TEAMcare for Diabetes in Mental Health Centers

NCT02011529 | Completed

• 2 other identifiers: 44422-GR21DK096286-01A1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  6 months

Secondary Outcomes (2)

• Blood Pressure

  6 months

• LDL cholesterol

  6 months

Other Outcomes (1)

• Brief Psychiatric Rating Scale (BPRS)

  6 months

Study Arms (2)

TEAMcare treatment of diabetes

ACTIVE COMPARATOR

Other: TEAMcare treatment of diabetes

Treatment as usual

NO INTERVENTION

Participants randomized to treatment as usual will receive their usual mental health treatment and primary care treatment

Interventions

TEAMcare treatment of diabetes OTHER

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.

TEAMcare treatment of diabetes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (2)

• 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.

  PMID: 21190455 BACKGROUND

• Chwastiak LA, Luongo M, Russo J, Johnson L, Lowe JM, Hoffman G, McDonell MG, Wisse B. Use of a Mental Health Center Collaborative Care Team to Improve Diabetes Care and Outcomes for Patients With Psychosis. Psychiatr Serv. 2018 Mar 1;69(3):349-352. doi: 10.1176/appi.ps.201700153. Epub 2017 Dec 1.

  PMID: 29191136 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lydia Chwastiak, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 13, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 5, 2015

Record last verified: 2015-10

Locations

US (1)