Phase 3 N=103 Randomized Treatment

Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes

Diabetes · Hypertension · Dyslipidemia

Bottom Line

View on ClinicalTrials.gov: NCT00409240 ↗

Enrolled (actual)

103

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcome: Primary: Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study — 40.8; 20.4; 82.0; 65.3 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: MEDIC (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Providence VA Medical Center
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study	40.8; 20.4; 82.0; 65.3; 58.0; 32.7	—

Summary

Our study intends to test the efficacy of pharmacist-led group interventions on a weekly basis for 4-weeks, then on a monthly basis for 5 additional months to achieve concomitant reductions in hemoglobin A1c, lipids and blood pressure.

Eligibility Criteria

Inclusion Criteria

type 2 diabetes mellitus,
>18 years old,
with a documented HbA1c more than 7.0%,
an LDL cholesterol >100 mg/dl AND a blood pressure >130/80 mm Hg documented at least once in the medical records within the last 6 months, and
willing to comply with the study interventions will be eligible for the study.

Exclusion Criteria

pregnancy,
unable to attend the group sessions,
disease conditions such as psychiatric instability (acutely suicidal, psychotic) or organic brain injury that preclude them from performing diabetes self-care,
enrolled in the Providence VAMC's Telehealth program

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00409240). 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.