Impact of Health Literacy on Outcomes and Effectiveness of Shared Decision Making Programs in Patients With Chronic Diseases

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Behavioral: Educational Intervention - Text plus DVD/VHS; Behavioral: Educational Intervention - Text Only

• Registration Number: NCT01083862
• Lead Sponsor: University of Cincinnati

Brief Summary

Study objective was to explore the impact of health literacy on effectiveness of an educational intervention describing life-style and behavior modification for patients "Living with Coronary Artery Disease." Our hypothesis was that a VHS/DVD version of this educational program would be "superior" to printed material alone in its impact on patients' knowledge about coronary artery disease and important life-style changes. Furthermore, we believed this effect would be most notable among patients with low health literacy. We also were interested in the impact of the interventions on secondary outcomes including - health behaviors, health outcomes and patients' subjective experiences.

Detailed Description

187 patients with coronary artery disease (CAD) were randomized to one of two educational interventions prior to scheduled ambulatory visit: VHS/DVD plus printed booklet; or booklet alone. Main measures included health literacy, CAD knowledge assessment; clinical outcomes and health behaviors including - blood pressure, weight, smoking status, exercise and dietary habits.

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2007-10
• Study Completion: 2009-09
• Study First Submitted: 2010-03-05
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

• Age >= 18,
• Diagnosis of ischemic heart disease.

Exclusion Criteria

• Nursing home resident,
• Did not speak English, or
• Had a significant visual impairment that precluded their ability to read or watch television.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational Intervention - Video & Text	Educational Intervention - Text plus DVD/VHS	Educational Intervention - Video \& Text describing "Living with Coronary Artery Disease."
Educational Intervention - Text Only	Educational Intervention - Text Only	Educational Intervention - Text Only describing "Living with Coronary Artery Disease."

Primary Outcome Measures

Name	Time	Method
cardiovascular disease knowledge assessment score	immediate and 6 months	knowledge assessment performed prior to educational intervention, immediately after educational intervention and clinician visit, and once more at approximately 6 months

Secondary Outcome Measures

Name	Time	Method
Weight	over 6 month study	Measured weight at study start and at study completion
Blood Pressure	over 6 months of study	Measured blood pressure at study start and at study completion.
Diet	Over six months of study	Performed MEDFICTs dietary assessment at study start and at study completion, roughly 6 months later
Smoking status	over 6 months of study	Noted initial smoking status and followed whether patients continued to smoke and if so, how much
Exercise	Over 6 months of study	Performed PASE exercise survey at study start and at study completion.

Trial Locations

Locations (1)

General Internal Medicine Hoxworth Practices; 🇺🇸 Cincinnati, Ohio, United States