Clinical Trials Directory

Trials / Completed

CompletedNCT02029989

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
Phase
N/A
Study type
Interventional
Enrollment
121 (actual)
Sponsor
University of Minnesota · Academic / Other
Sex
All
Age
18 Years – 64 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEGlucose and lipidsPoint-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids
DEVICEGlycosylated Hemoglobin A1cPoint-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c
DEVICEBlood Pressure and Heart RatePoint-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate
DEVICEBody mass indexHeight and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
DEVICEWaist and Hip circumferenceMeasurement for Central Obesity Waist and Hip circumference
BEHAVIORALComprehensive Medication ManagementDefined at http://www.pcpcc.org/guide/patient-health-through-medication-management

Timeline

Start date
2010-02-01
Primary completion
2012-02-01
Completion
2012-02-01
First posted
2014-01-08
Last updated
2024-04-04
Results posted
2014-05-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02029989. Inclusion in this directory is not an endorsement.