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

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?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02029989
Enrollment
121
Registered
2014-01-08
Start date
2010-02-28
Completion date
2012-02-29
Last updated
2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DEVICEGlucose and lipids

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

DEVICEGlycosylated Hemoglobin A1c

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

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

DEVICEBody mass index

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

DEVICEWaist and Hip circumference

Measurement for Central Obesity Waist and Hip circumference

BEHAVIORALComprehensive Medication Management

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

Sponsors

Medica Foundation
CollaboratorOTHER
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Metabolic Syndrome (MetS)Baselinecompare test results in subjects between the PCS and NCS groups, with or without pre-existing MetS and/or related metabolic conditions at baseline

Countries

United States

Participant flow

Recruitment details

Subjects were recruited at three community mental health sites in Minnesota site (Human Development Center - Duluth, MN; Range Mental Health Center - Hibbing, MN; Family Life Mental Health Center - Coon Rapids, MN; with subjects assigned to receive either pharmacist CMM services (PCS) or no pharmacist CMM services (NCS)/Control Group.

Participants by arm

ArmCount
Pharmacist Comprehensive Medication Management Service (PCS)
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 Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids A1c Now®: Point-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared QM2000 Circumference measuring tape: Measurement for Central Obesity Waist and Hip circumference Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management
60
No Comprehensive Medication Management Services (NCS)
Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids A1c Now®: Point-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared QM2000 Circumference measuring tape: Measurement for Central Obesity Waist and Hip circumference
60
Total120

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyChange of location23
Overall StudyDeath01
Overall StudyLost to Follow-up97
Overall StudyPhysician Decision20
Overall StudyProtocol Violation10
Overall StudyWithdrawal by Subject10
Overall StudyWithdrawal: Fear of needles10

Baseline characteristics

CharacteristicTotalNo Comprehensive Medication Management Services (NCS)Pharmacist Comprehensive Medication Management Service (PCS)
Abdominal Obesity101 participants51 participants50 participants
Age, Continuous42.9 years
STANDARD_DEVIATION 11.3
43.5 years
STANDARD_DEVIATION 10.62
42.32 years
STANDARD_DEVIATION 11.95
Diabetes Risk13 participants6 participants7 participants
High Density Lipoprotein (HDL) Risk89 participants45 participants44 participants
Hypertension Risk52 participants25 participants27 participants
Low Density Lipoprotein (LDL) Risk25 participants12 participants13 participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
5 Participants1 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants4 Participants4 Participants
Race (NIH/OMB)
White
104 Participants53 Participants51 Participants
Sex: Female, Male
Female
71 Participants35 Participants36 Participants
Sex: Female, Male
Male
49 Participants25 Participants24 Participants
Subjects with Metabolic Syndrome based on Point of Care analyses88 participants42 participants46 participants
Total Cholesterol Risk47 participants25 participants22 participants
Triglyceride Risk56 participants32 participants24 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 600 / 60
serious
Total, serious adverse events
0 / 600 / 60

Outcome results

Primary

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

Time frame: Baseline

ArmMeasureValue (NUMBER)
Pharmacist Comprehensive Medication Management Service (PCS)Metabolic Syndrome (MetS)85.2 percentage of participants
No Comprehensive Medication Management Services (NCS)Metabolic Syndrome (MetS)71.2 percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026