Clinical trial NCT06781801: Improving Heart and Metabolic Health in People With Severe Mental Illness Through a Long-term Clinical Trial
Official title: Longitudinal Approach to Generate Positive Cardiometabolic Health Outcomes in Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychotic Disorders
Keywords: Psychotic disorders
Cardiometabolic diseases
Quality of life
Cost-effectiveness
Cardiometabolic risk indicators
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: The Swedish Society of Medicine
First posted: 2025-01-17
Enrollment: 644
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal, multicenter, naturalistic, multicomponent, quasi-experimental, superiority, case-control clinical trial.
Primary purpose: PREVENTION

Brief summary: Cardiometabolic diseases are prevalent among individuals with psychotic disorders, significantly contributing to their shorter lifespan, reduced quality of life, and economic impact on individuals and society. To improve cardiometabolic health, effective and individualized interventions are crucial. Psychosis outpatient clinics are ideal for these interventions due to regular patient visits and the availability of diverse health professionals. The investigators have developed and want to test a comprehensive intervention program to improve cardiometabolic health, enhance quality of life, and promote healthy lifestyles specifically for people with psychotic disorders at psychiatric outpatient clinics in Gothenburg.

This clinical trial aims to include 644 individuals with psychotic disorders from six outpatient clinics in the Department of Psychotic Disorders at Sahlgrenska University Hospital in Gothenburg. Two outpatient clinics will provide the LAGOM-intervention, while the other clinics will serve as controls, offering "care as usual". The intervention group will receive multidisciplinary support integrated into the routine clinical procedures. The intervention includes regular follow-ups and use of motivational tools, including body composition analyzer and cardiovascular risk prediction algorithm (QRISK3).

If the intervention effectively improves cardiometabolic health, enhances quality of life for this vulnerable group, and proves cost-effective, it can serve as a model program for implementation in Region Västra Götaland.


Eligibility criteria: Inclusion Criteria:

1. Adults, ≥18 years, meeting ICD-10 diagnostic criteria for any one of the schizophrenia spectrum disorders (F20-F25 or F28-F29).
2. Has the ability to sign informed consent.

Exclusion Criteria:

1. Having an electrical medical implant like pacemaker or other mechanical implants.
2. Pregnant women.
3. Deemed unsuitable for inclusion at the discretion of the investigator.
4. Previous participation in the clinical trial.
5. Under treatment with compulsory care.

Primary outcomes:
measure: Change in body mass index.
timeFrame: At 36 months from baseline.
measure: Change in Waist-hip ratio.
timeFrame: At 36 months from baseline.
measure: Change in systolic blood pressure.
timeFrame: At 36 months from baseline.
measure: Change in diastolic blood pressure.
timeFrame: At 36 months from baseline.
measure: Change in triacylglycerol/high density lipoprotein-cholesterol ratio.
timeFrame: At 36 months from baseline.
measure: Change in total cholesterol/HDL-C ratio.
timeFrame: At 36 months from baseline.
measure: Change in plasma glucose.
timeFrame: At 36 months from baseline.
Secondary outcomes:
measure: Change in cardiovascular disease (CVD) events or risk scores based on the SCORE2 algorithm.
timeFrame: At 36 months from baseline.
Other outcomes:
measure: Change in quality of life.
timeFrame: At 36 months from baseline.
measure: Change in high-sensitivity CRP.
timeFrame: At 36 months from baseline.
measure: Change in HbA1c.
timeFrame: At 36 months from baseline.
measure: Cost description.
timeFrame: At 36 months from baseline.
measure: Quality-Adjusted Life Years.
timeFrame: At baseline and at 12 months from baseline.
measure: Quality-Adjusted Life Years.
timeFrame: At 24 months from baseline.
measure: Quality-Adjusted Life Years.
timeFrame: At 36 months from baseline.
measure: Incremental cost-effectiveness ratio.
timeFrame: At 36 months from baseline.
measure: Change in alcohol habits.
timeFrame: At 36 months from baseline.
measure: Change in tobacco habits.
timeFrame: At 36 months from baseline.
measure: Change in eating habits.
timeFrame: At 36 months from baseline.
measure: Change in physical activity.
timeFrame: At 36 months from baseline.
measure: Requirements for achieving a change in targeted lifestyle.
timeFrame: At 36 months from baseline.
Locations:
city: Gothenburg
country: Sweden
facility: Psykosmottagning Centrum
city: Gothenburg
country: Sweden
facility: Psykosmottagning Nordost
city: Gothenburg
country: Sweden
facility: Psykosmottagning Öster
city: Gothenburg
country: Sweden
facility: Psykosmottagning Hisingen
city: Gothenburg
country: Sweden
facility: Psykosmottagning Väster
city: Mölndal
country: Sweden
facility: Psykosmottagning Mölndal
Study officials:
References: