We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01083862
First Posted: March 10, 2010
Last Update Posted: March 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Foundation for Informed Medical Decision Making
Information provided by:
University of Cincinnati
  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: None (Open Label)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • Diet [ Time Frame: Over six months of study ]
    Performed MEDFICTs dietary assessment at study start and at study completion, roughly 6 months later

  • Exercise [ Time Frame: Over 6 months of study ]
    Performed PASE exercise survey at study start and at study completion.

  • Weight [ Time Frame: over 6 month study ]
    Measured weight at study start and at study completion

  • Blood Pressure [ Time Frame: over 6 months of study ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mark H. Eckman, MD, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01083862     History of Changes
Other Study ID Numbers: FIMDM-CS09052/GR090501
First Submitted: March 5, 2010
First Posted: March 10, 2010
Last Update Posted: March 10, 2010
Last Verified: March 2010

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