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.

老年抑郁症很常见，代价高昂，并可能对老年人、其近亲和社会的生活造成毁灭性后果。尽管如此，它经常被忽视和治疗。巴西人口正在迅速老龄化，60岁及以上的人口已经达到2000万。巴西的卫生保健系统，特别是精神卫生保健，在应对这一挑战方面准备不足。根据世卫组织的建议，迫切需要在初级保健中为生活在低收入和中等收入国家的老年抑郁症患者开发可行且具有成本效益的抑郁症治疗方法。家庭保健战略是巴西新的初级保健模式，它提供了一个很好的网络，可以测试针对这一被忽视的人口亚群体的协作、分步护理和基于社区的社会心理干预。我们正在提议一项方案，重点是更有效地利用家庭保健小组内现有的人力资源，改善“常规护理”，并在初级保健工作人员的日常工作中增加简单的创新，例如改进病例发现、积极外展、在小组会议上系统地审查病例，以及授权非专业专业人员在适当的培训和支持下担任病例管理人员。该方案旨在克服在初级保健中治疗患有抑郁症的老年人的主要障碍，例如患者的社会孤立和难以获得服务，工作人员缺乏提供有效心理健康干预的技能和支持，以及护理老年人的工作人员之间协调不力。本提案旨在比较在巴西圣保罗<s:1>社会经济背景较差的60岁或以上成年人中，主要由现有初级保健系统雇用的护士助理管理的社会心理、社区干预与“强化”常规护理在减少抑郁症和改善功能方面的有效性和成本效益。这将是一项双组随机对照试验，涉及在20个家庭保健单位（组）注册的1,236名参与者。干预组的患者将接受心理社会干预和改进的病例管理，由一名初级保健护士助理领导，但主要作用是与社区联络。干预将主要在家中进行，持续8个月。护士助理将得到平板电脑的支持，以提供干预，保存医疗记录，与包括主管在内的其他人沟通，并接受进一步的培训和持续的支持。作为病例管理人员的护士助理将与初级保健小组的其他成员密切联系，以确保提供尽可能最好的护理（协作护理）。那些干预后没有改善的参与者将在定期小组会议上讨论，如果需要，将采取进一步的临床决定。只要病例被定期识别和评估，对照组将单独接受“强化”的常规护理，临床团队在试验开始时接受抑郁症管理方面的最新培训。我们将使用意向治疗分析比较各组患者在进入试验后4个月和10个月的恢复情况（PHQ-9总分<5）。我们还将评估功能和生活质量。将衡量这两种武器的直接和间接费用，以进行成本效益分析。研究结果的传播将包括科学报告、讲习班、媒体宣传以及与决策者的会议。新的巴西初级保健模式吸引了许多其他低收入和中等收入国家的兴趣，这样的干预措施具有可移植到其他低收入和中等收入国家的巨大潜力。

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