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

Primary Purpose

Hyperlipidemia, Diabetes, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glucose and lipids
Glycosylated Hemoglobin A1c
Blood Pressure and Heart Rate
Body mass index
Waist and Hip circumference
Comprehensive Medication Management
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hyperlipidemia focused on measuring 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

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Family Life Mental Health Center
  • Human Development Center
  • Range Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extended Treatment Group

Usual Treatment Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 30, 2013
Last Updated
April 30, 2018
Sponsor
University of Minnesota
Collaborators
Medica Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02029989
Brief Title
Point-of-Care Testing (POCT) Detection and Management of Metabolic Syndrome in Patients With Mental Illness
Official 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?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Medica Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extended Treatment Group
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Treatment Group
Arm Type
Active Comparator
Arm Description
Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference
Intervention Type
Device
Intervention Name(s)
Glucose and lipids
Other Intervention Name(s)
Cholestech LDX ® by Inverness Medical www.cholestech.com
Intervention Description
Point-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids
Intervention Type
Device
Intervention Name(s)
Glycosylated Hemoglobin A1c
Other Intervention Name(s)
A1c Now® by Bayer HealthCare
Intervention Description
Point-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c
Intervention Type
Device
Intervention Name(s)
Blood Pressure and Heart Rate
Other Intervention Name(s)
Omron ® Ultra Premium blood pressure monitor Model HEM-790IT
Intervention Description
Point-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate
Intervention Type
Device
Intervention Name(s)
Body mass index
Other Intervention Name(s)
HealthOMeter® 500KL
Intervention Description
Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
Intervention Type
Device
Intervention Name(s)
Waist and Hip circumference
Other Intervention Name(s)
QM2000 Circumference measuring tape
Intervention Description
Measurement for Central Obesity Waist and Hip circumference
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Medication Management
Other Intervention Name(s)
CMM, Medication Therapy Management, MTM
Intervention Description
Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management
Primary Outcome Measure Information:
Title
Metabolic Syndrome (MetS)
Description
compare test results in subjects between the PCS and NCS groups, with or without pre-existing MetS and/or related metabolic conditions at baseline
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark E Schneiderhan, PharmD
Organizational Affiliation
University of Minnesota, College of Pharmacy, Duluth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family Life Mental Health Center
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Human Development Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Range Mental Health Center
City
Hibbing
State/Province
Minnesota
ZIP/Postal Code
55746
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34000112
Citation
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.
Results Reference
derived
PubMed Identifier
25667811
Citation
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.
Results Reference
derived

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

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