TEAMcare for Diabetes in Mental Health Centers

Diabetes Clinical Trial

Official title:

A Team Approach to Improve the Quality of Diabetes Care for Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011529
• Other study ID #: 44422-G
• Secondary ID: R21DK096286-01A1
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: October 1, 2015
• Start date: November 2013
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Brief Psychiatric Rating Scale (BPRS)		6 months	No
Primary	Hemoglobin A1c		6 months	No
Secondary	Blood Pressure		6 months	No
Secondary	LDL cholesterol		6 months	No