Clinical trial NCT02922439: Health Literacy Assessment and Intervention to Reduce Disparities: FLIGHT/VIDAS II
Official title: Health Literacy Assessment and Intervention to Reduce Disparities: FLIGHT/VIDAS II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Depression
Pain
Sleep Wake Disorders
Chronic Disease
Keywords: chronic disease
multimorbidity
chronic disease self-management
tailored information
mobile applications
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2016-10-04
Enrollment: 335
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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

Primary outcomes:
measure: Health Literacy
timeFrame: Baseline, six weeks, and three months.
Secondary outcomes:
measure: Mood
timeFrame: Baseline, six weeks, and three months.
measure: Sleep quality
timeFrame: Baseline, six weeks, and three months.
measure: Patient Activation
timeFrame: Baseline, six weeks, and three months.
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: NSU Psychiatry Research Office -- Center for Collaborative Research
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Raymond L Ownby, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.