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

University of Cincinnati

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Behavioral: Educational Intervention - Text Only; Behavioral: Educational Intervention - Text plus DVD/VHS

Study type: Interventional

Funder types: Other

Identifiers

NCT01083862

FIMDM-CS09052/GR090501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 187 patients

Sex: All

Ages: 18 to 87 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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187 participants in 2 patient groups

Educational Intervention - Video & Text

Experimental group

Description:

Educational Intervention - Video \& Text describing "Living with Coronary Artery Disease."

Treatment:

Behavioral: Educational Intervention - Text plus DVD/VHS

Educational Intervention - Text Only

Active Comparator group

Description:

Educational Intervention - Text Only describing "Living with Coronary Artery Disease."

Treatment:

Behavioral: Educational Intervention - Text Only