Influenza Vaccination Digital Interventions for People Living With Diabetes

June 2, 2020 updated by: Evidation Health
The overall objective of this prospective randomized controlled study is to assess and quantify the impact of digital interventions to increase vaccination rates and vaccination-related outcomes in a connected population with self-reported diabetes. The digital intervention will be delivered via a campaign sent to participants, with interventions varying with each study arm. Participants will be blinded to study participation status.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94321

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

  • United States
    • California
      • San Mateo, California, United States, 94401
        • Evidation Health

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years old
  • Lives in the U.S.

Exclusion Criteria:

  • < 18 years old
  • Does not live in the U.S.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetes Digital Intervention
Behavioral: Diabetes Digital Intervention
The Diabetes Digital Intervention is a digital campaign that provides interactive ways (e.g., videos, infographics, quizzes) for individuals to learn about influenza and related complications, and the importance of influenza vaccination. It is tailored to people living with diabetes and highlights the importance of influenza vaccination for this specific patient population.
Experimental: Generic Digital Intervention
Behavioral: Generic Digital Intervention
The Generic Digital Intervention is a digital campaign that provides interactive ways (e.g., videos, infographics, quizzes) for individuals to learn about influenza and related complications, and the importance of influenza vaccination. It provides generic influenza vaccination interventions that can be applicable to any adult who should receive influenza vaccination.
No Intervention: No Influenza Vaccination Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Self-reported Influenza Vaccination in People With Diabetes
Time Frame: 6 months
Number of participants with self-reported influenza vaccination in People With Diabetes: Intervention arm as compared to People With Diabetes: Control arm
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evidation Health

Collaborators

Sanofi Pasteur, a Sanofi Company

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

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 (Actual)

September 12, 2018

Primary Completion (Actual)

April 8, 2019

Study Completion (Actual)

April 8, 2019

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

March 8, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 2, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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