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TEAMcare for Diabetes in Mental Health Centers

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University of Washington

Status

Completed

Conditions

Diabetes

Treatments

Other: TEAMcare treatment of diabetes

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02011529
R21DK096286-01A1 (U.S. NIH Grant/Contract)
44422-G

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

35 participants in 2 patient groups

TEAMcare treatment of diabetes
Active Comparator group
Treatment:
Other: TEAMcare treatment of diabetes
Treatment as usual
No Intervention group
Description:
Participants randomized to treatment as usual will receive their usual mental health treatment and primary care treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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