TEAMcare for Diabetes in Mental Health Centers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02011529|
Recruitment Status : Completed
First Posted : December 13, 2013
Last Update Posted : October 5, 2015
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 or disease||Intervention/treatment||Phase|
|Diabetes||Other: TEAMcare treatment of diabetes||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Team Approach to Improve the Quality of Diabetes Care for Patients With Schizophrenia|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
|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
- Hemoglobin A1c [ Time Frame: 6 months ]
- Blood Pressure [ Time Frame: 6 months ]
- LDL cholesterol [ Time Frame: 6 months ]
- Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02011529
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Lydia Chwastiak, MD, MPH||University of Washington|