NCT01009645

Brief Summary

The purpose of this study is to evaluate whether message design of educational materials increases vaccination rates among participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

September 18, 2012

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

November 6, 2009

Results QC Date

April 25, 2012

Last Update Submit

October 25, 2023

Conditions

Influenza Vaccination

Keywords

educationvaccinationpreventive servicePrevention & Control

Outcome Measures

Primary Outcomes (1)

  • Influenza Vaccination

    The primary outcome is receipt of influenza vaccination at appointment directly following the post-test. A pre-test was completed by participants during a telephone interview that occurred approximately two weeks prior to a scheduled clinic appointment. The post-test was completed via an in-person interview by participants immediately prior to their scheduled appointment. That is, the participants met with the Research Assistant, completed the post-test, and then proceeded to see their physician for a previously scheduled office visit.

    1 week following randomization

Secondary Outcomes (1)

  • Recall Accuracy

    1 week following receipt of message

Study Arms (4)

Fact Only

EXPERIMENTAL

The educational message used will contain facts only.

Behavioral: Fact Only Education Message

Fact and Myth

EXPERIMENTAL

The educational material seen by this arm will contain facts and myths only.

Behavioral: Fact and Myth Educational Message

Fact, Myth, Why

EXPERIMENTAL

The educational material seen by this arm will contain myths, facts, and refutations of the myths.

Behavioral: Fact, Myth, Why Educational Message

Control

PLACEBO COMPARATOR

This arm will receive fact/myth educational materials originally developed and used by the CDC.

Behavioral: Control Educational Message

Interventions

Fact Only Education MessageBEHAVIORAL

Participants randomized to this intervention will receive an educational brochure listing the facts of the influenza vaccine.

Also known as: Fact Only
Fact Only
Fact and Myth Educational MessageBEHAVIORAL

Participants randomized to this intervention will receive an educational brochure listing the facts and myths of the influenza vaccine.

Also known as: Fact & Myth
Fact and Myth
Fact, Myth, Why Educational MessageBEHAVIORAL

Participants randomized to this intervention will receive an educational brochure listing the facts, myths, and refutation of the myths of the influenza vaccine.

Also known as: Fact, Myth, Why
Fact, Myth, Why
Control Educational MessageBEHAVIORAL

Participants randomized to this intervention will receive an educational brochure created and used by the CDC in a previous influenza season.

Also known as: Control
Control

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant must have a scheduled appointment at least 6 weeks in advance in either the GIM or Geriatrics clinics at NMFF.
  • Participant must be a patient of Northwestern Medical Faculty Foundation.
  • Participant does not intend to receive the influenza vaccine.

You may not qualify if:

  • Participant has a diagnosis of Alzheimer's Disease or Dementia
  • Participant has received an influenza vaccination during either the last influenza season or the current.
  • The scheduled visit is the participant's first time being seen by this doctor (appointment is to establish care in the clinic).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medical Faculty Foundation General Internal Medicine and Geriatric Clinics

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

SUPT16H protein, human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Limitations and Caveats

Low participation in the trial due to the emergence of H1N1; many individuals \>50 years of age opted to receive seasonal flu vaccine as they were initially unable to receive the H1N1 vaccine. Hence, the available study population shrank markedly.

Results Point of Contact

Title
Kenzie Cameron, PhD, MPH
Organization
Northwestern University
kcameron@northwestern.edu
312-503-3910

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2009

First Posted

November 9, 2009

Study Start

September 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

October 30, 2023

Results First Posted

September 18, 2012

Record last verified: 2023-10

Locations

US(1)