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Completed

NCT Number: NCT01083862

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Coronary Disease Health Behavior Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–87 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Internal Medicine Hoxworth Practices

Cincinnati, Ohio, 45267, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational Intervention - Text plus DVD/VHS

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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

  1. Smoking status

    Time frame: over 6 months of study

    Noted initial smoking status and followed whether patients continued to smoke and if so, how much

  2. Diet

    Time frame: Over six months of study

    Performed MEDFICTs dietary assessment at study start and at study completion, roughly 6 months later

  3. Exercise

    Time frame: Over 6 months of study

    Performed PASE exercise survey at study start and at study completion.

  4. Weight

    Time frame: over 6 month study

    Measured weight at study start and at study completion

  5. Blood Pressure

    Time frame: over 6 months of study

    Measured blood pressure at study start and at study completion.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • Foundation for Informed Medical Decision Making

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2009
First posted
Mar 10, 2010
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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