Impact of Health Literacy on Outcomes and Effectiveness of Shared Decision Making Programs in Patients With Chronic Diseases
1 other identifier
interventional
187
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Oct 2005
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 5, 2010
CompletedFirst Posted
Study publicly available on registry
March 10, 2010
CompletedDecember 7, 2023
November 1, 2023
2 years
March 5, 2010
November 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
immediate and 6 months
Secondary Outcomes (5)
Smoking status
over 6 months of study
Diet
Over six months of study
Exercise
Over 6 months of study
Weight
over 6 month study
Blood Pressure
over 6 months of study
Study Arms (2)
Educational Intervention - Video & Text
EXPERIMENTALEducational Intervention - Video \& Text describing "Living with Coronary Artery Disease."
Educational Intervention - Text Only
ACTIVE COMPARATOREducational Intervention - Text Only describing "Living with Coronary Artery Disease."
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age \>= 18,
- Diagnosis of ischemic heart disease.
You may not qualify if:
- Nursing home resident,
- Did not speak English, or
- Had a significant visual impairment that precluded their ability to read or watch television.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Internal Medicine Hoxworth Practices
Cincinnati, Ohio, 45267, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark H Eckman, MD
University of Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Emeritus
Study Record Dates
First Submitted
March 5, 2010
First Posted
March 10, 2010
Study Start
October 1, 2005
Primary Completion
October 1, 2007
Study Completion
September 1, 2009
Last Updated
December 7, 2023
Record last verified: 2023-11