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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02922439
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : January 7, 2020
University of Miami
Emory University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Fatigue Depression Pain Sleep Wake Disorders Chronic Disease Behavioral: Tailored Intervention Behavioral: Control Intervention Not Applicable

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:

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Health Literacy Assessment and Intervention to Reduce Disparities: FLIGHT/VIDAS II
Actual Study Start Date : August 21, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02922439

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Contact: Rosemary Davenport, RN 954-262-1804
Contact: Raymond L Ownby, MD, PhD 954-262-1481

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United States, Florida
NSU Psychiatry Research Office -- Center for Collaborative Research Recruiting
Fort Lauderdale, Florida, United States, 33328
Contact: Rosemary Davenport, MSN, ARNP    954-262-1804   
Contact: Raymond L Ownby, MD, PhD    9542621481   
Sponsors and Collaborators
Nova Southeastern University
University of Miami
Emory University
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Principal Investigator: Raymond L Ownby, MD, PhD Nova Southeastern University

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nova Southeastern University Identifier: NCT02922439    
Other Study ID Numbers: MD010368
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At study conclusion a cleaned data set will be made available to interested researchers.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nova Southeastern University:
chronic disease
chronic disease self-management
tailored information
mobile applications
Additional relevant MeSH terms:
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Sleep Wake Disorders
Chronic Disease
Signs and Symptoms
Disease Attributes
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Mental Disorders