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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 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: March 17, 2014
Last verified: March 2014

February 28, 2013
March 17, 2014
March 2013
July 2014   (final data collection date for primary outcome measure)
  • 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
  • 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, ACEI/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
Complete list of historical versions of study NCT01807208 on ClinicalTrials.gov Archive Site
  • 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 clopidogrel
  • 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)
Same as current
Not Provided
Not Provided
 
PLATFORM to Maximize Patient Knowledge of Health Goals After Acute Myocardial Infarction
PLATFORM to Maximize Patient Knowledge of Health Goals After Acute Myocardial Infarction

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.

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 200 AMI patients, with at least half over age 65 years, treated with antiplatelet therapy at the time of enrollment. 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. Four - six weeks after hospital discharge: 100 randomized patients and their outpatient providers will receive a evaluate the impact of a personalized post-AMI health goal education and reminder tool on patient adherence to evidence-based secondary prevention therapies and long-term clinical outcomes. Data will be analyzed in aggregate using descriptive statistics. The primary endpoint of interest is a composite measure of at six months adherence 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Acute Myocardial Infarction
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.
  • Experimental: Educational tool
    Patients randomized to the educational tool arm of the study will receive mailed educational materials at 2 weeks post hospital discharge and again at 4 months after discharge.
    Intervention: Other: Educational Tool
  • No Intervention: Usual care
    Patients in this arm of the study will receive usual care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
January 2015
July 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Rob Mathews, MD 919-668-8135 robin.mathews@dm.duke.edu
Contact: Laura Webb, BS 919-668-8977 laura.webb@duke.edu
United States
 
NCT01807208
Pro00034650, 5U19HS021092
No
Duke University
Duke University
  • Gilead Sciences
  • Agency for Healthcare Research and Quality (AHRQ)
Study Chair: Eric Peterson, MD, MPH Duke University
Duke University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP