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

March 5, 2010
March 9, 2010
October 2005
October 2007   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01083862 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Impact of Health Literacy on Outcomes and Effectiveness of Shared Decision Making Programs in Patients With Chronic Diseases
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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.
  • 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.
  • Experimental: Educational Intervention - Video & Text
    Educational Intervention - Video & Text describing "Living with Coronary Artery Disease."
    Intervention: Behavioral: Educational Intervention - Text plus DVD/VHS
  • Active Comparator: Educational Intervention - Text Only
    Educational Intervention - Text Only describing "Living with Coronary Artery Disease."
    Intervention: Behavioral: Educational Intervention - Text Only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
187
September 2009
October 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01083862
FIMDM-CS09052/GR090501
No
Mark H. Eckman, MD, University of Cincinnati
University of Cincinnati
Foundation for Informed Medical Decision Making
Principal Investigator: Mark H Eckman, MD University of Cincinnati
University of Cincinnati
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP