NCT00409240

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Oct 2006

Typical duration for phase_3 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

April 11, 2014

Completed
Last Updated

April 11, 2014

Status Verified

March 1, 2014

Enrollment Period

1.7 years

First QC Date

December 7, 2006

Results QC Date

January 14, 2014

Last Update Submit

March 6, 2014

Conditions

DiabetesHypertensionDyslipidemia

Keywords

Group InterventionPharmacotherapyBehavioral ModificationDiabetes

Outcome Measures

Primary Outcomes (1)

  • Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study

    Hemoglobin A1C target was \< 7% LDL cholesterol goal of \< 100mg/dl or \<70mg/dl for patients at high risk-current cardiovascular disease Systolic blood pressure goal of \<130mm Hg

    6 months

Study Arms (2)

MEDIC Intervention

EXPERIMENTAL

Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction

Other: MEDIC

Usual Care

NO INTERVENTION

Patient continued on usual care

Interventions

MEDICOTHER

Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups.

MEDIC Intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence VAMC

Providence, Rhode Island, 02908, United States

Location

Related Publications (1)

  • Cohen LB, Taveira TH, Khatana SA, Dooley AG, Pirraglia PA, Wu WC. Pharmacist-led shared medical appointments for multiple cardiovascular risk reduction in patients with type 2 diabetes. Diabetes Educ. 2011 Nov-Dec;37(6):801-12. doi: 10.1177/0145721711423980. Epub 2011 Oct 21.

    PMID: 22021025RESULT

MeSH Terms

Conditions

Diabetes MellitusHypertensionDyslipidemias

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesLipid Metabolism Disorders

Limitations and Caveats

Only 1 in 5 patients responded to the invitation to join the study and was willing to participate, participants were mostly male veterans, and pharmacists had prescribing privileges in the VA and in this study.

Results Point of Contact

Title
Wen-Chih Wu, MD
Organization
Providence VAMC
wen-chih.wu@va.gov
401-273-7100

Study Officials

  • Wen-Chih Wu, MD

    Providence VAMC, Brown Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Cardiologist

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 8, 2006

Study Start

October 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

April 11, 2014

Results First Posted

April 11, 2014

Record last verified: 2014-03

Locations

US(1)