HyperlipidemiaNCT02029989
Point-of-Care Testing (POCT) Detection and Management of Metabolic Syndrome in Patients With Mental Illness
A study testing Glucose and lipids, Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate in people with Hyperlipidemia and Diabetes, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia, Diabetes, Hypertension
- What is being tested?
- Glucose and lipids, Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- English speaking
- Age 18-64
- Competent to understand and make medical choices independently
Who cannot join
- Currently or previously seen by a CMM pharmacist
Trial locations and contacts
1 site in 1 country.
About this study
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?
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.
Read the 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
- Hyperlipidemia, Diabetes, Hypertension
- Being tested
- Glucose and lipids, Glycosylated Hemoglobin A1c, Blood Pressure and Heart Rate, Body mass index, Waist and Hip circumference
- 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
- Medical subject headings
- Hyperlipidemias, Diabetes Mellitus, Hypertension, Metabolic Syndrome, Schizophrenia, Bipolar Disorder, Dyslipidemias, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose and lipidsDevice
Also called Cholestech LDX ® by Inverness Medical www.cholestech.com
Point-of-care (POCT) screening for diabetes and dyslipidemia.
Glucose and Lipids
Glycosylated Hemoglobin A1cDevice
Also called A1c Now® by Bayer HealthCare
Point-of-care (POCT) screening for diabetes
Glycosylated Hemoglobin A1c
Blood Pressure and Heart RateDevice
Also called Omron ® Ultra Premium blood pressure monitor Model HEM-790IT
Point-of-care (POCT) screening for hypertension
Blood Pressure and Heart Rate
Body mass indexDevice
Also called HealthOMeter® 500KL
Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
Waist and Hip circumferenceDevice
Also called QM2000 Circumference measuring tape
Measurement for Central Obesity
Waist and Hip circumference
Comprehensive Medication ManagementBehavioural
Also called CMM, Medication Therapy Management, MTM
Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Glucose and lipids; Device: Glycosylated Hemoglobin A1c; Device: Blood Pressure and Heart Rate; Device: Body mass index; Device: Waist and Hip circumference |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Medica Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029989
- Sponsor's protocol ID
- 090M72212
- Status last verified
- Apr 2024
- First submitted
- 30 Sep 2013
- Last updated
- 4 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25667811Schneiderhan 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.
PubMed 34000112
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT02029989
- Acronym / sponsor ID
- 090M72212
- Conditions
- Hyperlipidemia, Diabetes, Hypertension
- Keywords
- Metabolic Syndrome, Antipsychotics, Schizophrenia, Bipolar Disorder, Diabetes, Dyslipidemia, Hyperlipidemia, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Medica Foundation
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Posted 15 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Treatment Group | Experimental | 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 ManagementGlucose 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 |
| Usual Treatment Group | Active comparator | Device: Glucose and lipids, Device: Glycosylated Hemoglobin A1c, Device: Blood Pressure and Heart Rate, Device: Body mass index, Device: Waist and Hip circumferenceGlucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- English speaking
- Age 18-64
- Competent to understand and make medical choices independently
Key exclusion criteria (1 listed)
- Currently or previously seen by a CMM pharmacist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose and lipidsAlso: Cholestech LDX ® by Inverness Medical www.cholestech.comPoint-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids | Device | Extended Treatment Group, Usual Treatment Group |
| Glycosylated Hemoglobin A1cAlso: A1c Now® by Bayer HealthCarePoint-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c | Device | Extended Treatment Group, Usual Treatment Group |
| Blood Pressure and Heart RateAlso: Omron ® Ultra Premium blood pressure monitor Model HEM-790ITPoint-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate | Device | Extended Treatment Group, Usual Treatment Group |
| Body mass indexAlso: HealthOMeter® 500KLHeight and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared | Device | Extended Treatment Group, Usual Treatment Group |
| Waist and Hip circumferenceAlso: QM2000 Circumference measuring tapeMeasurement for Central Obesity Waist and Hip circumference | Device | Extended Treatment Group, Usual Treatment Group |
| Comprehensive Medication ManagementAlso: CMM, Medication Therapy Management, MTMDefined at http://www.pcpcc.org/guide/patient-health-through-medication-management | Behavioural | Extended Treatment Group |
Primary outcome
Metabolic Syndrome (MetS)
Time frame: Baseline
compare test results in subjects between the PCS and NCS groups, with or without pre-existing MetS and/or related metabolic conditions at baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25667811Schneiderhan 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 publication: PubMed 34000112Schneiderhan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose and lipids, Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate in people with Hyperlipidemia and Diabetes, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Syndrome (MetS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02029989, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.