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

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ClinicalTrials.gov Identifier: NCT00308386
Recruitment Status : Unknown
Verified February 2011 by Milton S. Hershey Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : March 29, 2006
Last Update Posted : March 1, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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 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 or disease Intervention/treatment Phase
Diabetes Mellitus Hypertension Hyperlipidemia Behavioral: Nurse Case Management intervention Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 820 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Nurse Case Management on Diabetes Co-morbidities
Study Start Date : August 2006
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : August 2010
Arms and Interventions

Intervention Details:
    Behavioral: Nurse Case Management intervention
    Intervention is meeting with nurse case managers

Outcome Measures

Primary Outcome Measures :
  1. % of patients reaching goal HbA1C (<7) [ Time Frame: 2 years after enrollment ]
  2. % of patients with BP goal (<130/80) [ Time Frame: Two years after enrollment ]
  3. % of patients with LDL at goal (<100) [ Time Frame: 2 years after enrollment ]
  4. % of patients at goal for all three parameters (HbA1C <7, BP <130/80, LDL <100) [ Time Frame: 2 years after enrollment ]

Secondary Outcome Measures :
  1. % of patients with yearly ophthalmologic exam [ Time Frame: 2 years after enrollment ]
  2. % of patients with yearly foot exam [ Time Frame: 2 years after enrollment ]
  3. % of patients with assessment for nephropathy [ Time Frame: 2 years after enrollment ]
  4. % of patients with nephropathy on ACE inhibitor or ARB [ Time Frame: 2 years after enrollment ]
  5. % of patients on aspirin [ Time Frame: 2 years after enrollment ]
  6. % of patients at or above CES-D depression score 16 for severe depression [ Time Frame: 2 years after enrollment ]
  7. Change in weight [ Time Frame: 2 years after enrollment ]
  8. Emotional distress (PAID survey) [ Time Frame: 2 years after enrollment ]
  9. Diabetes specific quality of life (ADD QOL) [ Time Frame: 2 years after enrollment ]
  10. Diabetes self care activities survey [ Time Frame: 2 years after enrollment ]
  11. Patient satisfaction survey (DTSQ) [ Time Frame: 2 years after enrollment ]
  12. Costs and cost-effectiveness [ Time Frame: 2 years after enrollment ]
  13. Physician satisfaction - survey filled out by physician [ Time Frame: 2 years after enrollment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Robert Gabbay, MD, PhD Penn State College of Medicine
More Information

Publications:
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 ( U.S. NIH Grant/Contract )
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: March 1, 2011
Last Verified: February 2011

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

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