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Culturally-Tailored Approach to Improve Medication Use in Patients With Heart Attacks

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dhananjay Vaidya, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00426231
First received: January 23, 2007
Last updated: January 13, 2014
Last verified: January 2014
Results First Received: January 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Coronary Arteriosclerosis
Myocardial Infarction
Interventions: Behavioral: Navigation by a health worker
Behavioral: Information control

  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
This trial recruited lower income and lower educational level Black and white American patients identified at the time of hospitalization of the Johns Hopkins Medical Institutions for a myocardial infarction, coronary artery bypass graft, or percutaneous intervention.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were enrolled during their hospitalization. Participants had their randomization visit at 1 month.

Reporting Groups
  Description
Patient Navigator Intervention

Patient Navigator intervention

Navigation by a health worker : Help provided by health worker to navigate medication access programs

Information Control

Information control

Information control : Information about medication access programs provided to the participant and their healthcare provider


Participant Flow:   Overall Study
    Patient Navigator Intervention     Information Control  
STARTED     36     37  
COMPLETED     27 [1]   25 [2]
NOT COMPLETED     9     12  
Withdrawal by Subject                 9                 12  
[1] For the 6 month endpoint
[2] For the 6-month endpoint



  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.
No text entered.

Reporting Groups
  Description
Patient Navigator Intervention

Patient Navigator intervention

Navigation by a health worker : Help provided by health worker to navigate medication access programs

Information Control

Information control

Information control : Information about medication access programs provided to the participant and their healthcare provider

Total Total of all reporting groups

Baseline Measures
    Patient Navigator Intervention     Information Control     Total  
Number of Participants  
[units: participants]
  36     37     73  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     27     31     58  
>=65 years     9     6     15  
Age  
[units: years]
Mean ± Standard Deviation
  55.2  ± 11.0     55.8  ± 10.2     55.5  ± 10.6  
Gender  
[units: participants]
     
Female     16     16     32  
Male     20     21     41  
Region of Enrollment  
[units: participants]
     
United States     36     37     73  



  Outcome Measures
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1.  Primary:   Achievement of LDL-cholesterol Goals   [ Time Frame: 6 months ]

2.  Secondary:   Self-reported Medication Adherence   [ Time Frame: 6 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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dhananjay Vaidya
Organization: Johns Hopkins University
phone: 410-6142307
e-mail: dvaidya1@jhmi.edu


No publications provided


Responsible Party: Dhananjay Vaidya, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00426231     History of Changes
Other Study ID Numbers: NA_00001948, AHA 0670015N
Study First Received: January 23, 2007
Results First Received: January 13, 2014
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board