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

NCT02029989 | Completed Results

• 1 other identifier: 090M72212
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemia; Diabetes; Hypertension

Keywords

Metabolic Syndrome; Antipsychotics; Schizophrenia; Bipolar Disorder; Diabetes; Dyslipidemia; Hyperlipidemia; Hypertension; Obesity; Medication Therapy Management (MTM); Pharmacist; Comprehensive Medication Management (CMM); Health Disparity; Monitoring; Point of Care Testing; Chronic Persistent Mental Illness

Outcome Measures

Primary Outcomes (1)

• Metabolic Syndrome (MetS)

  compare test results in subjects between the PCS and NCS groups, with or without pre-existing MetS and/or related metabolic conditions at baseline

  Baseline

Study Arms (2)

Extended Treatment Group

EXPERIMENTAL

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

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

Usual Treatment Group

ACTIVE COMPARATOR

Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference

Device: Glucose and lipids; Device: Glycosylated Hemoglobin A1c; Device: Blood Pressure and Heart Rate; Device: Body mass index; Device: Waist and Hip circumference

Interventions

Glucose and lipids DEVICE

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

Also known as: Cholestech LDX ® by Inverness Medical www.cholestech.com

Extended Treatment Group; Usual Treatment Group

Glycosylated Hemoglobin A1c DEVICE

Point-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c

Also known as: A1c Now® by Bayer HealthCare

Extended Treatment Group; Usual Treatment Group

Blood Pressure and Heart Rate DEVICE

Point-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate

Also known as: Omron ® Ultra Premium blood pressure monitor Model HEM-790IT

Extended Treatment Group; Usual Treatment Group

Body mass index DEVICE

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

Also known as: HealthOMeter® 500KL

Extended Treatment Group; Usual Treatment Group

Waist and Hip circumference DEVICE

Measurement for Central Obesity Waist and Hip circumference

Also known as: QM2000 Circumference measuring tape

Extended Treatment Group; Usual Treatment Group

Comprehensive Medication Management BEHAVIORAL

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

Also known as: CMM, Medication Therapy Management, MTM

Extended Treatment Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Currently or previously seen by a CMM pharmacist

Sponsors & Collaborators

• University of Minnesota: lead
• Medica Foundation: collaborator

Study Sites (1)

Human Development Center

Duluth, Minnesota, 55812, United States

Location

Related Publications (2)

• Schneiderhan ME, Shuster SM, Davey CS. Twelve-month prospective randomized study of pharmacists utilizing point-of-care testing for metabolic syndrome and related conditions in subjects prescribed antipsychotics. Prim Care Companion CNS Disord. 2014 Oct 30;16(5):10.4088/PCC.14m01669. doi: 10.4088/PCC.14m01669. eCollection 2014.

  PMID: 25667811 RESULT

• Schneiderhan ME, Li X. Observed Sex Differences in Cardiometabolic Indices in Patients on Antipsychotics: Secondary Analyses of a 12-Month Multicenter, Randomized, Controlled Trial. Prim Care Companion CNS Disord. 2021 Apr 8;23(2):19m02493. doi: 10.4088/PCC.19m02493.

  PMID: 34000112 RESULT

MeSH Terms

Conditions

Hyperlipidemias; Diabetes Mellitus; Hypertension; Metabolic Syndrome; Schizophrenia; Bipolar Disorder; Dyslipidemias; Obesity

Interventions

Blood Pressure; Heart Rate; Body Mass Index; Carubicin; Medication Therapy Management; myotubularin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Body Weights and Measures; Body Constitution; Anthropometry; Investigative Techniques; Physiological Phenomena; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration

Limitations and Caveats

Limitations include: 1) Short time duration to achieve metabolic outcome goals, 2) Smaller than anticipated sample size, 3) High number of subjects lost to follow up after 12-months.

Results Point of Contact

• Title: Dr. Mark E. Schneiderhan
• Organization: UMN, College of Pharmacy

meschnei@d.umn.edu

8452540458

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: January 8, 2014
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 4, 2024
• Results First Posted: May 15, 2014

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)