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| ID | Type | Description | Link |
|---|---|---|---|
| H-23045618 | Other Identifier | Scientific Ethics Committees for the Capital Region of Denmark | |
| p-2023-14342 | Other Identifier | The Danish Data Protection Agency | |
| 2096-00099B | Other Grant/Funding Number | Independent Research Fund Denmark |
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| Name | Class |
|---|---|
| Glostrup University Hospital, Copenhagen | OTHER |
| University of Toronto | OTHER |
| Herlev and Gentofte Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment in the Meta Care Clinic | Active Comparator | 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. |
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| Standard care with general practitioner and/or outpatient clinics | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment in the Meta Care Clinic | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory fitness | Cardiorespiratory fitness assessed by the submaximal Ekblom-Bak test on a mechanically braked cycle ergometer. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Body composition: Total body fat percentage |
Inclusion Criteria:
and either:
- Body mass index (BMI) ≥30 kg/m2.
Or
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bjorn H. Ebdrup, MD, Consultant,PhD, Professor, | Contact | +4538640840 | bjoern.ebdrup@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Bjorn H. Ebdrup, MD, Consultant,PhD, Professor, | Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup | University of Copenhagen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Neuropsychiatric Schizophrenia Research, CNSR, Mental Health Centre Glostrup | Recruiting | Glostrup Municipality | Capital Region | 2600 | Denmark |
Aggregated deidentified data is expected to be available after publication upon request.
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Pragmatic, open label, non-blinded randomized controlled trial
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| Standard care with general practitioner and/or outpatient clinics | Other | 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:
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| 12 months |
| Cardiovascular risk factors | Cardiovascular risk factors as defined below. | 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. | 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. | 12 months |
| Body weight | Absolute and relative changes in body weight. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Waist circumference | Absolute and relative changes in waist circumference. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Body mass index | 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. | 12 months |
| Glucose | Fasting plasma glucose. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Insulin | Fasting Plasma insulin. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| The homeostatic Model Assessment for Insulin Resistance | 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. | 12 months |
| Total cholesterol | Fasting plasma total cholesterol. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Low-density lipoprotein cholesterol | Fasting plasma Low-density lipoprotein (LDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| High-density lipoprotein cholesterol | Fasting plasma high-density lipoprotein (HDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Very Low-density lipoprotein cholesterol | Fasting plasma Very Low-density lipoprotein (VLDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Triglycerides | Fasting plasma triglycerides. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Heart rate | Resting heart rate. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Blood pressure | Clinic blood pressure. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Hemoglobin A1c | Hemoglobin A1c (HbA1c). Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
Total body fat percentage measured with a bioelectrical impedance analysis. Effect measurements: differences in mean changes between groups at 12 months. |
| 12 months |
| Body composition: Visceral adipose tissue | Visceral adipose tissue measured with a bioelectrical impedance analysis. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Body composition: Skeletal muscle mass. | Skeletal muscle mass measured with a bioelectrical impedance analysis. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Personal recovery - The Brief INSPIRE Measure of Staff Support for Personal Recovery. | The Brief INSPIRE Measure of Staff Support for Personal Recovery. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Personal recovery - The Questionnaire about the Process of Recovery. | The Questionnaire about the Process of Recovery (QPR). Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Quality of life - the World Health Organization-5 Well-being index. | The World Health Organization (WHO)-5 Well-being index. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Cognition - The Symbol Digit Modalities Test (SDMT). | The Symbol Digit Modalities Test (SDMT). Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Cognition - The Brief Cognitive Assessment Tool in Schizophrenia | The Brief Cognitive Assessment Tool in Schizophrenia (B-CATS) comprised of the following:
Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Smoking Cessation | Smoking cessation amongst persons who are smoking at baseline measured as self-reported cessation for the past 7 days after 12 months. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Physical activity | Physical activity of weekly self-perceived volumes of different intensities and average daily sedentary hours measured with the International Physical Activity Questionnaire. Effect measurements: differences in mean changes between groups at 12 months | 12 months |
| Appetite | Appetite measured with a digital visual analogue scale (VAS) before the first meal at date of baseline measurements and date of measurements after 12 months as minimum 1 and maximally 10 with higher outcomes depicting more appetite. Effect measurements: differences in mean changes between groups at 12 months. | 12 months |
| Qualitative evaluation | Semi-structured interviews will be conducted following the intervention with patients, who dropped out or completed the intervention, respectively. Patients who complete the intervention will be sampled purposefully to ensure maximum variation in terms of gender, age, and diagnosis, whereas the investigators will interview every patient dropping out (i.e., convenience sampling). Interviews will focus on satisfaction with the delivered care, and sustained motivation for health behaviour change. Data will be analysed by means of inductive-deductive thematic analysis informed by the COM-B model identifying capability, opportunity, and motivation as key factors which need to change in order for a behaviour change intervention to be effective. Adequate sample size for the qualitative evaluation will be guided by information power (also denoted saturation). | Time from study start to dropout or 12 months |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001714 | Bipolar Disorder |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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