An interventional study of Tailored Intervention and Control Intervention in Fatigue, Depression and Pain, sponsored by Nova Southeastern University. Completed at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by Nova Southeastern University · Not applicable, Interventional, and Treatment
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.
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:
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's enrollment of 335 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →Nova Southeastern University is the lead sponsor of 80 studies on the registry; 18 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
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
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
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.
This intervention will provide information similar to that provided in the control condition, but will not utilize tailoring.
Health Literacy
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.
Mood
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.
Sleep quality
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.
Patient Activation
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.
Plan to share: Yes — At study conclusion a cleaned data set will be made available to interested researchers.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Nova Southeastern University