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Influenza Vaccination Digital Interventions for People Living With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03870997
Recruitment Status : Completed
First Posted : March 12, 2019
Results First Posted : June 4, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Evidation Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Diabetes Digital Intervention Behavioral: Generic Digital Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Influenza Vaccination Digital Interventions for People Living With Diabetes
Actual Study Start Date : September 12, 2018
Actual Primary Completion Date : April 8, 2019
Actual Study Completion Date : April 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870997


Locations
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United States, California
Evidation Health
San Mateo, California, United States, 94401
Sponsors and Collaborators
Evidation Health
Sanofi Pasteur, a Sanofi Company
  Study Documents (Full-Text)

Documents provided by Evidation Health:
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Responsible Party: Evidation Health
ClinicalTrials.gov Identifier: NCT03870997    
Other Study ID Numbers: EH-008
First Posted: March 12, 2019    Key Record Dates
Results First Posted: June 4, 2020
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases