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

Not Applicable

Completed

• Conditions: Fatigue; Depression; Chronic Disease; Pain; Sleep Wake Disorders
• Interventions: Behavioral: Tailored Intervention; Behavioral: Control Intervention

• Registration Number: NCT02922439
• Lead Sponsor: Nova Southeastern University

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.

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 Timeline

• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-04
• Study Start: 2018-08-21
• Primary Completion: 2020-11-25
• Study Completion: 2020-11-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

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

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Exclusion Criteria

• Severe cognitive disability that would preclude the ability to give informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tailored Intervention	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.
Control	Control Intervention	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.

Primary Outcome Measures

Name	Time	Method
Health Literacy	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NSU Psychiatry Research Office -- Center for Collaborative Research; 🇺🇸 Fort Lauderdale, Florida, United States