Health Literacy Assessment and Intervention to Reduce Disparities: FLIGHT/VIDAS II

NCT ID: NCT02922439

Last Updated: 2023-09-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-21

Study Completion Date

2020-11-25

Brief Summary

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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.

Detailed Description

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Health literacy is a critically important skill that helps people to become active participants in their health care. The 2003 National Assessment of Adult Literacy showed that more than 75 million Americans had basic health literacy skills, indicating that as many as 1 in 4 Americans can have difficulty understanding information about their healthcare. Persons in racial and ethnic minorities are likely to have even lower levels of health literacy. Twenty-four percent of blacks (9.5 million persons) and 41% of Hispanics (21 million persons) have below basic levels of health literacy. These persons have lower levels of health literacy and compelling evidence, including our own findings (see below), link race and ethnicity to disparities in health via health literacy. Members of minority groups and older adults are more frequently affected by chronic diseases such as cancer, high blood pressure, heart attack, stroke, diabetes, elevated cholesterol, asthma, hepatitis C, HIV infection, mental health disorders and many others. The twin burdens of chronic disease and low levels of health literacy thus fall disproportionately on those most in need - members of minorities and older adults, all of whom likely to experience one or more chronic conditions while often not having the health literacy skills to help them cope.

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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Fatigue Depression Pain Sleep Wake Disorders Chronic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Tailored Intervention

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Control Intervention

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Control Intervention

This intervention will provide information similar to that provided in the control condition, but will not utilize tailoring.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Severe cognitive disability that would preclude the ability to give informed consent
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emory University

OTHER

Sponsor Role collaborator

Nova Southeastern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 23990736 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24637163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24856447 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37066256 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28381395 (View on PubMed)

Related Links

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http://www.flightvidas.org

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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