NCT03870997

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94,321

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable diabetes

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 4, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

March 7, 2019

Results QC Date

April 23, 2020

Last Update Submit

June 2, 2020

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Self-reported Influenza Vaccination in People With Diabetes

    Number of participants with self-reported influenza vaccination in People With Diabetes: Intervention arm as compared to People With Diabetes: Control arm

    6 months

Study Arms (3)

Diabetes Digital Intervention

EXPERIMENTAL
Behavioral: Diabetes Digital Intervention

Generic Digital Intervention

EXPERIMENTAL
Behavioral: Generic Digital Intervention

No Influenza Vaccination Intervention

NO INTERVENTION

Interventions

Diabetes Digital InterventionBEHAVIORAL

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.

Diabetes Digital Intervention
Generic Digital InterventionBEHAVIORAL

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.

Generic Digital Intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evidation Health

San Mateo, California, 94401, United States

Location

Related Publications (1)

  • Lee JL, Foschini L, Kumar S, Juusola J, Liska J, Mercer M, Tai C, Buzzetti R, Clement M, Cos X, Ji L, Kanumilli N, Kerr D, Montanya E, Muller-Wieland D, Ostenson CG, Skolnik N, Woo V, Burlet N, Greenberg M, Samson SI. Digital intervention increases influenza vaccination rates for people with diabetes in a decentralized randomized trial. NPJ Digit Med. 2021 Sep 17;4(1):138. doi: 10.1038/s41746-021-00508-2.

    PMID: 34535755DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

Study population may not be generalizable to the entire U.S. population with diabetes. Baseline vaccination rates were relatively high and population was generally aware of their health.

Results Point of Contact

Title
Executive Director, Digital Health Outcomes
Organization
Evidation Health
results@evidation.com
650-389-9550

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 12, 2019

Study Start

September 12, 2018

Primary Completion

April 8, 2019

Study Completion

April 8, 2019

Last Updated

June 9, 2020

Results First Posted

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)