N/A
N=4,622
Adherence and Intensification of Medications (AIM) Implementation Study
Diabetes · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00495794 ↗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
| Outcome | Result | p-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
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.