Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624462
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Effectiveness of a Pragmatic Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of a Pragmatic Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients39 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 kgm2 or BMI 27 kgm2 and concomitant prediabetes diabetes hypertension sleep apnoea andor dyslipidaemia
Patients will be enrolled in an open-label randomized controlled parallel-group trial with an allocation-ratio of 11 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
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 patients39 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 kgm2 or BMI 27 kgm2 and concomitant prediabetes diabetes hypertension sleep apnoea andor dyslipidaemia
Patients will be enrolled in an open-label randomized controlled parallel-group trial with an allocation-ratio of 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None