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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00072891
Other study ID # 59048DK (completed)
Secondary ID
Status Completed
Phase N/A
First received November 12, 2003
Last updated February 12, 2010
Est. completion date December 2005

Study information

Verified date February 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study is designed to study how adults with Type 2 Diabetes and either high blood pressure and/or high blood cholesterol manage their treatment regimen. It is also called the Diabetes Management Study. Individuals need to be 40 years of age or older and on oral medication (pills) management for two of the three conditions of interest. They may also be on other treatment such as insulin, diet and/or exercise programs. Individuals will be followed for approximately 12 months. About 1/4 of the persons in the study will receive a telephone counseling program with a nurse focused upon their management of their treatment program.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility - Type 2 diabetes mellitus, hypertension and/or hyperlipidemia,

- On oral medication for two of the above conditions,

- Manage own medications,

- Must have access to a telephone,

- Not participating in other adherence education or counseling trials

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Intervention

Behavioral:
telephone counseling


Locations

Country Name City State
United States University of Pittsburgh School of Nursing Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

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