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

NCT ID: NCT02029989

Last Updated: 2024-04-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Hyperlipidemia Diabetes Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Extended Treatment Group

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

Group Type EXPERIMENTAL

Glucose and lipids

Intervention Type DEVICE

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

Glucose and Lipids

Glycosylated Hemoglobin A1c

Intervention Type DEVICE

Point-of-care (POCT) screening for diabetes

Glycosylated Hemoglobin A1c

Blood Pressure and Heart Rate

Intervention Type DEVICE

Point-of-care (POCT) screening for hypertension

Blood Pressure and Heart Rate

Body mass index

Intervention Type DEVICE

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

Waist and Hip circumference

Intervention Type DEVICE

Measurement for Central Obesity

Waist and Hip circumference

Comprehensive Medication Management

Intervention Type BEHAVIORAL

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

Usual Treatment Group

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

Group Type ACTIVE_COMPARATOR

Glucose and lipids

Intervention Type DEVICE

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

Glucose and Lipids

Glycosylated Hemoglobin A1c

Intervention Type DEVICE

Point-of-care (POCT) screening for diabetes

Glycosylated Hemoglobin A1c

Blood Pressure and Heart Rate

Intervention Type DEVICE

Point-of-care (POCT) screening for hypertension

Blood Pressure and Heart Rate

Body mass index

Intervention Type DEVICE

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

Waist and Hip circumference

Intervention Type DEVICE

Measurement for Central Obesity

Waist and Hip circumference

Interventions

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Glucose and lipids

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

Glucose and Lipids

Intervention Type DEVICE

Glycosylated Hemoglobin A1c

Point-of-care (POCT) screening for diabetes

Glycosylated Hemoglobin A1c

Intervention Type DEVICE

Blood Pressure and Heart Rate

Point-of-care (POCT) screening for hypertension

Blood Pressure and Heart Rate

Intervention Type DEVICE

Body mass index

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

Intervention Type DEVICE

Waist and Hip circumference

Measurement for Central Obesity

Waist and Hip circumference

Intervention Type DEVICE

Comprehensive Medication Management

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Cholestech LDX ® by Inverness Medical www.cholestech.com A1c Now® by Bayer HealthCare Omron ® Ultra Premium blood pressure monitor Model HEM-790IT HealthOMeter® 500KL QM2000 Circumference measuring tape CMM, Medication Therapy Management, MTM

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medica Foundation

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Human Development Center

Duluth, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 25667811 (View on PubMed)

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.

Reference Type RESULT
PMID: 34000112 (View on PubMed)

Other Identifiers

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090M72212

Identifier Type: -

Identifier Source: org_study_id

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