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NCT00308386 · ClinicalTrials.gov registry record · Phase 3

DYNAMIC Study: (Diabetes Nurse Case Management And Motivational Interviewing for Change)

A Phase 3 study, sponsored by Milton S. Hershey Medical Center.

Completed
Registry status
Phase 3
Development phase
550
Enrollment target

NCT00308386 is a Phase 3 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 550 participants.

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The verdict

NCT00308386, a Phase 3 study, has completed, sponsored by Milton S. Hershey Medical Center.

COMPLETED
Registry status
Phase 3
Development phase
550 participants
Enrollment target

Study Summary

Although strong clinical evidence exists that patients with diabetes should achieve certain clinical goals (i.e. HbA1C, BP, LDL, etc.), to reduce morbidity and mortality national surveys indicate that only a minority of people with diabetes achieves these goals. Hypothesis: combination of nurse case management and enhanced behavior change counseling will improve outcomes for glycemic control, blood pressure and cholesterol in high risk patients with Type 2 diabetes when compared to usual care over a 3 year period. Study design- The study will be a three year randomized control trial that will select patients that have either A1C \>8.5, LDL \>130, or BP \>140/90. Nurse case managers, trained in clinical guidelines and brief behavior change counseling techniques (motivational interviewing), will aim to foster patient adherence in the experimental group patients. Nurse case managers will use standing orders to set an implementation of clinical guidelines (for diabetes, hypertension, hyperlipidemia and depression) with individual follow up. A total of 820 patients between the all 9 (6 Hershey Medical Center and 3 Reading Hospital affiliated clinics) will be sought. One third of the study patients will be recruited from the underserved Hispanic population in the Reading area. Patients will be randomized by physician i.e. one physician will be randomly assigned to have all their patients co-managed by a nurse case manager; the other will have usual care without any contact with nurse case manager. Nurses will be trained and then initiate a small pilot study in July thru August. Full recruitment and initiation of study will begin in September 2006. Clinic Activities - Each nurse will be responsible for 3 clinics. Nurses will work under the supervision of the primary care physicians. A set of clinical guidelines will be developed with physician input that will serve as the over-riding framework for the nurses. Outcomes - Over a three-year period the investigators will

Interventions

  • BEHAVIORAL Nurse Case Management intervention

Trial Details

FieldValue
Enrollment Target 550 participants
Start Date 2006-08-10
Est. Completion 2011-07-27
Phase Phase 3

Sponsor

Milton S. Hershey Medical Center

396 total trials

What the Registry Record Tells You About NCT00308386

The ClinicalTrials.gov registry entry for NCT00308386 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 550 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Nurse Case Management intervention is the first listed.

NCT00308386 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00308386 about?

NCT00308386 is a clinical study titled "DYNAMIC Study: (Diabetes Nurse Case Management And Motivational Interviewing for Change)". Although strong clinical evidence exists that patients with diabetes should achieve certain clinical goals (i.e. HbA1C, BP, LDL, etc.), to reduce morbidity and mortality national surveys indicate that only a minority of people with diabetes achieves these goals. Hypothesis: combination of nurse cas...

What is the current status of trial NCT00308386?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 550 participants. The study started on 2006-08-10. Estimated completion is 2011-07-27.

What interventions are being tested in trial NCT00308386?

The interventions under investigation include: Nurse Case Management intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT00308386?

This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.