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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Milton S. Hershey Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00308386
First received: March 27, 2006
Last updated: February 28, 2011
Last verified: February 2011
  Purpose

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 evaluate clinical response (improvements in A1C, BP, LDL, and depression when present) as well as a series of other measures that will be obtained by surveys (patient satisfaction, quality of life, self-management behaviors). Provider satisfaction will be measured using a standardized tool. Finally, cost effectiveness of the intervention and evaluation of the potential barriers to implementation will be studied.


Condition Intervention Phase
Diabetes Mellitus
Hypertension
Hyperlipidemia
Behavioral: Nurse Case Management intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Nurse Case Management on Diabetes Co-morbidities

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • % of patients reaching goal HbA1C (<7) [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]
  • % of patients with BP goal (<130/80) [ Time Frame: Two years after enrollment ] [ Designated as safety issue: No ]
  • % of patients with LDL at goal (<100) [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]
  • % of patients at goal for all three parameters (HbA1C <7, BP <130/80, LDL <100) [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • % of patients with yearly ophthalmologic exam [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]
  • % of patients with yearly foot exam [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]
  • % of patients with assessment for nephropathy [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]
  • % of patients with nephropathy on ACE inhibitor or ARB [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]
  • % of patients on aspirin [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]
  • % of patients at or above CES-D depression score 16 for severe depression [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]
  • Change in weight [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]
  • Emotional distress (PAID survey) [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]
  • Diabetes specific quality of life (ADD QOL) [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]
  • Diabetes self care activities survey [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]
  • Patient satisfaction survey (DTSQ) [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]
  • Costs and cost-effectiveness [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]
  • Physician satisfaction - survey filled out by physician [ Time Frame: 2 years after enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 820
Study Start Date: August 2006
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Nurse Case Management intervention
    Intervention is meeting with nurse case managers
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • age > 18 years old who are at high risk based on any one of the following criteria:

    • HbA1C > 8.5
    • LDL > 130
    • BP > 140/90 within the last 6 months

Exclusion Criteria:

  • patients who are pregnant upon entry in the study (however if a patient becomes pregnant in the course of the study, she can continue with the study)
  • unable to communicate in either English or Spanish
  • in nursing homes (and therefore unable to attend outpatient visits)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308386

Locations
United States, Pennsylvania
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
Reading Hospital
Reading, Pennsylvania, United States, 19612
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Robert Gabbay, MD, PhD Penn State College of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Gabbay, MD, Phd., Penn State University College of Medicine
ClinicalTrials.gov Identifier: NCT00308386     History of Changes
Other Study ID Numbers: R18 67495 (completed), R18DK067495
Study First Received: March 27, 2006
Last Updated: February 28, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Nurse Case Management
Diabetes
Hypertension
Hyperlipidemia
Behavior therapy
Motivational interviewing

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperlipidemias
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014