Health Literacy Assessment and Intervention to Reduce Disparities: FLIGHT/VIDAS II (FV2)
Primary Purpose
Fatigue, Depression, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Intervention
Control Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue focused on measuring chronic disease, multimorbidity, chronic disease self-management, tailored information, mobile applications
Eligibility Criteria
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
Sites / Locations
- NSU Psychiatry Research Office -- Center for Collaborative Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tailored Intervention
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Health Literacy
Using the FLIGHT/VIDAS health literacy scale, change in health literacy will be assessed at baseline, 6 weeks and three months.
Secondary Outcome Measures
Mood
Using the Center for Epidemiological Studies Depression scale, participant mood will be assessed at baseline, six weeks and three months.
Sleep quality
Using the Insomnia Severity Index, participant sleep quality will be assessed at six weeks and three months.
Patient Activation
Using the Patient Activation Measure (scale), participant mood will be assessed at baseline, six weeks and three months.
Full Information
NCT ID
NCT02922439
First Posted
September 28, 2016
Last Updated
September 15, 2023
Sponsor
Nova Southeastern University
Collaborators
Emory University
1. Study Identification
Unique Protocol Identification Number
NCT02922439
Brief Title
Health Literacy Assessment and Intervention to Reduce Disparities: FLIGHT/VIDAS II
Acronym
FV2
Official Title
Health Literacy Assessment and Intervention to Reduce Disparities: FLIGHT/VIDAS II
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 21, 2018 (Actual)
Primary Completion Date
November 25, 2020 (Actual)
Study Completion Date
November 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Southeastern University
Collaborators
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Depression, Pain, Sleep Wake Disorders, Chronic Disease
Keywords
chronic disease, multimorbidity, chronic disease self-management, tailored information, mobile applications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
335 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tailored Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tailored Intervention
Intervention Description
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
Intervention Name(s)
Control Intervention
Intervention Description
This intervention will provide information similar to that provided in the control condition, but will not utilize tailoring.
Primary Outcome Measure Information:
Title
Health Literacy
Description
Using the FLIGHT/VIDAS health literacy scale, change in health literacy will be assessed at baseline, 6 weeks and three months.
Time Frame
Baseline, six weeks, and three months.
Secondary Outcome Measure Information:
Title
Mood
Description
Using the Center for Epidemiological Studies Depression scale, participant mood will be assessed at baseline, six weeks and three months.
Time Frame
Baseline, six weeks, and three months.
Title
Sleep quality
Description
Using the Insomnia Severity Index, participant sleep quality will be assessed at six weeks and three months.
Time Frame
Baseline, six weeks, and three months.
Title
Patient Activation
Description
Using the Patient Activation Measure (scale), participant mood will be assessed at baseline, six weeks and three months.
Time Frame
Baseline, six weeks, and three months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond L Ownby, MD, PhD
Organizational Affiliation
Nova Southeastern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NSU Psychiatry Research Office -- Center for Collaborative Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33328
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
23990736
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.
Results Reference
background
PubMed Identifier
24637163
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.
Results Reference
background
PubMed Identifier
24856447
Citation
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.
Results Reference
background
PubMed Identifier
28381395
Citation
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.
Results Reference
derived
Links:
URL
http://www.flightvidas.org
Description
Central study website including links to presentations and publications as well as most up-to-date information on study progress.
Learn more about this trial
Health Literacy Assessment and Intervention to Reduce Disparities: FLIGHT/VIDAS II
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