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Clinical Trials/NCT01083862
NCT01083862
Completed
Not Applicable

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

University of Cincinnati1 site in 1 country187 target enrollmentOctober 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
University of Cincinnati
Enrollment
187
Locations
1
Primary Endpoint
cardiovascular disease knowledge assessment score
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
September 2009
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mark Eckman, M.D.

Professor Emeritus

University of Cincinnati

Eligibility Criteria

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.

Outcomes

Primary Outcomes

cardiovascular disease knowledge assessment score

Time Frame: 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 Outcomes

  • Blood Pressure(over 6 months of study)
  • Weight(over 6 month study)
  • Exercise(Over 6 months of study)
  • Diet(Over six months of study)
  • Smoking status(over 6 months of study)

Study Sites (1)

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