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Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes

P

Providence VA Medical Center

Status and phase

Completed
Phase 3

Conditions

Hypertension
Diabetes
Dyslipidemia

Treatments

Other: MEDIC

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00409240
1127912

Details and patient eligibility

About

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.

Full description

Our project intends to study the 6-month efficacy of a pharmacist-led group intervention program that simultaneously target diabetes, hypertension and dyslipidemia. We hypothesize that pharmacist-led group interventions on a weekly basis for 4-weeks then on a monthly basis for 5 additional months may achieve concomitant reductions in hemoglobin A1c, lipids and blood pressure. We are proposing a pilot randomized controlled study to test the efficacy and feasibility of this approach.

Enrollment

103 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

103 participants in 2 patient groups

MEDIC Intervention
Experimental group
Description:
Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction
Treatment:
Other: MEDIC
Usual Care
No Intervention group
Description:
Patient continued on usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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