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OpenTrials
Completed

NCT Number: NCT02029989

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

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.

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Key information

Conditions

Hyperlipidemia Bipolar Disorder Bipolar and Related Disorders Body Weight Cardiovascular Diseases Diabetes Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemias Hypertension Insulin Resistance Lipid Metabolism Disorders Mental Disorders Metabolic Diseases Metabolic Syndrome Mood Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Vascular Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Development Center

Duluth, Minnesota, 55812, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Currently or previously seen by a CMM pharmacist

Treatment and study plan

Glucose and lipids

Device

Point-of-care (POCT) screening for diabetes and dyslipidemia.

Glucose and Lipids

Other names: Cholestech LDX ® by Inverness Medical www.cholestech.com

Glycosylated Hemoglobin A1c

Device

Point-of-care (POCT) screening for diabetes

Glycosylated Hemoglobin A1c

Other names: A1c Now® by Bayer HealthCare

Blood Pressure and Heart Rate

Device

Point-of-care (POCT) screening for hypertension

Blood Pressure and Heart Rate

Other names: Omron ® Ultra Premium blood pressure monitor Model HEM-790IT

Body mass index

Device

Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared

Other names: HealthOMeter® 500KL

Waist and Hip circumference

Device

Measurement for Central Obesity

Waist and Hip circumference

Other names: QM2000 Circumference measuring tape

Comprehensive Medication Management

Behavioral

Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management

Other names: CMM, Medication Therapy Management, MTM

Primary outcomes

  1. Metabolic Syndrome (MetS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Medica Foundation

Registry information

Official study title

Can Point-of-care Testing (POCT) and Assistance From Comprehensive Medication Management (CMM) Pharmacists Improve Early Detection and Management of Metabolic Syndrome in Patients Treated With Antipsychotic Medications?

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 8, 2014
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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