Health Literacy Assessment and Intervention to Reduce Disparities: FLIGHT/VIDAS II
FV2
1 other identifier
interventional
335
1 country
1
Brief Summary
The purpose of this study will to be to evaluate the effects of a mobile intervention focused on improving the chronic disease self management skills of individuals with low health literacy. The intervention will provide information that culturally and linguistically tailored to participants' level of health literacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2016
CompletedFirst Posted
Study publicly available on registry
October 4, 2016
CompletedStudy Start
First participant enrolled
August 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2020
CompletedSeptember 18, 2023
September 1, 2023
2.3 years
September 28, 2016
September 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health Literacy
Using the FLIGHT/VIDAS health literacy scale, change in health literacy will be assessed at baseline, 6 weeks and three months.
Baseline, six weeks, and three months.
Secondary Outcomes (3)
Mood
Baseline, six weeks, and three months.
Sleep quality
Baseline, six weeks, and three months.
Patient Activation
Baseline, six weeks, and three months.
Study Arms (2)
Tailored Intervention
EXPERIMENTALIndividuals 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.
Control
ACTIVE COMPARATORIndividuals 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.
Interventions
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.
This intervention will provide information similar to that provided in the control condition, but will not utilize tailoring.
Eligibility Criteria
You may qualify if:
- Have at least one chronic condition (cardiovascular disease,; arthritis; cancer; lung disease, osteoporosis, depression and others treated with at least one medication
- Health literacy at or below 8th grade level as assessed by screening measure
- Able to provide informed consent
You may not qualify if:
- Severe cognitive disability that would preclude the ability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nova Southeastern Universitylead
- Emory Universitycollaborator
Study Sites (1)
NSU Psychiatry Research Office -- Center for Collaborative Research
Fort Lauderdale, Florida, 33328, United States
Related Publications (5)
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.
PMID: 23990736BACKGROUNDOwnby 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.
PMID: 24637163BACKGROUNDOwnby 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.
PMID: 24856447BACKGROUNDOwnby 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.
PMID: 37066256DERIVEDOwnby 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.
PMID: 28381395DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raymond L Ownby, MD, PhD
Nova Southeastern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2016
First Posted
October 4, 2016
Study Start
August 21, 2018
Primary Completion
November 25, 2020
Study Completion
November 25, 2020
Last Updated
September 18, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be made available approximately 12 months after the date of the last participant completion.
- Access Criteria
- Data will be made available to any interested investigator.
At study conclusion a cleaned data set will be made available to interested researchers.