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

Completed

• Conditions: Diabetes Mellitus Self Management Education; Diabetes

• Registration Number: NCT06840236
• Lead Sponsor: LabStyle Innovations Ltd.

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.

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Status Verified: 2023-04
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Last Update Submitted: 2025-02-17
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8431

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in vaccination rates between the study groups	6 months	differences between the groups in users with diabetes self-reported influenza vaccination status

Secondary Outcome Measures

Name	Time	Method
Content related differences between the groups	6 months	Differences 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?"

Trial Locations

Locations (1)

Labstyle Innovation ltd; 🇮🇱 Caesarea, Israel