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Cholesterol Medication Packaging Study (MWV_CAPS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT01744977
First received: December 5, 2012
Last updated: April 12, 2016
Last verified: April 2016
Results First Received: March 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Hypercholesterolemia
Intervention: Behavioral: packaging

  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
Adherence Packaging Intervention Group

[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA (Research Assistant) on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.

packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles

Education Only Group Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.

Participant Flow:   Overall Study
    Adherence Packaging Intervention Group   Education Only Group
STARTED   120   120 
6 Month Completed   113   115 
COMPLETED   109   115 
NOT COMPLETED   11   5 
Withdrawal by Subject                1                2 
Death                2                3 
Lost to Follow-up                2                0 
No longer meets inclusion                6                0 



  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
Adherence Packaging Intervention Group

[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.

packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles

Education Only Group Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
Total Total of all reporting groups

Baseline Measures
   Adherence Packaging Intervention Group   Education Only Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 120   120   240 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.4  (8.9)   62.9  (8.6)   62.6  (8.7) 
Gender 
[Units: Participants]
     
Female   11   10   21 
Male   109   110   219 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   47   41   88 
African American or Other   73   79   152 
Region of Enrollment 
[Units: Participants]
     
United States   120   120   240 


  Outcome Measures
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1.  Primary:   Cholesterol Medication Adherence   [ Time Frame: 12 months ]

2.  Secondary:   Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months   [ Time Frame: Baseline, 6months, 12months ]


  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: Hayden Bosworth, PhD
Organization: Durham Veterans Affairs Medical Center
phone: 919-286-6936
e-mail: hayden.bosworth@va.gov



Responsible Party: Durham VA Medical Center
ClinicalTrials.gov Identifier: NCT01744977     History of Changes
Other Study ID Numbers: 01642
Study First Received: December 5, 2012
Results First Received: March 11, 2016
Last Updated: April 12, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government