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N/A N=4,622 Randomized Treatment

Adherence and Intensification of Medications (AIM) Implementation Study

Diabetes · Hypertension

Enrolled (actual)
4,622
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Change in Systolic Blood Pressure — -8.9; -9.0 mmHg

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Clinical pharmacist-based intervention (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
US Department of Veterans Affairs
Primary completion
Mar 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Systolic Blood Pressure
-8.9; -9.0
SECONDARY
A1c Control
7.4; 7.6
SECONDARY
LDL Control
89.1; 87.8

Summary

Background: Good blood pressure (BP) control among patients with diabetes is essential in preventing diabetes complications and has been found to be not only cost-effective but cost-saving. Nonetheless, over 25% of VA patients with diabetes do not have adequate BP control. Among these poorly controlled patients, over 65% have problems with medication adherence or inadequate intensification of medications. We therefore propose a partnership with the VA Pharmacy Benefits Management (PBM) Office and VISN 11 to evaluate a tailored clinical pharmacist-based intervention to improve medication management, adherence and BP control. Objectives: The specific objectives of this implementation study are: 1) To evaluate the effects of the intervention on blood pressure (primary outcome) and glycemic and lipid control (secondary outcomes); 2) To assess the impact of the intervention on patients' adherence to blood pressure, anti-hyperglycemic, and lipid-lowering regimens, and intensity of these regimens; 3) To evaluate the cost-effectiveness of the intervention compared to usual care; 4) To evaluate the level of attainment of intervention implementation, examine the process of intervention implementation, and determine the potential for sustainability.

Eligibility Criteria

Inclusion Criteria

VA inclusion criteria

  • Must be a veteran at a study site;
  • Have a diagnosis of diabetes;
  • Meet blood pressure, medication adherence and intensification requirements (as determined by the study team)

Exclusion Criteria

VA Exclusion

  • Dementia
  • Traumatic brain injury
  • Pregnancy
  • Age 100
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00495794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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