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TEAMcare for Diabetes in Mental Health Centers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02011529
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : October 5, 2015
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Lydia Chwastiak, University of Washington

Brief Summary:

This proposal aims to demonstrate the feasibility and acceptability of adapting TEAMcare for patients with schizophrenia. The aim of this innovative mental health center-based team intervention is to improve diabetes, cardiovascular and psychiatric outcomes among patients with poorly controlled type 2 diabetes. The study will be conducted in two phases over the 2-year grant period.

Phase 1. Development of the adapted TEAMcare intervention and training of team members.

Phase 2. During year 2, we will implement the intervention on the caseload of 40 outpatients at Harborview Mental Health Services with schizophrenia and poorly controlled type 2 diabetes. The intervention involves the management of subjects' diabetes, hypertension, and hyperlipidemia by a CMHC diabetes team for 6 months (advanced nurse specialist on-site at supervised in weekly meetings by a psychiatrist and a UW Diabetes Center endocrinologist).

The primary aim of this pilot research grant is to evaluate the feasibility of implementing this complex intervention, in order to guide the design of a larger scale efficacy study (R01). Both process and outcome measures will be evaluated at baseline, and at 3- and 6-month follow-up visits for the 40 subjects enrolled in this feasibility trial.

Condition or disease Intervention/treatment Phase
Diabetes Other: TEAMcare treatment of diabetes Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Team Approach to Improve the Quality of Diabetes Care for Patients With Schizophrenia
Study Start Date : November 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Active Comparator: TEAMcare treatment of diabetes Other: TEAMcare treatment of diabetes
TEAMcare is an evidence-based collaborative care approach to the treatment of diabetes and psychiatric illness. It involves structured visits with a study nurse to monitor psychiatric symptoms, control of medical disease, and self-care activities. The nurses use motivational coaching to help patients solve problems and set goals for improved self-care and medication adherence. Medications for diabetes, hypertension, and hyperlipidemia are monitored and therapy intensified based on treat-to-target guidelines. All of these process and outcome measures are tracked in a registry designed for the study, and the nurses receive weekly supervision with a psychiatrist, an endocrinologist and a psychologist in order to review new cases and to track progress. Once a patient achieves targeted levels for relevant measures, the patient and the nurse develop a maintenance plan.

No Intervention: Treatment as usual
Participants randomized to treatment as usual will receive their usual mental health treatment and primary care treatment

Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: 6 months ]
  2. LDL cholesterol [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult (18-70 years);
  • enrolled to receive mental health treatment at Harborview Mental Health Services or Downtown Emergency Services Mental Health center
  • a diagnosis of type 2 diabetes mellitus or cardiovascular disease
  • Hemoglobin A1c >8 or BP > 140/90

Exclusion Criteria:

  • cognitive, hearing, or language impairment that would preclude a subject from providing informed consent;
  • current suicidality, homicidality, or grave disability that requires psychiatric hospitalization;
  • current substance abuse or dependence, as defined by SCID.

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 identifier (NCT number): NCT02011529

United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Lydia Chwastiak, MD, MPH University of Washington

Responsible Party: Lydia Chwastiak, Associate Professor, University of Washington Identifier: NCT02011529     History of Changes
Other Study ID Numbers: 44422-G
R21DK096286-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases