TEAMcare for Diabetes in Mental Health Centers

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lydia Chwastiak, University of Washington
ClinicalTrials.gov Identifier:
NCT02011529
First received: December 9, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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 Intervention
Diabetes
Other: TEAMcare treatment of diabetes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Team Approach to Improve the Quality of Diabetes Care for Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • LDL cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult (18-64 years);
  • enrolled to receive mental health treatment at Harborview Mental Health Services
  • meet DSM-IV criteria for schizophrenia, or schizoaffective disorder, based on SCID interview
  • a diagnosis of type 2 diabetes mellitus, established at least 6 months prior to enrollment
  • Hemoglobin A1c >8

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.
  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: NCT02011529

Contacts
Contact: Jessica Lowe, BS 206-744-4565 jmlowe1@uw.edu
Contact: Lydia Chwastiak, MD, MPH 206-744-4840 lchwast@uw.edu

Locations
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Jessica Lowe    206-744-4565      
Sub-Investigator: Brent Wisse, MD         
Sub-Investigator: Michael McDonell, PhD         
Sub-Investigator: Wayne Katon, MD         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Lydia Chwastiak, MD, MPH University of Washington
  More Information

Publications:
Responsible Party: Lydia Chwastiak, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02011529     History of Changes
Other Study ID Numbers: 44422-G, R21DK096286-01A1
Study First Received: December 9, 2013
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 30, 2014