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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083862
• Other study ID #: FIMDM-CS09052/GR090501
• Status: Completed
• Phase: N/A
• Start date: October 2005
• Est. completion date: September 2009

Study information

• Verified date: November 2023
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: September 2009
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 87 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Coronary Artery Disease

Intervention

Behavioral:
• Educational Intervention - Text plus DVD/VHS
In conjunction with a scheduled clinical visit, consenting patients spent roughly 40 minutes viewing a video program developed by the Foundation for Informed Decision Making (FIMDM), describing life-style and behavior modification for patients "Living with Coronary Artery Disease." They also were given a booklet on the same subject material written at a 5th grade level.
• Educational Intervention - Text Only
In conjunction with a scheduled clinical visit, consenting patients spent roughly 40 minutes reading a booklet developed by the Foundation for Informed Decision Making (FIMDM), describing life-style and behavior modification for patients "Living with Coronary Artery Disease." Subject material was written at a 5th grade level.

Locations

Country	Name	City	State
United States	General Internal Medicine Hoxworth Practices	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Foundation for Informed Medical Decision Making

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular disease knowledge assessment score	knowledge assessment performed prior to educational intervention, immediately after educational intervention and clinician visit, and once more at approximately 6 months	immediate and 6 months
Secondary	Smoking status	Noted initial smoking status and followed whether patients continued to smoke and if so, how much	over 6 months of study
Secondary	Diet	Performed MEDFICTs dietary assessment at study start and at study completion, roughly 6 months later	Over six months of study
Secondary	Exercise	Performed PASE exercise survey at study start and at study completion.	Over 6 months of study
Secondary	Weight	Measured weight at study start and at study completion	over 6 month study
Secondary	Blood Pressure	Measured blood pressure at study start and at study completion.	over 6 months of study