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| Name | Class |
|---|---|
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Digital Intervention | Experimental |
| |
| Generic Digital Intervention | Experimental |
| |
| No Influenza Vaccination Intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Digital Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evidation Health | San Mateo | California | 94401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34535755 | Derived | 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. |
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Existing members of the online health platform Achievement who met the inclusion criteria were blinded to their study participation status and were not asked to take any action to enroll in the study. Participants were randomized to one of the digital interventions or to no intervention. All study activities were conducted virtually.
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| ID | Title | Description |
|---|---|---|
| FG000 | People With Diabetes: Intervention | Individuals with self-reported diabetes who receive the Diabetes Digital Intervention |
| FG001 | People With Diabetes: Control | Individuals with self-reported diabetes who received no digital intervention |
| FG002 | Normal Controls-Similar: Intervention | Individuals without self-reported diabetes who were similar to PWD based on demographics and activity tracker data and received the Generic Digital Intervention |
| FG003 | Normal Controls-Similar: Control | Individuals without self-reported diabetes who were similar to PWD based on demographics and activity tracker data and received no digital intervention |
| FG004 | Normal Controls: Intervention | Individuals without self-reported diabetes and were not in NC-S based on demographics and activity tracker data, but were similar to PWD with regards to age and gender distribution and received the Generic Digital Intervention |
| FG005 | Normal Controls: Controls | Individuals without self-reported diabetes and were not in NC-S based on demographics and activity tracker data, but were similar to PWD with regards to age and gender distribution and received no Digital Intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Overall study population
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| ID | Title | Description |
|---|---|---|
| BG000 | People With Diabetes:Intervention | Participant demographics |
| BG001 | People With Diabetes: Control | Participant demographics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 5,158 in intervention group and 5,271 in control group | Posted | Count of Participants | Participants | No | 6 months |
|
|
6 months
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | People With Diabetes: Intervention | Individuals with self-reported diabetes who receive the Diabetes Digital Intervention |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Director, Digital Health Outcomes | Evidation Health | 650-389-9550 | results@evidation.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2018 | Apr 13, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| Generic Digital Intervention | Behavioral | 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. |
|
| BG002 | Normal Controls-Similar: Intervention | Participant demographics |
| BG003 | Normal Controls-Similar : Control | Participant demographics |
| BG004 | Normal Controls: Intervention | Participant demographics |
| BG005 | Normal Controls: Control | Participant demographics |
| BG006 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | People With Diabetes: Control | Individuals with self-reported diabetes who received no digital intervention | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Normal Controls-Similar: Intervention | Individuals without self-reported diabetes who were similar to PWD based on demographics and activity tracker data and received the Generic Digital Intervention | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Normal Controls-Similar: Control | Individuals without self-reported diabetes who were similar to PWD based on demographics and activity tracker data and received no digital intervention | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Normal Controls: Intervention | Individuals without self-reported diabetes and were not in NC-S based on demographics and activity tracker data, but were similar to PWD with regards to age and gender distribution and received the Generic Digital Intervention | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Normal Controls:Control | Individuals without self-reported diabetes and were not in NC-S based on demographics and activity tracker data, but were similar to PWD with regards to age and gender distribution and received no Digital Intervention | 0 | 0 | 0 | 0 | 0 | 0 |
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