Evaluation of Diabetes Self-Management Consultant Care

National Institutes of Health (NIH)

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Diabetes Self-Management Consultant; Behavioral: Enhanced Usual Care Control Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00109720

62323 (completed)

Details and patient eligibility

About

The purpose of this study is to find out if Self-Management Consultant (SMC) intervention will be more effective than usual care in improving blood glucose control and diabetes-related quality of life for adults with type 2 diabetes.

Full description

This study is designed to compare the effectiveness of a diabetes Self-Management Consultant (SMC) intervention for adults with type 2 diabetes with unsatisfactory glucose control (i.e., HbA1c ≥ 8%--the value chosen as "high risk" by the Diabetes Quality Improvement Project which is an initiative of the Health Care Financing Administration, the American Diabetes Association, and the Foundation for Accountability) to a control group selected using the same criteria. The SMC intervention will be implemented and evaluated in two different health care systems serving two distinct populations of patients with diabetes. After signing the Informed Consent document, subjects will be randomized to the SMC intervention or a control group. All subjects in the study will complete a baseline assessment of their diabetes care and health status.

Subjects randomized to the SMC intervention will have an individual meeting with the SMC to review and refine a self-management plan based on the subject's priorities and goals. These subjects will receive individual follow-up and support during the year, through monthly phone calls and an annual meeting with the SMC and their primary care physician. Subjects randomized to the control group will receive usual care following their baseline and their 12-, 24-, and 36-month assessments. Unlike most nurse-manager studies, the SMC's interactions with patient care will use a theory-based behavioral approach with which we have extensive experience. The study is designed to evaluate the effectiveness of the SMC intervention compared to usual care.

All records will be handled confidentially. Lab results and personal data will be linked by a research specific identifier code.

Enrollment: 310 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults over age 21 diagnosed with type 2 diabetes for at least one year.

Exclusion criteria

• Patients under psychiatric care
• Currently pregnant
• Those who have not been diagnosed with type 2 diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

1

Experimental group

Description:

Patients in the experimental group received the services of a Diabetes Self-Management Consultant (DSC)

Treatment:

Behavioral: Diabetes Self-Management Consultant

2

Active Comparator group

Description:

This Arm was a Enhanced Usual Care Control group who continued with their usual care but also they and their physicians received the results of all metabolic assessments obtained during the study.

Treatment:

Behavioral: Enhanced Usual Care Control Group