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

Study Overview
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Brief Summary
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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
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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.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Behavioral: Educational Intervention - Text plus DVD/VHS
* Behavioral: Educational Intervention - Text Only


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 87 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational Intervention - Video & Text<br>Educational Intervention - Video & Text describing Living with Coronary Artery Disease. | Behavioral: Educational Intervention - Text plus DVD/VHS<br>* 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.<br>|
| Active Comparator: Educational Intervention - Text Only<br>Educational Intervention - Text Only describing Living with Coronary Artery Disease. | Behavioral: Educational Intervention - Text Only<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health literacy, patient education, health behaviors, chronic disease management, shared decision-making, patient-centered decision making