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Adherence and Intensification of Medications (AIM) Implementation Study

This study has been completed.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Kaiser Permanente
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00495794
First received: June 29, 2007
Last updated: April 6, 2015
Last verified: July 2014
Results First Received: September 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Hypertension
Intervention: Behavioral: Clinical pharmacist-based intervention

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pharmacist Management

Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)

Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms

Usual Care Eligible patients receive usual care

Participant Flow:   Overall Study
    Pharmacist Management   Usual Care
STARTED   2319   2303 
COMPLETED   1797   2303 
NOT COMPLETED   522   0 
Pharmacist did not activate patient                522                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
Pharmacist Management

Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)

Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms

Usual Care Eligible patients receive usual care
Total Total of all reporting groups

Baseline Measures
   Pharmacist Management   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 1797   2303   4100 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.3  (11.7)   65.3  (12.1)   65.3  (11.9) 
Gender 
[Units: Participants]
     
Female   547   721   1268 
Male   1250   1582   2832 
Region of Enrollment 
[Units: Participants]
     
United States   1797   2303   4100 


  Outcome Measures
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1.  Primary:   Change in Systolic Blood Pressure   [ Time Frame: 6 months prior to 6 months after the intervention period ]

2.  Secondary:   A1c Control   [ Time Frame: 12 months after intervention period ]

3.  Secondary:   LDL Control   [ Time Frame: 12 months after invention period ]


  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
In the intervention arm, only 53% of subjects had a pharmacist encounter. Higher rates of participation might have led to a more substantial initial improvement and a detectable longer term effect.


  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: Dr. Michele Heisler
Organization: VA Center for Clinical Management Research; University of Michigan
phone: 734-845-3504
e-mail: mheisler@umich.edu


Publications of Results:


Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00495794     History of Changes
Other Study ID Numbers: SDP 06-128
R18DK076622-01 ( US NIH Grant/Contract Award Number )
Study First Received: June 29, 2007
Results First Received: September 3, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government