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

This study has been completed.
Sponsor:
Collaborator:
Foundation for Informed Medical Decision Making
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01083862
First received: March 5, 2010
Last updated: March 9, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention
Coronary Artery Disease
 Behavioral: Educational Intervention - Text plus DVD/VHS
Behavioral: Educational Intervention - Text Only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • cardiovascular disease knowledge assessment score [ Time Frame: immediate and 6 months ] [ Designated as safety issue: No ]
    knowledge assessment performed prior to educational intervention, immediately after educational intervention and clinician visit, and once more at approximately 6 months


Secondary Outcome Measures:
  • Smoking status [ Time Frame: over 6 months of study ] [ Designated as safety issue: No ]
    Noted initial smoking status and followed whether patients continued to smoke and if so, how much

  • Diet [ Time Frame: Over six months of study ] [ Designated as safety issue: No ]
    Performed MEDFICTs dietary assessment at study start and at study completion, roughly 6 months later

  • Exercise [ Time Frame: Over 6 months of study ] [ Designated as safety issue: No ]
    Performed PASE exercise survey at study start and at study completion.

  • Weight [ Time Frame: over 6 month study ] [ Designated as safety issue: No ]
    Measured weight at study start and at study completion

  • Blood Pressure [ Time Frame: over 6 months of study ] [ Designated as safety issue: No ]
    Measured blood pressure at study start and at study completion.


Enrollment: 187
Study Start Date: October 2005
Study Completion Date: September 2009
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083862

Locations
United States, Ohio
General Internal Medicine Hoxworth Practices
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Foundation for Informed Medical Decision Making
Investigators
Principal Investigator: Mark H Eckman, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Mark H. Eckman, MD, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01083862     History of Changes
Other Study ID Numbers: FIMDM-CS09052/GR090501
Study First Received: March 5, 2010
Last Updated: March 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Health literacy
patient education
health behaviors
 chronic disease management
shared decision-making
patient-centered decision making

Additional relevant MeSH terms:
Chronic Disease
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Disease Attributes
Pathologic Processes
 Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013