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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
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Myocardial Infarction Other: Educational Tool

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: PLATFORM to Maximize Patient Knowledge of Health Goals After Acute Myocardial Infarction
Study Start Date : March 2013
Primary Completion Date : January 2016
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. 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)

  2. 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

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with either ST-elevation MI (STEMI) or non-ST-elevation MI (NSTEMI) who are on antiplatelet therapy at the time of enrollment.
  2. English language literacy and
  3. Able to provide written informed consent.

Exclusion Criteria:

  1. Patients less than 18 years of age.
  2. Patients who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements
  3. Life expectancy less than 6 months or discharged on hospice care.
  4. Patients without at least 1 scheduled outpatient follow-up visit inside the Duke University Affiliated Physicians network.
  5. Patients who receive a coronary artery bypass grafting (CABG) during the eligible enrollment hospitalization.
  6. Active chronic inflammatory conditions (e.g., inflammatory bowel disease, lupus, rheumatoid arthritis)
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
Duke University
Gilead Sciences
Agency for Healthcare Research and Quality (AHRQ)
Study Chair: Eric Peterson, MD, MPH Duke University
More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01807208     History of Changes
Other Study ID Numbers: Pro00034650
5U19HS021092 ( U.S. AHRQ Grant/Contract )
First Posted: March 8, 2013    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Duke University:
Acute myocardial infarction
patient education

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases