About this trial
One in five people in Italy has a mental disorder, with depression being the most common and schizophrenia the most severe. People with mental illness have a higher risk of cardio-metabolic and oncologic comorbidities. They also face disparities in accessing appropriate care, with a 20-year life expectancy reduction. IN-TIME will employ an innovative and highly interdisciplinary approach to characterize barriers to healthcare in people with mental illness for informing interventions and enhancing screening, diagnostic pathways and health outcomes. The project will provide: 1) population-based evidence and characterization of disparities in diagnosis and care for cancer and cardio-metabolic disorders; 2) a fine-grained identification of modifiable barriers, such as those relating to stigma and communication; 3) change promoting interventions, including a policy brief to orient clinical guidelines and best practice to reduce stigma, improve doctor-patient communication and optimize care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 40-70 years;
ICD-10 diagnosis of schizophrenia spectrum disorder (F20-F29), depressive disorder (F32-F33), or bipolar disorder (F31);
Ability to provide written informed consent.
Both sexes are eligible.
Disqualifiers
Age <40 years or >70 years.
Inability to provide informed consent.
Absence of an ICD-10 diagnosis of schizophrenia spectrum disorder (F20-F29), depressive disorder (F32-F33), or bipolar disorder (F31).
Trial population
Potential participants will be identified through outpatient clinics at IRCCS Ospedale San Raffaele and ASST Santi Paolo e Carlo. Eligible participants will be approached and invited to participate in the study and will undergo screening based on predefined eligibility criteria. The target population includes adults aged 40-70 years with schizophrenia spectrum disorder, depressive disorder, or bipolar disorder. A total of 120 participants will be recruited, 60 at each study site, with both sexes included.
Trial design
Other
Retrospective
Treatments tested in this trial
Not applicable - observational study
Other interventionNot applicable - observational study
Treatment groups
Trial outcomes
Primary outcomes
Timely access to cancer and cardiometabolic screening and early diagnosis and related healthcare barriers
For the observational cross-sectional part of the study, the investigators will assess barriers to timely access to cancer and cardiometabolic screening, diagnosis and care in adult patients with schizophrenia spectrum disorder, depressive disorder or bipolar disorder. Participants will undergo standardized assessments and an ad-hoc semi-structured interview exploring personal experiences of healthcare access, screening, diagnostic pathways, communication with healthcare professionals, and perceived barriers and facilitators to care. Interviews will be audio-recorded and analysed using qualitative methods and Natural Language Processing (NLP). A total of 120 participants will be enrolled at two sites: IRCCS Ospedale San Raffaele (n=60) and ASST Santi Paolo e Carlo (n=60).
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS San Raffaele
Lead sponsor
ASST Santi Paolo e Carlo
Collaborator
Istituto Universitario di Studi Superiori - IUSS
Collaborator
HPA (Health Protection Agency) of the Metropolitan City of Milan
Collaborator
DG Welfare Regione Lombardia
Collaborator
University College, London
Collaborator
Accademia Lombarda di Sanità Pubblica
Collaborator
This trial is not recruiting at the moment. You can still explore other options: