Condition or disease | Intervention/treatment | Phase |
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Influenza, Vaccination | Behavioral: Messaging Behavioral: Incentive | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22584 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019 |
Actual Study Start Date : | October 6, 2018 |
Actual Primary Completion Date : | March 31, 2019 |
Estimated Study Completion Date : | August 31, 2019 |
Arm | Intervention/treatment |
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No Intervention: Control
No intervention
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Experimental: Messaging
Group will be sent flu vaccine promotion messages via text, email and U.S. Mail
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Behavioral: Messaging
The participants will receive influenza promotion emails, text messages, and U.S. mail from Sendero Health Plans.
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Experimental: Messaging plus incentive
Group will be sent flu vaccine promotion messages via text, email and U.S. Mail, and will be eligible to receive a gift card as incentive for receiving flu vaccine
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Behavioral: Messaging
The participants will receive influenza promotion emails, text messages, and U.S. mail from Sendero Health Plans.
Behavioral: Incentive Participants will be eligible for a gift card to a local grocery store chain as an incentive for obtaining an influenza vaccine
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
The University of Texas System Population Health | |
Austin, Texas, United States, 78701 |
Tracking Information | |||||
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First Submitted Date ICMJE | October 4, 2018 | ||||
First Posted Date ICMJE | October 9, 2018 | ||||
Last Update Posted Date | April 23, 2019 | ||||
Actual Study Start Date ICMJE | October 6, 2018 | ||||
Actual Primary Completion Date | March 31, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Influenza vaccination [ Time Frame: three months ] Receipt of an influenza vaccination documented by medical or pharmacy claim.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019 | ||||
Official Title ICMJE | Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019 | ||||
Brief Summary | • This study will assess the effect of promotional messaging and incentives encouraging influenza vaccination in the Sendero IdealCare policy holders during the 2018-2019 Flu Season. The intervention will consist of influenza vaccination promotion/reminders from Sendero Health Plans to subscribers, including text messages, emails, and tailored direct mail outs, i.e. postcard or a personalized letter, and incentive. The study population consists of approximately 22,500 subscribers enrolled in Sendero IdealCare Plan. The intervention will last approximately four months. The primary endpoints, assessed through administrative claims data, will be getting a flu shot during the 2018-2019 season. Data collected through this study will be used to determine effective components of influenza vaccination promotion campaigns used by a health insurance plan. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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Condition ICMJE | Influenza, Vaccination | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Actual Enrollment ICMJE |
22584 | ||||
Original Estimated Enrollment ICMJE |
22500 | ||||
Estimated Study Completion Date ICMJE | August 31, 2019 | ||||
Actual Primary Completion Date | March 31, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03700281 | ||||
Other Study ID Numbers ICMJE | SenderoFlu2018 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Eileen Nehme, The University of Texas Health Science Center at Tyler | ||||
Study Sponsor ICMJE | The University of Texas Health Science Center at Tyler | ||||
Collaborators ICMJE | Sendero Health Plans, Inc. | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | The University of Texas Health Science Center at Tyler | ||||
Verification Date | April 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |