NCT00012662

Brief Summary

Social, medical and economic burdens of diabetes care result from microvascular, macrovascular and neurological complications. Sustained reduction in hyperglycemia can reduce the incidence of these complications by as much as 50 percent. Studies have demonstrated improved glycemic control with nurse case-management or educational care models. However, none have controlled for their independent contributions, intervened with advanced practice nurses (APN), or targeted highest risk individuals.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

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

First Submitted

Initial submission to the registry

March 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2001

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
Last Updated

April 7, 2015

Status Verified

February 1, 2007

First QC Date

March 14, 2001

Last Update Submit

April 6, 2015

Conditions

Diabetes Mellitus Self Management EducationHyperglycemic ControlHigh Risk Diabetes

Study Arms (1)

Arm 1

OTHER
Behavioral: Diabetes Self Management Education

Interventions

Diabetes Self Management EducationBEHAVIORAL
Arm 1

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes HbA1C. 9.0%, consistent diabetes tx over last 3 months.

You may not qualify if:

  • Homelessness-not able to be consistently contacted; Dementia, Planned Movement from area; Unstable angina, Myocardial Infarction in past 3 months; Stroke; Two or more seizures in last 3 months; document alcoholism or drug abuse; Pregnant or planning to become pregnant in next 12 months; Severe immunodeficiency or cirrhosis of the liver; Type 1 diabetes; blind individuals; psychosis; pancreatitis with secondary diabetes; Renal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Atlanta, Kansas, 21201, United States

Location

Related Publications (1)

  • Bradham DD, Mangan M, Warrick A, Geiger-Brown J, Reiner JI, Saunders HJ. Linking innovative nursing practice to health services research. Nurs Clin North Am. 2000 Jun;35(2):557-68.

    PMID: 10873268RESULT

Study Officials

  • Bruce P. Hamilton, MD

    Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Completion

December 1, 2002

Last Updated

April 7, 2015

Record last verified: 2007-02

Locations

US(1)