influenza. Our model comprises a full feedback system in which an electronic personally controlled health record (PCHR) provides a primary data source for population-based surveillance and a vehicle for delivery of health promotion messages, in this case about influenza immunization and control. This system will feed into and draw on data from a statewide real-time influenza surveillance system, and be integrated with hospital/provider data systems, forming the three-way link. The influenza pandemic is a "great global infectious disease threat" {Osterholm, 2005} for which we are ill prepared. With limited vaccine supply for the past two years and probably next year as well, it is critical to: understand who should be vaccinated to ameliorate population-wide transmission; have effective channels for delivering health directives to high risk groups; monitor efficacy. We will deploy and test our three-way link model and PCHR record system in a multisite study and evaluate using a randomized controlled design the effects on immunization rates of tailored messages about influenza immunization delivered to patients through the electronic health record. Our focus is children ages 6 months to ten years of age and their household members (two of four settings), all age groups including children and working adults (two settings), and university students/staff (one setting). The specific aims follow.
Aim 1.To leverage an electronic personally controlled health record as a public health tool, establishing three way communication systems among individuals, health systems, and public health agencies. We will establish a formal mechanism for patients to integrate and share healthcare-based and personally entered information. Individuals can share information from their medical record, and in response to surveys delivered through the system. There will be two way communications between the record and the State Immunization Registry. Particular attention will be paid to information security, compliance with the Health Insurance Portability and Accountability Act (HIPAA) privacy rule, and personal control. Primary measurements include the structural integrity of the information system, use and usability of the system, and user acceptance. The main hypothesis to be tested is that people are generally willing to share their personally controlled data to promote personal and public health.
Aim 2. To adapt a traditional syndromic surveillance system, initially designed as an early detector of outbreaks, to nimbly identify patients to be targeted for behavior change through personally controlled electronic records. We will develop health messages as cues to action, directed at improving individual compliance with influenza prevention, calibrating our detection models to identify high risk groups, based on demographic and clinical data contained in personal health records. Messages will be targeted at appropriate risk groups and contain information tailored to the individual's characteristics. The primary focus will be to encourage influenza immunization when indicated and conversely, to encourage delay in immunization under conditions of low risk and scarcity. We will change the content, tempo, and targets of the messages based on real time influenza surveillance. The main hypothesis to be tested is that a real-time surveillance system can be used to calibrate health messaging. A second hypothesis is that sentinel individuals can provide data to surveillance systems that adds value to what is already collected.
Aim 3. To measure the impact on immunization rates of tailored health messages, linked to surveillance, and delivered through a personal health record. We will evaluate the impact of directed communications delivered to randomly selected study participants through a personal health record on influenza vaccination rates comparing them to rates among control participants. Secondary outcomes will include message impacts on rates of self-reported illness, knowledge, attitudes and beliefs about influenza and immunization efficacy, use of recommended health protective behaviors. We will investigate the impacts on technology use and immunization rates of a range of individual social demographic characteristics, household characteristics, and computing-related factors that may influence the acceptability of the proposed technology and/or target health behaviors. The main hypothesis to be tested is that individuals exposed to tailored health messages delivered through a PCHR will have higher influenza immunization rates than their unexposed peers. Secondary hypotheses are that compliance will be moderated by computing experience, acceptability/accessibility, individual demographics (e.g., age, sex, race/ethnicity, social class) social and scheduling supports (e.g., work/time schedule flexibility) , family health factors, and logistical factors (transportation, ease of access to immunization sites, convenience, clear scheduling/notification and minimal waiting time for services).
- Conditions
- Influenza
- Being tested
- Health messaging, Health messages
- Keywords
- influenza, risk behaviors, immunization, knowledge attitudes behaviors, personally controlled health record, Indivo
- Medical subject headings
- Influenza, Human, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health messagingOther
Combinations of personalized health messages (tailored/targeted) and contextualized health messages (reports about localized epidemiologic risk) will be delivered to subjects
Health messagesOther
community level health messages unrelated to the study originating exposures
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Exposure to both tailored/targeted health messages about influenza and also to reports about contextualized influenza risk Receives: Other: Health messaging |
| II | Experimental | Exposure to tailored/targeted health messages Receives: Other: Health messaging |
| III | Experimental | Exposure to reports about influenza related contextualized risk Receives: Other: Health messaging |
| IV | Active comparator | Comparison group exposed to community level health promotion messages not generated by the study Receives: Other: Health messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
appropriate immunization behavior
Measured: six months
Secondary outcomes (3)
reduced presenteeism for school and work
Measured: six months
appropriate immunization behaviors for close household/family members
Measured: six months
knowledge about influenza and beliefs about influenza risk and transmission
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Elissa R Weitzman, Principal investigator, Boston Children's HospitalKenneth D Mandl, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531700
- Sponsor's protocol ID
- 06-07-0347
- Acronym
- Indivo at MIT
- Status last verified
- Apr 2009
- First submitted
- 18 Sep 2007
- Last updated
- 1 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test of the PING/INDIVO Personal Health Record System at MIT
- ClinicalTrials.gov ID
- NCT00531700
- Acronym / sponsor ID
- Indivo at MIT / 06-07-0347
- Conditions
- Influenza
- Keywords
- influenza, risk behaviors, immunization, knowledge attitudes behaviors, personally controlled health record, Indivo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Oct 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Sep 2007 (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 project is to evaluate the effects on influenza related knowledge, attitudes and behaviors of exposure to tailored/targeted health messages and contextualized information about influenza like illness delivered to subjects through a personally controlled health record system. The main study hypothesis is that exposure to more intensive levels of personalized and contextualized information about risk will result in increased knowledge about influenza, greater attributions of immunization safety and efficacy, improved health protecting behaviors including higher levels of appropriate immunization.
