Impact of Health Literacy on Outcomes and Effectiveness of Shared Decision Making Programs in Patients With Chronic Diseases
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention - Text plus DVD/VHS
Educational Intervention - Text Only
Sponsored by
About this trial
This is an interventional supportive care trial for Coronary Artery Disease focused on measuring Health literacy, patient education, health behaviors, chronic disease management, shared decision-making, patient-centered decision making
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.
Sites / Locations
- General Internal Medicine Hoxworth Practices
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Educational Intervention - Video & Text
Educational Intervention - Text Only
Arm Description
Educational Intervention - Video & Text describing "Living with Coronary Artery Disease."
Educational Intervention - Text Only describing "Living with Coronary Artery Disease."
Outcomes
Primary Outcome Measures
cardiovascular disease knowledge assessment score
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
Noted initial smoking status and followed whether patients continued to smoke and if so, how much
Diet
Performed MEDFICTs dietary assessment at study start and at study completion, roughly 6 months later
Exercise
Performed PASE exercise survey at study start and at study completion.
Weight
Measured weight at study start and at study completion
Blood Pressure
Measured blood pressure at study start and at study completion.
Full Information
NCT ID
NCT01083862
First Posted
March 5, 2010
Last Updated
March 9, 2010
Sponsor
University of Cincinnati
Collaborators
Foundation for Informed Medical Decision Making
1. Study Identification
Unique Protocol Identification Number
NCT01083862
Brief Title
Impact of Health Literacy on Outcomes and Effectiveness of Shared Decision Making Programs in Patients With Chronic Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Cincinnati
Collaborators
Foundation for Informed Medical Decision Making
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Health literacy, patient education, health behaviors, chronic disease management, shared decision-making, patient-centered decision making
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational Intervention - Video & Text
Arm Type
Experimental
Arm Description
Educational Intervention - Video & Text describing "Living with Coronary Artery Disease."
Arm Title
Educational Intervention - Text Only
Arm Type
Active Comparator
Arm Description
Educational Intervention - Text Only describing "Living with Coronary Artery Disease."
Intervention Type
Behavioral
Intervention Name(s)
Educational Intervention - Text plus DVD/VHS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational Intervention - Text Only
Intervention Description
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 Outcome Measure Information:
Title
cardiovascular disease knowledge assessment score
Description
knowledge assessment performed prior to educational intervention, immediately after educational intervention and clinician visit, and once more at approximately 6 months
Time Frame
immediate and 6 months
Secondary Outcome Measure Information:
Title
Smoking status
Description
Noted initial smoking status and followed whether patients continued to smoke and if so, how much
Time Frame
over 6 months of study
Title
Diet
Description
Performed MEDFICTs dietary assessment at study start and at study completion, roughly 6 months later
Time Frame
Over six months of study
Title
Exercise
Description
Performed PASE exercise survey at study start and at study completion.
Time Frame
Over 6 months of study
Title
Weight
Description
Measured weight at study start and at study completion
Time Frame
over 6 month study
Title
Blood Pressure
Description
Measured blood pressure at study start and at study completion.
Time Frame
over 6 months of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark H Eckman, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Internal Medicine Hoxworth Practices
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Health Literacy on Outcomes and Effectiveness of Shared Decision Making Programs in Patients With Chronic Diseases
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