Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Proportion of patients achieving a weight loss of ≥5% of initial body weight.
Study Overview
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 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/m
- •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.
- •- 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.
Arms & Interventions
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.
Intervention: Treatment in the Meta Care Clinic (Other)
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.
Intervention: Standard care with general practitioner and/or outpatient clinics (Other)
Outcomes
Primary Outcomes
Proportion of patients achieving a weight loss of ≥5% of initial body weight.
Time Frame: 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 Outcomes
- Low-density lipoprotein cholesterol(12 months)
- Total cholesterol(12 months)
- The metabolic composite score(12 months)
- Cardiovascular risk factors(12 months)
- Proportion of patients achieving a weight loss of ≥10% of initial body weight.(12 months)
- Proportion of patients achieving a ≥50% reduction of low-density lipoprotein cholesterol(12 months)
- Body weight(12 months)
- Waist circumference(12 months)
- Body mass index(12 months)
- Glucose(12 months)
- Insulin(12 months)
- The homeostatic Model Assessment for Insulin Resistance(12 months)
- High-density lipoprotein cholesterol(12 months)
- Very Low-density lipoprotein cholesterol(12 months)
- Triglycerides(12 months)
- Heart rate(12 months)
- Blood pressure(12 months)
- Hemoglobin A1c(12 months)
Investigators
Bjorn H. Ebdrup
MD, consultant, PhD and clinical professor in psychiatry Bjørn Hylsebeck Ebdrup
University of Copenhagen