NCT06840236

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8,431 (actual)
• Sponsor: LabStyle Innovations Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus Self Management Education
• Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Adapted 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.
BEHAVIORAL	Previously studied based on RCT	Previously studied flu nudge messages in RCT

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2025-02-21
• Last updated: 2025-02-21

Locations

1 site across 1 country: Israel