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DYNAMIC Study: (Diabetes Nurse Case Management And Motivational Interviewing for Change)
This study is ongoing, but not recruiting participants.
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00308386
  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 recruied 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 we 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 III

MedlinePlus related topics: Depression Diabetes High Blood Pressure
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Impact of Nurse Case Management on Diabetes co-Morbidities

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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 who are at high risk based on any one of the following criteria: HbA1C >8.5, LDL >130, or 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, or in nursing homes (and therefore unable to attend outpatient visits).
  Contacts and Locations
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
Investigators
Principal Investigator: Robert Gabbay, MD, PhD Penn State College of Medicine
  More Information

Publications:
Responsible Party: Penn State University College of Medicine ( Robert Gabbay, MD, Phd. )
Study ID Numbers: 67495
Study First Received: March 27, 2006
Last Updated: August 19, 2008
ClinicalTrials.gov Identifier: NCT00308386  
Health Authority: United States: Federal Government;   United States: Institutional Review Board

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Nurse Case Management
Diabetes
Hypertension
Hyperlipidemia
Behavior therapy
Motivational interviewing

Study placed in the following topic categories:
Metabolic Diseases
Hyperlipidemias
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Dyslipidemias
Lipid Metabolism Disorders
Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009