PLATFORM to Maximize Patient Knowledge of Health Goals After Acute Myocardial Infarction

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Duke University
Sponsor:
Collaborators:
Gilead Sciences
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01807208
First received: February 28, 2013
Last updated: October 1, 2014
Last verified: September 2014
  Purpose

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 Intervention
Acute Myocardial Infarction
Other: Educational Tool

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: PLATFORM to Maximize Patient Knowledge of Health Goals After Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in the effect of patient health goal and reminder tool on health outcomes [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Age-associated changes that modulate antiplatelet response [ Time Frame: index hospitalization (average 3-5 days), 6 months post discharge ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 220
Study Start Date: March 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807208

Contacts
Contact: Rob Mathews, MD 919-668-8135 robin.mathews@dm.duke.edu
Contact: Laura Webb, BS 919-668-8977 laura.webb@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27715
Contact: Laura Webb    919-668-8977    laura.webb@duke.edu   
Principal Investigator: Tracy Wang, MD         
Sponsors and Collaborators
Duke University
Gilead Sciences
Investigators
Study Chair: Eric Peterson, MD, MPH Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01807208     History of Changes
Other Study ID Numbers: Pro00034650, 5U19HS021092
Study First Received: February 28, 2013
Last Updated: October 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Acute myocardial infarction
patient education
prevention

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

ClinicalTrials.gov processed this record on October 19, 2014