Health Literacy Assessment and Intervention to Reduce Disparities: FLIGHT/VIDAS II
NCT ID: NCT02922439
Last Updated: 2023-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
335 participants
INTERVENTIONAL
2018-08-21
2020-11-25
Brief Summary
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Detailed Description
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Chronic disease self-management (CDSM) is a logical target for a general health literacy intervention. In an approach that cuts across specific diseases. CDSM targets problems and skills needed to cope with issues such as fatigue, pain, stress, depression, sleep disturbance and treatment adherence. Studies show that in-person CDSM classes improve patients' functioning and reduce healthcare utilization, but their availability is limited due to the lack of qualified personnel and cost. Similarly, while interventions have been developed to improve health literacy, they are difficult to scale to levels needed to meet the challenge of low health literacy (for more than 40 million persons) due to their cost. Effective interventions with the potential for wider dissemination at reasonable costs are urgently needed.
In a previous study, the investigators showed that a computer-delivered tailored information intervention targeting health literacy that can deployed either as an information kiosk in a clinical office or on the Internet could be cost-effective in improving patients' health literacy and adherence. It is not clear, however, whether the same sort of computer-delivered, multimedia and interactive approach will be effective in improving CDSM skills in persons with low baseline levels of health literacy, and if it is, whether its effects will extend beyond health literacy to general health, self-efficacy, activation, and treatment adherence. In this follow-up study the investigators will evaluate this possibility by creating a personally relevant computer-delivered intervention targeting CDSM and health literacy among African-Americans, Hispanics, and white non-Hispanics:
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tailored Intervention
Individuals will interact with a chronic disease self-management application that provides information tailored to age, race, language (English or Spanish) and level of health literacy.
Tailored Intervention
The intervention will focus on improving the health literacy of low literacy individuals by providing chronic disease self-management information tailored to cultural and linguistic characteristics of participants.
Control
Individuals will interact with a chronic disease self-management application that provides the same information as the experimental intervention but is not personally tailored to level of health literacy.
Control Intervention
This intervention will provide information similar to that provided in the control condition, but will not utilize tailoring.
Interventions
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Tailored Intervention
The intervention will focus on improving the health literacy of low literacy individuals by providing chronic disease self-management information tailored to cultural and linguistic characteristics of participants.
Control Intervention
This intervention will provide information similar to that provided in the control condition, but will not utilize tailoring.
Eligibility Criteria
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Inclusion Criteria
* Health literacy at or below 8th grade level as assessed by screening measure
* Able to provide informed consent
Exclusion Criteria
40 Years
ALL
Yes
Sponsors
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Emory University
OTHER
Nova Southeastern University
OTHER
Responsible Party
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Principal Investigators
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Raymond L Ownby, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Nova Southeastern University
Locations
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NSU Psychiatry Research Office -- Center for Collaborative Research
Fort Lauderdale, Florida, United States
Countries
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References
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Ownby RL, Acevedo A, Waldrop-Valverde D, Jacobs RJ, Caballero J, Davenport R, Homs AM, Czaja SJ, Loewenstein D. Development and initial validation of a computer-administered health literacy assessment in Spanish and English: FLIGHT/VIDAS. Patient Relat Outcome Meas. 2013 Aug 19;4:21-35. doi: 10.2147/PROM.S48384. eCollection 2013.
Ownby RL, Acevedo A, Waldrop-Valverde D, Jacobs RJ, Caballero J. Abilities, skills and knowledge in measures of health literacy. Patient Educ Couns. 2014 May;95(2):211-7. doi: 10.1016/j.pec.2014.02.002. Epub 2014 Feb 16.
Ownby RL, Acevedo A, Jacobs RJ, Caballero J, Waldrop-Valverde D. Quality of life, health status, and health service utilization related to a new measure of health literacy: FLIGHT/VIDAS. Patient Educ Couns. 2014 Sep;96(3):404-10. doi: 10.1016/j.pec.2014.05.005. Epub 2014 May 14.
Ownby RL, Waldrop D, Davenport R, Simonson M, Caballero J, Thomas-Purcell K, Purcell D, Ayala V, Gonzalez J, Patel N, Kondwani K. A mobile app for chronic disease self-management for individuals with low health literacy: A multisite randomized controlled clinical trial. medRxiv [Preprint]. 2023 Apr 3:2023.04.01.23288020. doi: 10.1101/2023.04.01.23288020.
Ownby RL, Acevedo A, Waldrop-Valverde D, Caballero J, Simonson M, Davenport R, Kondwani K, Jacobs RJ. A Mobile App for Chronic Disease Self-Management: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Apr 5;6(4):e53. doi: 10.2196/resprot.7272.
Related Links
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Central study website including links to presentations and publications as well as most up-to-date information on study progress.
Other Identifiers
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MD010368
Identifier Type: -
Identifier Source: org_study_id
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