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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 187
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • General Internal Medicine Hoxworth Practices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational Intervention - Video & Text; Educational Intervention - Video & Text describing "Living with Coronary Artery Disease."	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.
Active Comparator: Educational Intervention - Text Only; Educational Intervention - Text Only describing "Living with Coronary Artery Disease."	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: Foundation for Informed Medical Decision Making
• Investigators: Principal Investigator: Mark H Eckman, MD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: March 5, 2010
• First Submitted That Met QC Criteria: March 9, 2010
• First Posted (Estimated): March 10, 2010

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: patient education; Health literacy; chronic disease management; shared decision-making; health behaviors; patient-centered decision making
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Coronary Disease; Coronary Artery Disease; Chronic Disease
• Other Study ID Numbers: FIMDM-CS09052/GR090501