Point-of-Care Testing (POCT) Detection and Management of Metabolic Syndrome in Patients With Mental Illness

Not Applicable

Completed

• Conditions: Diabetes; Hyperlipidemia; Hypertension
• Interventions: Device: Glucose and lipids; Device: Glycosylated Hemoglobin A1c; Device: Blood Pressure and Heart Rate; Device: Body mass index; Device: Waist and Hip circumference; Behavioral: Comprehensive Medication Management

• Registration Number: NCT02029989
• Lead Sponsor: University of Minnesota

Brief Summary

The study was a 12-month, multi-centered, quasi-experimental design to assess point-of-care (POCT) screening/monitoring of subjects on antipsychotic agents for metabolic syndrome. Subjects were also randomized to either an Extended Treatment Group (ETG) defined by receiving comprehensive medication management (CMM) pharmacist interventions or a Usual Treatment Group (UTG) receiving no CMM interventions. All subjects were recruited from three community mental health clinic settings in Minnesota.

Detailed Description

It is well recognized that patients on antipsychotic agents with mental illness continue to be affected by a severe health disparity due to lack of adequate metabolic monitoring.1-7 A major healthcare concern is the life-expectancy decrease of \~25 years for patients with illnesses such as schizophrenia as compared with the general population. Equally concerning is that patients with severe persistent mental illness (SPMI) continue to have inadequate integration of care between psychiatry and medicine. Because of the difficulty getting patients to primary care or hospital based laboratories, the use of capillary blood, point-of-care tests (POCT) to monitor glucose and lipids in addition to vital signs and other anthropometric measurements in community mental health centers might prove beneficial. It is highly likely that this advanced level of screening in the mental health setting may lead to identifying new metabolic abnormalities or improved treatment with careful monitoring of previously diagnosed metabolic syndrome, diabetes, and/or hypertension in antipsychotic treated patients. It is hypothesized that if metabolic abnormalities are identified; then providing pharmacist CMM consultative services would reduce medication related problems by improving medication adherence, coordination of care between psychiatry and primary care, and outcomes in metabolic indices.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-08
• Results First Submitted: 2014-04-15
• Results First Submitted QC: 2014-04-15
• Results First Posted: 2014-05-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• English speaking
• Age 18-64
• Competent to understand and make medical choices independently

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Exclusion Criteria

• Currently or previously seen by a CMM pharmacist

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Treatment Group	Blood Pressure and Heart Rate	Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference
Usual Treatment Group	Glucose and lipids	Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference
Extended Treatment Group	Glycosylated Hemoglobin A1c	Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management
Extended Treatment Group	Blood Pressure and Heart Rate	Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management
Usual Treatment Group	Body mass index	Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference
Extended Treatment Group	Glucose and lipids	Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management
Usual Treatment Group	Waist and Hip circumference	Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference
Extended Treatment Group	Body mass index	Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management
Extended Treatment Group	Waist and Hip circumference	Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management
Extended Treatment Group	Comprehensive Medication Management	Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management
Usual Treatment Group	Glycosylated Hemoglobin A1c	Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference

Primary Outcome Measures

Name	Time	Method
Metabolic Syndrome (MetS)	Baseline	compare test results in subjects between the PCS and NCS groups, with or without pre-existing MetS and/or related metabolic conditions at baseline

Trial Locations

Locations (1)

Human Development Center; 🇺🇸 Duluth, Minnesota, United States