Detailed description
The goal of our work is to test an information infrastructure that creates a three-way link among individuals, health care providers and public health authorities, testing the efficacy of this system for improving the prevention and control of influenza. Our model comprises a full feedback system in which an electronic personally controlled health record (PCHR) provides a primary data source for population-based surveillance and a vehicle for delivery of health promotion messages, in this case about influenza immunization and control. This system will feed into and draw on data from a statewide real-time influenza surveillance system, and be integrated with hospital/provider data systems, forming the three-way link. The influenza pandemic is a "great global infectious disease threat" {Osterholm, 2005} for which we are ill prepared. With limited vaccine supply for the past two years and probably next year as well, it is critical to: understand who should be vaccinated to ameliorate population-wide transmission; have effective channels for delivering health directives to high risk groups; monitor efficacy. We will deploy and test our three-way link model and PCHR record system in a multisite study and evaluate using a randomized controlled design the effects on immunization rates of tailored messages about influenza immunization delivered to patients through the electronic health record. Our focus is children ages 6 months to ten years of age and their household members (two of four settings), all age groups including children and working adults (two settings), and university students/staff (one setting). The specific aims follow.
Aim 1.To leverage an electronic personally controlled health record as a public health tool, establishing three way communication systems among individuals, health systems, and public health agencies. We will establish a formal mechanism for patients to integrate and share healthcare-based and personally entered information. Individuals can share information from their medical record, and in response to surveys delivered through the system. There will be two way communications between the record and the State Immunization Registry. Particular attention will be paid to information security, compliance with the Health Insurance Portability and Accountability Act (HIPAA) privacy rule, and personal control. Primary measurements include the structural integrity of the information system, use and usability of the system, and user acceptance. The main hypothesis to be tested is that people are generally willing to share their personally controlled data to promote personal and public health.
Aim 2. To adapt a traditional syndromic surveillance system, initially designed as an early detector of outbreaks, to nimbly identify patients to be targeted for behavior change through personally controlled electronic records. We will develop health messages as cues to action, directed at improving individual compliance with influenza prevention, calibrating our detection models to identify high risk groups, based on demographic and clinical data contained in personal health records. Messages will be targeted at appropriate risk groups and contain information tailored to the individual's characteristics. The primary focus will be to encourage influenza immunization when indicated and conversely, to encourage delay in immunization under conditions of low risk and scarcity. We will change the content, tempo, and targets of the messages based on real time influenza surveillance. The main hypothesis to be tested is that a real-time surveillance system can be used to calibrate health messaging. A second hypothesis is that sentinel individuals can provide data to surveillance systems that adds value to what is already collected.
Aim 3. To measure the impact on immunization rates of tailored health messages, linked to surveillance, and delivered through a personal health record. We will evaluate the impact of directed communications delivered to randomly selected study participants through a personal health record on influenza vaccination rates comparing them to rates among control participants. Secondary outcomes will include message impacts on rates of self-reported illness, knowledge, attitudes and beliefs about influenza and immunization efficacy, use of recommended health protective behaviors. We will investigate the impacts on technology use and immunization rates of a range of individual social demographic characteristics, household characteristics, and computing-related factors that may influence the acceptability of the proposed technology and/or target health behaviors. The main hypothesis to be tested is that individuals exposed to tailored health messages delivered through a PCHR will have higher influenza immunization rates than their unexposed peers. Secondary hypotheses are that compliance will be moderated by computing experience, acceptability/accessibility, individual demographics (e.g., age, sex, race/ethnicity, social class) social and scheduling supports (e.g., work/time schedule flexibility) , family health factors, and logistical factors (transportation, ease of access to immunization sites, convenience, clear scheduling/notification and minimal waiting time for services).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Other: Health messagingExposure to both tailored/targeted health messages about influenza and also to reports about contextualized influenza risk |
| II | Experimental | Other: Health messagingExposure to tailored/targeted health messages |
| III | Experimental | Other: Health messagingExposure to reports about influenza related contextualized risk |
| IV | Active comparator | Other: Health messagesComparison group exposed to community level health promotion messages not generated by the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18 and over
- English speaker
- Affiliated with study site
Key exclusion criteria (2 listed)
- Younger than 18
- No access to computers or the internet
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 |
|---|---|---|
| Health messagingCombinations of personalized health messages (tailored/targeted) and contextualized health messages (reports about localized epidemiologic risk) will be delivered to subjects | Other | I, II, III |
| Health messagescommunity level health messages unrelated to the study originating exposures | Other | IV |
Primary outcome
appropriate immunization behavior
Time frame: six months
3 secondary outcomes
reduced presenteeism for school and work
Time frame: six months
appropriate immunization behaviors for close household/family members
Time frame: six months
knowledge about influenza and beliefs about influenza risk and transmission
Time frame: six months
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 2009.
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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.
Elissa R Weitzman principal investigator
Boston Children's Hospital
Kenneth D Mandl principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health messaging and Health messages in people with Influenza, run by Boston Children's Hospital 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 3 inclusion and 2 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 2009. 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?
appropriate immunization behavior (time frame: six months). 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 1 May 2009.