Clinical trial NCT06624462: Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
Official title: Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Mental Disorder
Metabolic Complication
Side-Effect;Medication
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar Disorder
Keywords: Severe mental illness
Overweight and obesity
Antipsychotic medication
Dysmetabolism
Schizophrenia Spectrum Disorders
Bipolar disorder
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Mental Health Centre Glostrup
name: University of Toronto
name: Herlev and Gentofte Hospital
First posted: 2024-10-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, open label, non-blinded randomized controlled trial
Primary purpose: TREATMENT

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\&#39; 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.

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.

Primary outcomes:
measure: Proportion of patients achieving a weight loss of ≥5% of initial body weight.
timeFrame: 12 months
Secondary outcomes:
measure: The metabolic composite score
timeFrame: 12 months
measure: Cardiovascular risk factors
timeFrame: 12 months
measure: Proportion of patients achieving a weight loss of ≥10% of initial body weight.
timeFrame: 12 months
measure: Body weight
timeFrame: 12 months
measure: Waist circumference
timeFrame: 12 months
measure: Body mass index
timeFrame: 12 months
measure: Glucose
timeFrame: 12 months
measure: Insulin
timeFrame: 12 months
measure: The homeostatic Model Assessment for Insulin Resistance
timeFrame: 12 months
measure: Total cholesterol
timeFrame: 12 months
measure: Low-density lipoprotein cholesterol
timeFrame: 12 months
measure: High-density lipoprotein cholesterol
timeFrame: 12 months
measure: Very Low-density lipoprotein cholesterol
timeFrame: 12 months
measure: Triglycerides
timeFrame: 12 months
measure: Heart rate
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
measure: Hemoglobin A1c
timeFrame: 12 months
Other outcomes:
measure: Cardiorespiratory fitness
timeFrame: 12 months
measure: Body composition: Total body fat percentage
timeFrame: 12 months
measure: Body composition: Visceral adipose tissue
timeFrame: 12 months
measure: Body composition: Skeletal muscle mass.
timeFrame: 12 months
measure: Personal recovery - The Brief INSPIRE Measure of Staff Support for Personal Recovery.
timeFrame: 12 months
measure: Personal recovery - The Questionnaire about the Process of Recovery.
timeFrame: 12 months
measure: Psychopathology: The Brief Psychiatric Rating Scale
timeFrame: 12 months
measure: Psychopathology: The Clinical Global Impression Scale
timeFrame: 12 months
measure: Psychopathology: The Calgary Depression Score in Schizophrenia
timeFrame: 12 months
measure: Psychopathology: The Hamilton Depression Rating Scale
timeFrame: 12 months
measure: Psychopathology: The Young Mania Rating Scale
timeFrame: 12 months
measure: Measures of functioning
timeFrame: 12 months
measure: Quality of life - the World Health Organization-5 Well-being index.
timeFrame: 12 months
measure: Cognition - The Symbol Digit Modalities Test (SDMT).
timeFrame: 12 months
measure: Cognition - The Brief Cognitive Assessment Tool in Schizophrenia
timeFrame: 12 months
measure: Smoking Cessation
timeFrame: 12 months
measure: Physical activity
timeFrame: 12 months
measure: Appetite
timeFrame: 12 months
measure: Qualitative evaluation
timeFrame: Time from study start to dropout or 12 months
Locations:
city: Glostrup
country: Denmark
facility: Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup
state: Capital Region
Study officials:
affiliation: Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup | University of Copenhagen
name: Bjorn H. Ebdrup, MD, Consultant,PhD, Professor,
role: STUDY_CHAIR
References: