Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic

Bjorn H. Ebdrup84 enrolled

Overview

This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness

Severe mental illness (SMI), including schizophrenia spectrum disorders and bipolar disorder, is associated with high mortality rates and cardiovascular disease. Obesity and dysmetabolism caused by antipsychotic medication comprise modifiable risk factors, which remain undertreated. The investigators will address the gaps in cardiometabolic care of SMI patients by examining the effectiveness of a pragmatic metabolic care clinic for patients with SMI. Moreover, the investigators will include qualitative investigation of patients' perspectives in relation to acceptability, satisfaction with care, and motivation for health behaviour change. A total of 84 patients between 18-45 years with diagnoses of schizophrenia spectrum disorders or bipolar disorder will be recruited from inpatient and outpatient clinics in the Mental Health Services of the Capital Region of Denmark. Eligible patients are antipsychotics-treated and present with a 5% weight increase / 5 cm waistline increase since initiation of antipsychotic therapy or body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 and concomitant prediabetes, diabetes, hypertension, sleep apnoea and/or dyslipidaemia. Patients will be enrolled in an open-label randomized controlled parallel-group trial with an allocation-ratio of 1:1 to a pragmatic, specialized metabolic clinic with measurement-based care and evidence-based best-practice treatment or standard care. The primary outcome is the proportion of patients in the intervention group achieving a weight loss ≥5% of initial body weight vs the standard care group at 12 months. Secondary and exploratory outcomes include changes in other cardiovascular risk factors, quality of life, personal recovery and cognitive measures. Finally, qualitative interviews will explore patient experience and contextual factors.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Severe Mental Disorder Metabolic Complication Side-Effect;Medication Schizophrenia Spectrum and Other Psychotic Disorders Bipolar Disorder

Interventions

Treatment in the Meta Care ClinicOTHER

* Consultations by medical doctors with specific metabolic training from the metabolic clinic located at Centre for Addiction and Mental Health in Toronto, Canada, and an exercise physiologist. * Evaluation of their psychopharmacotherapy with consultation and detailed recommendations to the patients' treating psychiatrist and/or general practitioner regarding dosage reductions or switching of psychotropics if this is clinically feasible to reduce the metabolic burden. * Lifestyle interventions * Pharmacotherapy with evidence to support use to mitigate antipsychotic-induced weight gain * Treatment of other cardiovascular risk factors such as dyslipidaemia, hypertension, smoking and diabetes in close collaboration with recognized specialists in endocrinology. * Assessment of plans at conferences with participation of the sponsor, the primary investigator as well as recognized specialists in endocrinology and psychiatry. * Qualitative interviews will be conducted post-intervention.

Standard care with general practitioner and/or outpatient clinicsOTHER

Following measurements after 12 months, patients will receive individualized lifestyle recommendations from an exercise physiologist and a MD will offer to send recommendations regarding the following potential post-trial interventions to the patients' general practitioner and/or outpatient clinic prepared in close collaboration with recognized specialists in psychiatry and endocrinology: * Suggestions regarding relevant psychotropic medication adjustments or switches if this is found relevant and clinically feasible to reduce the metabolic burden. * Suggestions regarding potential add-on of weight reducing pharmacotherapy. * Suggestions regarding pharmacological treatment of other cardiovascular risk factors such as dyslipidaemia, hypertension, smoking and type 2 diabetes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with schizophrenia spectrum disorders (International classification of diseases; ICD-10: DF2x) or bipolar disorder (ICD-10: DF30.x or DF31.x) * Medical treatment with antipsychotics * Age 18-45 years * Legally competent * Able to give informed consent and either: \- Body mass index (BMI) ≥30 kg/m2. Or * BMI ≥27 kg/m2 and at least one of the following: * Hypertension defined as treatment with ≥1 antihypertensive drug or out-of-office / 24-hour, non-invasive ambulatory blood pressure ≥140/90 mmHg within the previous 6 months * Dyslipidaemia defined as treatment with ≥1 lipid-lowering drug or elevated low-density lipoprotein (LDL) cholesterol (≥3.0 mmol/l), elevated triglycerides (≥1.7 mmol/l) or low high-density lipoprotein cholesterol (≥1.2 mmol/l in women and ≥1.0 mmol/l in men) within the previous 6 months * Sleep apnoea (ICD-10 DG473). * Prediabetes or diabetes defined as HbA1c ≥42 mmol/mol or impaired fasting glucose as defined by the International Diabetes Federation within the previous 6 months. Or \- a history of rapid weight gain during antipsychotic therapy defined as increases of either ≥5% body weight or ≥5 cm waist circumference since initiation of antipsychotic therapy. Exclusion Criteria: * Clinical or laboratory evidence of comorbid medical disease not compatible with participation as judged by the research team. * Unstable psychiatric disorder as judged by the research team. * Severe current drug or alcohol misuse as judged by the research team. * Acute suicidal risk.

Locations (1)

Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup

Glostrup Municipality, Capital Region, Denmark

RECRUITING

Outcomes

Primary Outcomes

Proportion of patients achieving a weight loss of ≥5% of initial body weight.

Proportion of patients in the intervention group achieving a weight loss of ≥5% of initial body weight vs the standard care group at 12 months.

Time frame: 12 months

Secondary Outcomes

The metabolic composite score

The metabolic composite score consisting of minimally 0 points and maximally five points (one point per composite; elevated waist circumference, elevated triglycerides, blood pressure, fasting plasma glucose, and reduced high-density lipoprotein), according to the definition and cut-off values of metabolic syndrome by the International Diabetes Federation. A higher score means worse outcomes. Effect measurements: differences in percentage achieving reduction of ≥1 points between groups at 12 months.

Time frame: 12 months

Cardiovascular risk factors

Cardiovascular risk factors as defined below.

Time frame: 12 months

Proportion of patients achieving a weight loss of ≥10% of initial body weight.

Proportion of patients in the intervention group achieving a weight loss of ≥10% of initial body weight vs the standard care group at 12 months.

Time frame: 12 months

Proportion of patients achieving a ≥50% reduction of low-density lipoprotein cholesterol

Proportion of patients in the intervention group achieving a ≥50% reduction of initial low-density lipoprotein cholesterol vs the standard care group at 12 months.

Time frame: 12 months

Body weight

Absolute and relative changes in body weight. Effect measurements: differences in mean changes between groups at 12 months.

Central Contacts

Bjorn H. Ebdrup, MD, Consultant,PhD, Professor,

CONTACT

+4538640840 bjoern.ebdrup@regionh.dk

Data from ClinicalTrials.gov

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