Longitudinal Approach to Generate Positive Cardiometabolic Health Outcomes in Severe Mental Illness

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults, ≥18 years, meeting ICD-10 diagnostic criteria for any one of the schizophrenia spectrum disorders (F20-F25 or F28-F29).

• Has the ability to sign informed consent.

Locations
Other Locations
Sweden
Psykosmottagning Centrum
RECRUITING
Gothenburg
Psykosmottagning Hisingen
RECRUITING
Gothenburg
Psykosmottagning Nordost
NOT_YET_RECRUITING
Gothenburg
Psykosmottagning Öster
NOT_YET_RECRUITING
Gothenburg
Psykosmottagning Väster
RECRUITING
Gothenburg
Psykosmottagning Mölndal
RECRUITING
Mölndal
Contact Information
Primary
Hemen Najar, M.D., Ph.D.
hemen.najar@vgregion.se
0046 73 763 13 53
Time Frame
Start Date: 2025-02-27
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 644
Treatments
No_intervention: The control Group (Care as usual)
The care as usual model in Gothenburg includes annual health checks for individuals with psychotic disorders. Patients attend two 45-minute visits for assessments such as blood tests, blood pressure, and weight checks, with results evaluated using standard benchmarks or risk algorithms like SCORE2. Physicians may suggest referrals to primary care or recommend lifestyle changes, including diet, exercise, or substance use adjustments. Identified issues may prompt simple advice or referrals to health promoters for support with smoking cessation, dietary guidance, or group activities.~The 36 ± 6-month clinical trial standardizes data collection at four outpatient clinics without altering care. Eligible patients sign consent, with rescreening allowed if criteria change. The trial uses worksheets for intervention and control groups, with the former including more detailed exams. Self-assessments and standard procedures remain unchanged, and non-participants continue with regular care.
Experimental: The multicomponent intervention group
The annual health checks for the intervention group follow the same structure of two visits as in routine care as usual, with the primary difference being the content of the visits.
Related Therapeutic Areas
Sponsors
Leads: Vastra Gotaland Region
Collaborators: The Swedish Society of Medicine

This content was sourced from clinicaltrials.gov