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

Overview

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

Detailed description

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.

Interventions

• Other Treatment in the Meta Care Clinic
  * 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 *
• Other Standard care with general practitioner and/or outpatient clinics
  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

Primary outcome measures

• Proportion of patients achieving a weight loss of ≥5% of initial body weight. [Time frame: 12 months]

Secondary outcome measures (12)

• The metabolic composite score [Time frame: 12 months]
• Cardiovascular risk factors [Time frame: 12 months]
• Proportion of patients achieving a weight loss of ≥10% of initial body weight. [Time frame: 12 months]
• Proportion of patients achieving a ≥50% reduction of low-density lipoprotein cholesterol [Time frame: 12 months]
• Body weight [Time frame: 12 months]
• Waist circumference [Time frame: 12 months]
• Body mass index [Time frame: 12 months]
• Glucose [Time frame: 12 months]
• Insulin [Time frame: 12 months]
• The homeostatic Model Assessment for Insulin Resistance [Time frame: 12 months]
• Total cholesterol [Time frame: 12 months]
• Low-density lipoprotein cholesterol [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Denmark · 1 center

• Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup — Glostrup Municipality

Identifiers

NCT: NCT06624462 · The Meta Care Clinic · H-23045618 · p-2023-14342 · 2096-00099B

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