We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00426231
First Posted: January 24, 2007
Last Update Posted: February 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dhananjay Vaidya, Johns Hopkins University
Results First Submitted: January 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Coronary Arteriosclerosis
Myocardial Infarction
Interventions: Behavioral: Navigation by a health worker
Behavioral: Information control

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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



Responsible Party: Dhananjay Vaidya, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00426231     History of Changes
Other Study ID Numbers: NA_00001948
AHA 0670015N
First Submitted: January 23, 2007
First Posted: January 24, 2007
Results First Submitted: January 13, 2014
Results First Posted: February 24, 2014
Last Update Posted: February 24, 2014