Health Literacy Assessment and Intervention to Reduce Disparities: FLIGHT/VIDAS II (FV2)

September 15, 2023 updated by: Nova Southeastern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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:

Study Type

Interventional

Enrollment (Actual)

335

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33328
        • NSU Psychiatry Research Office -- Center for Collaborative Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
Behavioral: Control Intervention
This intervention will provide information similar to that provided in the control condition, but will not utilize tailoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Literacy
Time Frame: Baseline, six weeks, and three months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood
Time Frame: Baseline, six weeks, and three months.
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.
Sleep quality
Time Frame: Baseline, six weeks, and three months.
Using the Insomnia Severity Index, participant sleep quality will be assessed at six weeks and three months.
Baseline, six weeks, and three months.
Patient Activation
Time Frame: Baseline, six weeks, and three months.
Using the Patient Activation Measure (scale), participant mood will be assessed at baseline, six weeks and three months.
Baseline, six weeks, and three months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Southeastern University

Collaborators

Emory University

Investigators

  • Principal Investigator: Raymond L Ownby, MD, PhD, Nova Southeastern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2018

Primary Completion (Actual)

November 25, 2020

Study Completion (Actual)

November 25, 2020

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 30, 2016

First Posted (Estimated)

October 4, 2016

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD010368

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At study conclusion a cleaned data set will be made available to interested researchers.

IPD Sharing Time Frame

Data will be made available approximately 12 months after the date of the last participant completion.

IPD Sharing Access Criteria

Data will be made available to any interested investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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