ImprovINg the TIMEly Diagnosis and Treatment of Cancer and Cardio-metabolic Diseases in People With Mental Disorders: Reducing Health Disparities Through Integrated Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Timely access to cancer and cardiometabolic screening and early diagnosis and related healthcare barriers
研究概览
简要总结
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.
研究设计
- 研究类型
- 观察性
- 观察模型
- 其他
- 时间视角
- 回顾性
入排标准
- 年龄范围
- 40 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 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.
- Participants recruited at IRCCS Ospedale San Raffaele or ASST Santi Paolo e Carlo.
排除标准
- 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).
研究组 & 干预措施
People with severe mental disorders
干预措施: Not applicable - observational study (Other)
结局指标
主要结局
Timely access to cancer and cardiometabolic screening and early diagnosis and related healthcare barriers
时间窗: Baseline
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).
次要结局
未报告次要终点
研究者
标识符
- NCT 编号
- NCT07843433
- 其他研究编号
- CET 262-2026, RF-2024-12378662
日期
- 首次提交
- (9天前)
- 首次发布
- (前天)
- 主要完成日期
- (2年后)
- 研究完成日期
- (3年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
