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

Not Applicable

Recruiting

• Conditions: Severe Mental Disorder; Metabolic Complication; Side-Effect;Medication; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar Disorder
• Interventions: Other: Treatment in the Meta Care Clinic; Other: Standard care with general practitioner and/or outpatient clinics

• Registration Number: NCT06624462
• Lead Sponsor: Bjorn H. Ebdrup

Brief Summary

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 80 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, psychopathology, and cognitive measures. Finally, qualitative interviews will explore patient experience and contextual factors.

Study Timeline

• Study Start: 2023-10-10
• Status Verified: 2024-09
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Study First Posted: 2024-10-03
• Last Update Posted: 2024-10-03
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment in the Meta Care Clinic	Treatment in the Meta Care Clinic	The patients who after randomization are allocated to the treatment arm will receive 12 months of treatment in a pragmatic metabolic clinic. Patients will receive measurements/monitoring at least 3 times during the study period: Upon enrolment, after 6 months and after 12 months.
Standard care with general practitioner and/or outpatient clinics	Standard care with general practitioner and/or outpatient clinics	The patients who after randomization are allocated for standard care will continue with their current psychiatric out-patient clinic and/or contact with their general practitioner. Patients will receive measurements/monitoring upon enrolment and after 12 months.

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving a weight loss of ≥5% of initial body weight.	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular risk factors	12 months	Cardiovascular risk factors as defined below.
Proportion of patients achieving a weight loss of ≥10% of initial body weight.	12 months	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.
The metabolic composite score	12 months	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.
Body weight	12 months	Absolute and relative changes in body weight. Effect measurements: differences in mean changes between groups at 12 months.
Waist circumference	12 months	Absolute and relative changes in waist circumference. Effect measurements: differences in mean changes between groups at 12 months.
Body mass index	12 months	Changes in body mass index (BMI) where weight and height will be combined to report BMI in kg/m\^2. Effect measurements: differences in mean changes between groups at 12 months.
Glucose	12 months	Fasting plasma glucose. Effect measurements: differences in mean changes between groups at 12 months.
Insulin	12 months	Fasting Plasma insulin. Effect measurements: differences in mean changes between groups at 12 months.
The homeostatic Model Assessment for Insulin Resistance	12 months	The homeostatic Model Assessment for Insulin Resistance (HOMA-IR) measured using fasting plasma glucose and fasting plasma insulin.; Effect measurements: differences in mean changes between groups at 12 months.
Total cholesterol	12 months	Fasting plasma total cholesterol. Effect measurements: differences in mean changes between groups at 12 months.
Low-density lipoprotein cholesterol	12 months	Fasting plasma Low-density lipoprotein (LDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months.
High-density lipoprotein cholesterol	12 months	Fasting plasma high-density lipoprotein (HDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months.
Very Low-density lipoprotein cholesterol	12 months	Fasting plasma Very Low-density lipoprotein (VLDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months.
Triglycerides	12 months	Fasting plasma triglycerides. Effect measurements: differences in mean changes between groups at 12 months.
Heart rate	12 months	Resting heart rate. Effect measurements: differences in mean changes between groups at 12 months.
Blood pressure	12 months	Clinic blood pressure. Effect measurements: differences in mean changes between groups at 12 months.
Hemoglobin A1c	12 months	Hemoglobin A1c (HbA1c). Effect measurements: differences in mean changes between groups at 12 months.

Trial Locations

Locations (1)

Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup; 🇩🇰 Glostrup, Capital Region, Denmark