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TEAMcare for Diabetes in Mental Health Centers

Primary Purpose

Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TEAMcare treatment of diabetes
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

TEAMcare treatment of diabetes

Treatment as usual

Arm Description

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

Outcomes

Primary Outcome Measures

Hemoglobin A1c

Secondary Outcome Measures

Blood Pressure
LDL cholesterol

Full Information

First Posted
December 9, 2013
Last Updated
October 1, 2015
Sponsor
University of Washington
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02011529
Brief Title
TEAMcare for Diabetes in Mental Health Centers
Official Title
A Team Approach to Improve the Quality of Diabetes Care for Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEAMcare treatment of diabetes
Arm Type
Active Comparator
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Participants randomized to treatment as usual will receive their usual mental health treatment and primary care treatment
Intervention Type
Other
Intervention Name(s)
TEAMcare treatment of diabetes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Blood Pressure
Time Frame
6 months
Title
LDL cholesterol
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Brief Psychiatric Rating Scale (BPRS)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia Chwastiak, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21190455
Citation
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.
Results Reference
background
PubMed Identifier
29191136
Citation
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.
Results Reference
derived

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TEAMcare for Diabetes in Mental Health Centers

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