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Digital Health Intervention On Awareness Of Vaccination Against Influenza Among Adults With Diabetes

Digital Health Intervention On Awareness Of Vaccination Against Influenza Among Adults With Diabetes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06840236
Enrollment
8431
Registered
2025-02-21
Start date
2022-09-01
Completion date
2023-03-30
Last updated
2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus Self Management Education

Keywords

digital health; diabetes management; influenza vaccination; flu vaccination awareness

Brief summary

The study leveraged the Dario digital health platform to retrospectively analyze data from 64,904 users with diabetes assigned by the platform into three groups: Group A received previously studied monthly flu nudge messages; Group B received an adapted intervention with 2-3 monthly messages; Group C served as the control with no intervention. Surveys were conducted at baseline, three months, and six months to assess vaccination status, awareness of influenza risks, and recollection of educational content. Statistical analyses, including logistic regression, Chi-square tests, and t-tests, were used to evaluate differences between groups.

Detailed description

The goal of this study was to retrospectively evaluate the effectiveness of an adapted digital nudge intervention that was designed previously in an RCT setting to increase influenza vaccination rates for PWD in real world setting. The primary objective was to examine the difference in self-reported influenza vaccination rates in three groups: PWD who received the intervention using a previously published approach (group A), PWD who received an adapted digital intervention (group B) and PWD who received no intervention (group C or control). A secondary aim was to investigate whether the intervention led to differences in awareness and knowledge across study groups and examined the relationship between awareness of influenza risks and vaccination rates. The data was collected between September 2022 and March 2023 to evaluate the effectiveness of an adapted digital nudge intervention designed to increase influenza vaccination rates among people with diabetes (PWD) in a real-world setting. The intervention builds on a previously conducted randomized controlled trial (RCT). Users were automatically assigned to three groups via the customer engagement platform using a randomization algorithm to assign each selected user to one of the test variations. This ensured that each user had an equal chance of being placed in any of the groups. The three groups are defined as follows: group A received flu nudge messages as described previously in a randomized clinical trial with one message given each month for six months; Group B received similar messages that were adapted in frequency with 2-3 messages per month for six months and matched the Dario platform's user experience; group C received no flu nudges (Control). No compensation was offered. The intervention messages included education and recommendations related to the importance of getting flu vaccination in the diabetes population.

Interventions

BEHAVIORALAdapted Flu nudge messages

Adapted Flu nudge messages - digital health intervention aimed at improving influenza vaccination rates among adults with diabetes at Dario digital platform approach.

BEHAVIORALPreviously studied based on RCT

Previously studied flu nudge messages in RCT

Sponsors

LabStyle Innovations Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

subjects from the United States utilizing a Dario application who reported in the app during registration that they had a diagnosis of type 1 or 2 diabetes and who were active on the platform (logged into the app) during the 12-month period up to Sep 2022.

Exclusion criteria

subjects that are not using Dario platform

Design outcomes

Primary

MeasureTime frameDescription
Differences in vaccination rates between the study groups6 monthsdifferences between the groups in users with diabetes self-reported influenza vaccination status

Secondary

MeasureTime frameDescription
Content related differences between the groups6 monthsDifferences in awareness and knowledge retention levels between the groups measured by response to the question: Do you know the risks getting the flu has for someone with diabetes and differences in recollection of educational content between the groups, measured by a self-reported question: Do you remember seeing any of these messages?

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026