Duke University Medical Center
Durham, North Carolina, 27715, United States
NCT Number: NCT01807208
The goals of this study are two fold: 1) To learn whether a personalized patient health goal and reminder tool helps patients to learn more about their condition and to make changes in behavior and medication taking to reduce the risk of another heart attack. 2) To examine a blood sample to learn how patients are responding to their medications. The study team will enroll approximately 220 patients in the hospital recovering from a heart attack. Half of the patients will receive the educational tools and a copy will be sent to their outpatient provider.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27715, United States
The goals of this study are two fold: 1) To evaluate the impact of a personalized patient health goal education and reminder tool on patient adherence to evidence based therapies and subsequent cardiovascular risk factor modification after acute myocardial infarction (AMI); 2) To assess age-related heterogeneity in antiplatelet response among AMI patients. This is a prospective study of ~220 AMI patients, with at least half over age 65 years. Patients will be surveyed with questionnaires (at baseline and 6 months post discharge) and biomarkers (baseline only) to assess the status of their physical function, depression, nutrition, inflammation, and response to antiplatelet therapies. Patients will also be administered a walking test and a grip strength test at baseline. About 1 week after hospital discharge, and again about 3 months after hospital discharge, about half of the patients and their outpatient providers will receive the personalized post-AMI health goal education and reminder tool on patient adherence to evidence-based secondary prevention therapies. Data will be analyzed in aggregate using descriptive statistics. The primary endpoint of interest is a composite measure of adherence at six months to secondary prevention therapies described as the sum of measures received divided by the sum of available opportunities. The secondary endpoint will be analyzed to describe platelet response profiles as a function of age. The study team anticipates the risks for this study to be minimal, since the patient does not receive any investigational therapies.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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)
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
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
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
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)
Duke University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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