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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT00531700
Study groupRoleWhat they receive
IExperimentalExposure to both tailored/targeted health messages about influenza and also to reports about contextualized influenza risk
Receives: Other: Health messaging
IIExperimentalExposure to tailored/targeted health messages
Receives: Other: Health messaging
IIIExperimentalExposure to reports about influenza related contextualized risk
Receives: Other: Health messaging
IVActive comparatorComparison 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.

  1. appropriate immunization behavior

    Measured: six months

Secondary outcomes (3)
  1. reduced presenteeism for school and work

    Measured: six months

  2. appropriate immunization behaviors for close household/family members

    Measured: six months

  3. 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.

  1. First posted19 Sep 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionJul 2008
  4. Study completionJan 2009

Resources

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)
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

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.

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Indivo at MIT Clinical Trial NCT00531700 | AzTrials