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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01083862
Enrollment
187
Registered
2010-03-10
Start date
2005-10-31
Completion date
2009-09-30
Last updated
2023-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Health literacy, patient education, health behaviors, chronic disease management, shared decision-making, patient-centered decision making

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.

Interventions

BEHAVIORALEducational 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.

BEHAVIORALEducational 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.

Sponsors

Foundation for Informed Medical Decision Making
CollaboratorOTHER
University of Cincinnati
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 87 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
cardiovascular disease knowledge assessment scoreimmediate and 6 monthsknowledge assessment performed prior to educational intervention, immediately after educational intervention and clinician visit, and once more at approximately 6 months

Secondary

MeasureTime frameDescription
Smoking statusover 6 months of studyNoted initial smoking status and followed whether patients continued to smoke and if so, how much
DietOver six months of studyPerformed MEDFICTs dietary assessment at study start and at study completion, roughly 6 months later
ExerciseOver 6 months of studyPerformed PASE exercise survey at study start and at study completion.
Weightover 6 month studyMeasured weight at study start and at study completion
Blood Pressureover 6 months of studyMeasured blood pressure at study start and at study completion.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026