NCT00531700

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2007

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

May 1, 2009

Status Verified

April 1, 2009

Enrollment Period

9 months

First QC Date

September 18, 2007

Last Update Submit

April 30, 2009

Conditions

Influenza

Keywords

influenzarisk behaviorsimmunizationknowledge attitudes behaviorspersonally controlled health recordIndivo

Outcome Measures

Primary Outcomes (1)

  • appropriate immunization behavior

    six months

Secondary Outcomes (3)

  • reduced presenteeism for school and work

    six months

  • appropriate immunization behaviors for close household/family members

    six months

  • knowledge about influenza and beliefs about influenza risk and transmission

    six months

Study Arms (4)

I

EXPERIMENTAL

Exposure to both tailored/targeted health messages about influenza and also to reports about contextualized influenza risk

Other: Health messaging

II

EXPERIMENTAL

Exposure to tailored/targeted health messages

Other: Health messaging

III

EXPERIMENTAL

Exposure to reports about influenza related contextualized risk

Other: Health messaging

IV

ACTIVE COMPARATOR

Comparison group exposed to community level health promotion messages not generated by the study

Other: Health messages

Interventions

Health messagingOTHER

Combinations of personalized health messages (tailored/targeted) and contextualized health messages (reports about localized epidemiologic risk) will be delivered to subjects

IIIIII
Health messagesOTHER

community level health messages unrelated to the study originating exposures

IV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 and over
  • English speaker
  • Affiliated with study site

You may not qualify if:

  • Younger than 18
  • No access to computers or the internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Influenza, HumanRisk-Taking

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Elissa R Weitzman

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Kenneth D Mandl

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2007

First Posted

September 19, 2007

Study Start

October 1, 2007

Primary Completion

July 1, 2008

Study Completion

January 1, 2009

Last Updated

May 1, 2009

Record last verified: 2009-04

Locations

US(1)