Coronary Artery DiseaseNCT01083862
Impact of Health Literacy on Outcomes and Effectiveness of Shared Decision Making Programs in Patients With Chronic Diseases
A study testing Educational Intervention - Text plus DVD/VHS and Educational Intervention - Text Only in people with Coronary Artery Disease, run by University of Cincinnati at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 87 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Educational Intervention - Text plus DVD/VHS and Educational Intervention - Text Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18,
- Diagnosis of ischemic heart disease.
Who cannot join
- Nursing home resident,
- Did not speak English, or
- Had a significant visual impairment that precluded their ability to read or watch television.
Trial locations and contacts
1 site in 1 country.
United States1 site
General Internal Medicine Hoxworth Practices
Cincinnati, Ohio, 45267
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Educational Intervention - Text plus DVD/VHS, Educational Intervention - Text Only
- Keywords
- Health literacy, patient education, health behaviors, chronic disease management, shared decision-making, patient-centered decision making
- Medical subject headings
- Coronary Artery Disease, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Intervention - Text plus DVD/VHSBehavioural
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.
Educational Intervention - Text OnlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention - Video & Text | Experimental | Educational Intervention - Video \& Text describing "Living with Coronary Artery Disease." Receives: Behavioral: Educational Intervention - Text plus DVD/VHS |
| Educational Intervention - Text Only | Active comparator | Educational Intervention - Text Only describing "Living with Coronary Artery Disease." Receives: Behavioral: Educational Intervention - Text Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediate and 6 months
Secondary outcomes (5)
Smoking status
Noted initial smoking status and followed whether patients continued to smoke and if so, how much
Measured: over 6 months of study
Diet
Performed MEDFICTs dietary assessment at study start and at study completion, roughly 6 months later
Measured: Over six months of study
Exercise
Performed PASE exercise survey at study start and at study completion.
Measured: Over 6 months of study
Weight
Measured weight at study start and at study completion
Measured: over 6 month study
Blood Pressure
Measured blood pressure at study start and at study completion.
Measured: over 6 months of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startOct 2005
- Primary completionOct 2007
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Informed Medical Decision Making
- Responsible party
- Principal investigator, Mark Eckman, M.D., University of Cincinnati
- Investigators
- Mark H Eckman, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083862
- Sponsor's protocol ID
- FIMDM-CS09052/GR090501
- Status last verified
- Nov 2023
- First submitted
- 5 Mar 2010
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Health Literacy on Outcomes and Effectiveness of Shared Decision Making Programs in Patients With Chronic Diseases
- ClinicalTrials.gov ID
- NCT01083862
- Acronym / sponsor ID
- FIMDM-CS09052/GR090501
- Conditions
- Coronary Artery Disease
- Keywords
- Health literacy, patient education, health behaviors, chronic disease management, shared decision-making, patient-centered decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Foundation for Informed Medical Decision Making
- Study start
- Oct 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention - Video & Text | Experimental | Behavioral: Educational Intervention - Text plus DVD/VHSEducational Intervention - Video \& Text describing "Living with Coronary Artery Disease." |
| Educational Intervention - Text Only | Active comparator | Behavioral: Educational Intervention - Text OnlyEducational Intervention - Text Only describing "Living with Coronary Artery Disease." |
Who may qualify
- Ages
- 18 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >= 18,
- Diagnosis of ischemic heart disease.
Key exclusion criteria (3 listed)
- Nursing home resident,
- Did not speak English, or
- Had a significant visual impairment that precluded their ability to read or watch television.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Intervention - Text plus DVD/VHSIn 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. | Behavioural | Educational Intervention - Video & Text |
| Educational Intervention - Text OnlyIn 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. | Behavioural | Educational Intervention - Text Only |
Primary outcome
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
5 secondary outcomes
Smoking status
Time frame: over 6 months of study
Diet
Time frame: Over six months of study
Exercise
Time frame: Over 6 months of study
Weight
Time frame: over 6 month study
Blood Pressure
Time frame: over 6 months of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark H Eckman, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention - Text plus DVD/VHS and Educational Intervention - Text Only in people with Coronary Artery Disease, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular disease knowledge assessment score (time frame: immediate and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.