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Search / Trial NCT06781801

Improving Heart and Metabolic Health in People With Severe Mental Illness Through a Long-term Clinical Trial

Launched by VASTRA GOTALAND REGION · Jan 13, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Psychotic Disorders Cardiometabolic Diseases Quality Of Life Cost Effectiveness Cardiometabolic Risk Indicators

ClinConnect Summary

This clinical trial is studying how to improve heart and metabolic health in people with severe mental illnesses, particularly those with psychotic disorders like schizophrenia. People with these conditions often face higher risks of heart disease and related health issues, which can affect their overall quality of life. The trial involves 644 adults from six outpatient clinics in Gothenburg, where some will receive a special program called the LAGOM-intervention. This program includes regular health check-ups and support from a team of health professionals to encourage healthy habits and monitor their heart health.

To participate, individuals need to be at least 18 years old and meet specific mental health criteria. Exclusions include anyone with certain medical implants, pregnant women, or those who have been previously involved in this trial. Participants in the intervention group can expect ongoing support and tools to help them track their health, which may lead to a better quality of life. If successful, this program could set a standard for how to help others with similar challenges in the future.

Gender

ALL

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.

About Vastra Gotaland Region

Vastra Gotaland Region is a prominent healthcare organization in Sweden, dedicated to advancing medical research and improving patient care through innovative clinical trials. As a sponsor, the region leverages its extensive network of hospitals and healthcare professionals to facilitate high-quality research initiatives that address pressing health challenges. With a commitment to ethical standards and patient safety, Vastra Gotaland Region strives to foster collaboration between researchers, clinicians, and patients, ensuring that clinical trials contribute valuable insights and advancements in medical science.

Locations

Gothenburg, , Sweden

Gothenburg, , Sweden

Gothenburg, , Sweden

Gothenburg, , Sweden

Gothenburg, , Sweden

Mölndal, , Sweden

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported