Cluster randomised controlled trial for late life depression in socioeconomically deprived areas of São Paulo, Brazil

巴西圣保罗社会经济贫困地区晚年抑郁症的整群随机对照试验

• 批准号: MR/L016702/1
• 负责人: Ricardo Araya
• 金额: $ 21.26万
• 依托单位: London School of Hygiene & Tropical Medicine
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2014
• 资助国家: 英国
• 起止时间: 2014 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FL016702%2F1
• 关键词: Cluster; randomised; controlled; trial; late

Depression in late-life is common, costly, and can have devastating consequences on the life of older people, their close relatives and society. Notwithstanding this, it goes frequently unrecognised and untreated. The Brazilian population is ageing rapidly, with already 20 million people aged 60 or more. The Brazilian health care system, especially mental health care, is poorly prepared to meet this challenge. In keeping with WHO recommendations, there is an urgent need to develop feasible and cost-effective depression treatments in primary care for old people with depression living in low- and middle-income countries. The Family Health Strategy, the new Brazilian primary care model, provides an excellent network to test a collaborative, stepped-care, community-based psychosocial intervention for this neglected sub-group of the population. We are proposing a programme that puts emphasis on using more efficiently existing human resources within Family Health Teams, improving 'usual care', and adding simple innovations to the routine work of the primary care staff, such as improved case finding, active outreach, systematic review of cases at team meetings, and empowering non-specialist professionals to act as case managers with due training and support. This programme aims to overcome the main barriers for treating old people with depression in primary care, such as patients' social isolation and difficulties to access services, lack of skills and support of staff to deliver effective mental health interventions, and poor coordination among members of staff in the care of elderly people. This proposal aims to compare the effectiveness and cost-effectiveness of a psychosocial, community-based intervention managed mainly by nurse assistants employed by the existing primary care system against 'enhanced' usual care in reducing depressive illness and improving functioning among adults 60 years or older from poor socioeconomic backgrounds in São Paulo, Brazil. This will be a two-arm cluster randomised controlled trial involving 1,236 participants registered with 20 Family Health Units (clusters). Those in the intervention arm will receive a psychosocial intervention and improved case management led by a nurse assistant based in primary care but with a major role liaising with the community. The intervention will be mostly delivered at home and will last 8 months. Nurse assistants will be supported with tablet computers to deliver the intervention, keep medical notes, communicate with others including supervisors, and to receive further training and ongoing support. Nurse assistants acting as case managers will liaise closely with other members of the primary care team to ensure the best care possible is offered (collaborative care). Those participants who do not improve with the intervention will be discussed in regular team meetings and further clinical decisions adopted, if needed. The control group will receive 'enhanced' usual care alone in so far as cases being identified and assessed periodically and the clinical team receiving an updated training in the management of depression at the start of the trial. We will compare the recovery of cases (PHQ-9 total scores <5) across arms at 4 and 10 months after entering the trial using an intention-to-treat analysis. We will also assess functioning and quality of life. Direct and indirect costs in both arms will be measured to undertake a cost-effectiveness analysis. Dissemination of findings will include scientific reports, workshops, media awareness, and meetings with policy makers. The new Brazilian primary care model has attracted interest from many other LMIC and an intervention such as this has great potential for portability to other LMIC.

晚年的抑郁是普遍的，昂贵的，可能会对老年人，近亲和社会的生活产生毁灭性的后果。尽管如此，它还是经常未被认可和未经处理。巴西人口正在迅速衰老，已经有2000万人年龄在60岁以上。巴西医疗保健系统，尤其是心理保健系统，准备应对这一挑战。为了与谁的建议保持一致，迫切需要为生活在低收入和中等收入国家的抑郁症的老年人中开发可行且具有成本效益的抑郁症治疗。家庭健康策略是新的巴西初级保健模型，为这一被忽视的人群的协作，基于社区的社区心理心理干预提供了一个出色的网络。我们提出了一项计划，该计划强调在家庭健康团队中使用更有效的现有人力资源，改善“通常的护理”，并为初级保健人员的日常工作增加简单的创新，例如改善案件发现，积极的宣传，对案件的系统性审查，对团队会议的案件进行系统性审查，并赋予非特殊专业人员的案件管理和应有培训的案件管理者。该计划旨在克服治疗初级保健抑郁症的老年人的主要障碍，例如患者的社会隔离和难以获得服务，缺乏技能和员工的支持，无法提供有效的心理健康干预措施，以及在老年人照顾老年人方面的员工之间的不良协调。该建议旨在比较现有初级保健系统雇用的护士助理管理的社区心理，基于社区干预的有效性和成本效益，以防止“增强”在降低抑郁症和改善巴西SãoPaulo社会经济背景的60岁或更早的成年人中的“增强”通常的护理。这将是一项两臂群集随机对照试验，涉及1,236名参与者，并注册了20个家庭卫生单位（集群）。干预部门的人将接受心理心理干预，并改善了由基于初级保健的护士助理领导的案件管理，但与社区的重要角色相关。干预措施将主要是在家中进行的，并将持续8位护士助手提供平板电脑的支持，以提供干预，保留医疗笔记，与包括主管在内的其他人进行交流，并获得进一步的培训和持续的支持。担任案例经理的护士助理将与初级保健团队的其他成员紧密联系，以确保提供最佳的护理（协作护理）。那些没有改善干预措施的参与者将在常规的团队会议上讨论，并在需要的情况下采用进一步的临床决策。就案件定期识别和评估，对照组将单独接受“增强”通常的护理，并且在试验开始时接受了最新的抑郁症培训培训。我们将在使用意向性治疗分析进入试验后的4和10个月后4和10个月跨臂的病例（PHQ-9总分<5）的恢复。我们还将评估生活质量和生活质量。将衡量双方的直接和间接成本以进行成本效益分析。调查结果的传播将包括科学报告，研讨会，媒体意识以及与政策制定者的会议。新的巴西初级保健模式引起了许多其他LMIC的兴趣，类似的干预措施具有对其他LMIC的可移植性的巨大潜力。

项目成果

Investigating Software Requirements for Systems Supporting Task-Shifted Interventions: Usability Study.

调查支持任务转移干预的系统的软件要求：可用性研究。

• DOI: 10.2196/11346
• 发表时间: 2019
• 期刊: Journal of medical Internet research
• 影响因子: 7.4
• 作者: Van De Ven P