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

Depression Clinical Trial

— FV2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922439
• Other study ID #: MD010368
• Status: Completed
• Phase: N/A
• Start date: August 21, 2018
• Est. completion date: November 25, 2020

Study information

• Verified date: September 2023
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: November 25, 2020
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Depression
• Fatigue
• Pain
• Sleep Wake Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	NSU Psychiatry Research Office -- Center for Collaborative Research	Fort Lauderdale	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nova Southeastern University	Emory University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mood	Using the Center for Epidemiological Studies Depression scale, participant mood will be assessed at baseline, six weeks and three months.	Baseline, six weeks, and three months.
Secondary	Sleep quality	Using the Insomnia Severity Index, participant sleep quality will be assessed at six weeks and three months.	Baseline, six weeks, and three months.
Secondary	Patient Activation	Using the Patient Activation Measure (scale), participant mood will be assessed at baseline, six weeks and three months.	Baseline, six weeks, and three months.

External Links

•   Central study website including links to presentations and publications as well as most up-to-date information on study progress.