PLATFORM to Maximize Patient Knowledge of Health Goals After Acute Myocardial Infarction
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|ClinicalTrials.gov Identifier: NCT01807208|
Recruitment Status : Completed
First Posted : March 8, 2013
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Other: Educational Tool||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||PLATFORM to Maximize Patient Knowledge of Health Goals After Acute Myocardial Infarction|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Educational tool
Patients randomized to the educational tool arm of the study will receive mailed educational materials at 1 week post hospital discharge and again at 3 months after discharge.
Other: Educational Tool
A personalized health goal education and reminder tool, with 3 parts: "report card" showing the status of secondary prevention domains during hospitalization; questions to help prepare the patient for the follow-up visit; and potential questions for the physician.
No Intervention: Usual care
Patients in this arm of the study will receive usual care.
- Change in the effect of patient health goal and reminder tool on health outcomes [ Time Frame: baseline, 6 months ]The study team plans to evaluate the impact of a personalized patient health goal education and reminder tool on 6-month clinical and other health outcomes. The measure will be a composite of lab measures (such as blood pressure at goal; BMI at goal), behavior change (physical activity, smoking cessation) and medication use (beta blockers, angiotensin-converting enzyme inhibitors (ACEI)/ angiotensin receptor blockers (ARBs), statins if not contraindicated)
- Satisfaction and usefulness of education tools [ Time Frame: 6 months ]The study team will ask patients whether they used the education tools in their follow-up physician visits post-AMI; how helpful the tools were; whether they were easy to read and understand; and whether the amount of material presented was appropriate
- Age-associated changes that modulate antiplatelet response [ Time Frame: index hospitalization (average 3-5 days), 6 months post discharge ]Describe the physical and functional changes (inflammation, functional decline, nutrition and depression) that modulate platelet inhibitory response to anti-platelet medications
- Association between antiplatelet response and subsequent bleeding events [ Time Frame: 6 months ]Explore the association between antiplatelet response and subsequent bleeding events (number and location of bleeds) among AMI patients to optimize risk stratification and individualize treatment using clinical, physical function and laboratory data
- Age-associated variation in platelet inhibitory response [ Time Frame: index hospitalization (average 3-5 days) ]To examine blood biomarkers of platelet inhibitory response and variability in these biomarkers between younger (less than or equal to 70 years of age) and older patients (over 70 years)
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): NCT01807208
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27715|
|Study Chair:||Eric Peterson, MD, MPH||Duke University|