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

NCT00308386 | Completed Phase 3 DMC

• 2 other identifiers: R18 67495 (completed)R18DK067495
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus; Hypertension; Hyperlipidemia

Keywords

Nurse Case Management; Diabetes; Hypertension; Hyperlipidemia; Behavior therapy; Motivational interviewing

Outcome Measures

Primary Outcomes (4)

• % of patients reaching goal HbA1C (<7)

  2 years after enrollment

• % of patients with BP goal (<130/80)

  Two years after enrollment

• % of patients with LDL at goal (<100)

  2 years after enrollment

• % of patients at goal for all three parameters (HbA1C <7, BP <130/80, LDL <100)

  2 years after enrollment

Secondary Outcomes (13)

• % of patients with yearly ophthalmologic exam

  2 years after enrollment

• % of patients with yearly foot exam

  2 years after enrollment

• % of patients with assessment for nephropathy

  2 years after enrollment

• % of patients with nephropathy on ACE inhibitor or ARB

  2 years after enrollment

• % of patients on aspirin

  2 years after enrollment

Interventions

Nurse Case Management intervention BEHAVIORAL

Intervention is meeting with nurse case managers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Reading Hospital

Reading, Pennsylvania, 19612, United States

Location

Related Publications (2)

• Gabbay RA, Lendel I, Saleem TM, Shaeffer G, Adelman AM, Mauger DT, Collins M, Polomano RC. Nurse case management improves blood pressure, emotional distress and diabetes complication screening. Diabetes Res Clin Pract. 2006 Jan;71(1):28-35. doi: 10.1016/j.diabres.2005.05.002. Epub 2005 Jul 12.

  PMID: 16019102 BACKGROUND

• Stuckey HL, Dellasega C, Graber NJ, Mauger DT, Lendel I, Gabbay RA. Diabetes nurse case management and motivational interviewing for change (DYNAMIC): study design and baseline characteristics in the Chronic Care Model for type 2 diabetes. Contemp Clin Trials. 2009 Jul;30(4):366-74. doi: 10.1016/j.cct.2009.03.002. Epub 2009 Mar 26.

  PMID: 19328244 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Hyperlipidemias

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Robert Gabbay, MD, PhD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2006
• First Posted: March 29, 2006
• Study Start: August 10, 2006
• Primary Completion: July 27, 2011
• Study Completion: July 27, 2011
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

US (2)