NCT00357955

Brief Summary

The purpose of this research is to study whether a multidisciplinary education in Diabetes and intervention for cardiac risk reduction in a group setting to modify patient behavior and adjust medications can achieve diabetes guideline goals for glycemia, blood pressure and lipid control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Aug 2004

Longer than P75 for not_applicable 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

August 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
6 years until next milestone

Results Posted

Study results publicly available

May 13, 2014

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

3.8 years

First QC Date

July 24, 2006

Results QC Date

January 14, 2014

Last Update Submit

November 5, 2024

Conditions

DiabetesHypertensionDyslipidemiaCoronary Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg

    The major outcome was the percentage of participants who attain the target goals for A1C, blood pressure,and ldl cholesterol lipids set by the American Diabetes Association guidelines, defined as A1C \<7%, SBP \<130 mm Hg, diastolic blood pressure (DBP) \<80 mm Hg, and LDL cholesterol \<100 mg/dL (2.6 mmol/L).

    4 months

Study Arms (2)

MEDIC

EXPERIMENTAL

Multidisciplinary education and diabetes intervention for cardiac risk reduction

Behavioral: Behavioral counseling and peer supportBehavioral: Interactive EducationBehavioral: Role modelingProcedure: Pharmacologic case management

usual care

NO INTERVENTION

usual care

Interventions

Behavioral counseling and peer supportBEHAVIORAL

Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention

MEDIC
Interactive EducationBEHAVIORAL

interactive lectures with hands-on learning

MEDIC
Role modelingBEHAVIORAL

learning from peers with similar disease and problems

MEDIC
Pharmacologic case managementPROCEDURE

provided by clinical pharmacists following pre-established algorithms

MEDIC

Eligibility Criteria

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

You may qualify if:

  • All diabetic veterans with a Hb-A1c between 7.0- 9.0 % within the last 6 months will be eligible for the study

You may not qualify if:

  • Patients without an Hb-A1c checked within the last 6 months.
  • Patients who are unable to attend the group sessions, either because of lack of transportation, psychiatric instability (suicidal, psychotic), or organic brain injury that preclude them from diabetes self-care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence VAMC

Providence, Rhode Island, 02908, United States

Location

Related Publications (2)

  • Taveira TH, Friedmann PD, Cohen LB, Dooley AG, Khatana SA, Pirraglia PA, Wu WC. Pharmacist-led group medical appointment model in type 2 diabetes. Diabetes Educ. 2010 Jan-Feb;36(1):109-17. doi: 10.1177/0145721709352383. Epub 2009 Dec 4.

    PMID: 19966072RESULT

  • Khatana SA, Taveira TH, Choudhary G, Eaton CB, Wu WC. Change in hemoglobin A(1c) and C-reactive protein levels in patients with diabetes mellitus. J Cardiometab Syndr. 2009 Spring;4(2):76-80. doi: 10.1111/j.1559-4572.2008.00042.x.

    PMID: 19614793DERIVED

MeSH Terms

Conditions

Diabetes MellitusHypertensionDyslipidemiasCoronary Artery Disease

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Wen-Chih Wu, MD; Principal Investigator
Organization
Providence VA Medical Center
wen-chih.wu@va.gov
4012737100

Study Officials

  • Wen-Chih Wu, MD

    Providence VAMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
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

July 24, 2006

First Posted

July 28, 2006

Study Start

August 1, 2004

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

November 7, 2024

Results First Posted

May 13, 2014

Record last verified: 2024-11

Locations

US(1)