Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Patient-Centered Adherence Intervention After Acute Coronary Syndrome (ACS) Hospitalization (MEDICATION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00903032
First received: May 13, 2009
Last updated: January 8, 2015
Last verified: January 2015
Results First Received: December 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Acute Coronary Syndrome
Interventions: Behavioral: Intervention
Behavioral: Usual care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Patient Centered Intervention

The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.

Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of re

Usual Care

Patients will receive usual care following ACS hospital discharge

Usual care: Usual care following ACS hospital discharge.


Participant Flow:   Overall Study
    Patient Centered Intervention     Usual Care  
STARTED     129     124  
COMPLETED     122     119  
NOT COMPLETED     7     5  
Withdrawal by Subject                 5                 3  
Lost to Follow-up                 2                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Patient Centered Intervention The multi-faceted patient centered intervention adapts elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, PCPs, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens, and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs. Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.
Usual Care

Patients will receive usual care following ACS hospital discharge

Usual care: Usual care following ACS hospital discharge.

Total Total of all reporting groups

Baseline Measures
    Patient Centered Intervention     Usual Care     Total  
Number of Participants  
[units: participants]
  122     119     241  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     77     73     150  
>=65 years     45     46     91  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 8.57     63.8  ± 9.25     64  ± 9  
Gender  
[units: participants]
     
Female     2     3     5  
Male     120     116     236  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     3     7     10  
Not Hispanic or Latino     86     84     170  
Unknown or Not Reported     33     28     61  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     3     3  
Asian     9     12     21  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     17     12     29  
White     92     78     170  
More than one race     0     0     0  
Unknown or Not Reported     4     14     18  
Region of Enrollment  
[units: participants]
     
United States     122     119     241  



  Outcome Measures

1.  Primary:   Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB)   [ Time Frame: 12-months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: P. Michael Ho
Organization: VA ECHCS
phone: 720-857-5115
e-mail: Michael.Ho@va.gov


Publications of Results:
Other Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00903032     History of Changes
Other Study ID Numbers: IIR 08-302
Study First Received: May 13, 2009
Results First Received: December 3, 2014
Last Updated: January 8, 2015
Health Authority: United States: Federal Government