在博茨瓦纳农村和蒙特利尔城市与老年人进行认知健康的真实参与式研究（APROACH）：一项试点随机对照试验的方案。

文献信息

中文摘要

引言： 越来越多的老年人患有痴呆症，尤其是在低收入和中等收入国家。大多数预防依赖于控制增加痴呆症风险的状况，如高血压、糖尿病以及视力和听力损失。最近的药物治疗效果有限且价格昂贵得令人望而却步。社会隔离会增加痴呆症的风险，有证据表明，增加社会参与的干预措施可以降低这种风险，可能是通过支持执行功能来实现的。真实参与式研究的三个关键特征——共同治理、使用证据和创新——与执行功能的要素相一致。我们的试点测试在加拿大蒙特利尔和博茨瓦纳农村进行参与式痴呆症预防的可行性和可接受性。
方法与分析： 这项试点随机对照试验将在蒙特利尔城市和博茨瓦纳的两个农村社区招募65岁及以上、社会隔离（没有带薪或志愿工作，未婚）的女性和男性。在博茨瓦纳，我们将把一个社区的参与者随机分配为立即接受干预，而对照社区将在18个月后接受干预。在蒙特利尔，个体参与者将在按共同关注点分组之前或之后被随机分配到立即或延迟干预组。我们的目标是在博茨瓦纳招募至少100名参与者，在蒙特利尔招募100名。干预有六个步骤：个人确定优先关注点；参与者加入有共同关注点的小组；小组讨论关注点和潜在解决方案；小组与其他利益相关者分享关注点和可能的解决方案；实施解决方案；以及对过程进行自我评估。我们将使用额叶评估成套测验来测量执行功能，并应用问卷在基线、18个月和33个月时测量整体大脑健康、身体健康和社会隔离。我们将在干预期结束时分析变化的叙述，以了解参与者对干预的体验。
伦理与传播： 麦吉尔大学医学与健康科学学院机构审查委员会于2024年9月18日批准了整个项目，研究编号：A06-M27-24A。CIUSSS西中蒙特利尔研究伦理委员会（REB）的社会心理研究委员会（REC）于2025年3月3日批准了在蒙特利尔招募临床相关参与者，项目编号2025-4112。博茨瓦纳卫生部健康研究与发展司于2024年6月24日批准了在博茨瓦纳的研究，参考编号：HPRD 6/14/1。在博茨瓦纳，我们将在两个试点社区的社区会议上以及由卫生部和地方政府与传统事务部社会发展司召集的政府和非政府利益相关者中传播研究结果。在蒙特利尔，我们将在研究会议和其他相关论坛上传播研究结果。我们将在相关的本地、国家和国际学术会议和会议上进行口头和海报展示，并在同行评审、索引的学术期刊上发表关于研究结果的论文。
试验注册号： ISRCTN14273485。

英文摘要

INTRODUCTION: Increasing numbers of older adults live with dementia especially in low- and middle-income countries. Most prevention relies on controlling conditions that increase the risk of dementia, such as hypertension, diabetes and sight and hearing loss. Recent pharmacological treatments have limited efficacy and are prohibitively expensive. Social isolation increases the risk of dementia and evidence suggests interventions to increase social engagement can reduce the risk possibly by supporting executive function. Three key features of authentic participatory research - shared governance, use of evidence and innovation - align with elements of executive function. Our pilot tests the feasibility and acceptability of participatory dementia prevention in Montreal, Canada and rural Botswana.
METHODS AND ANALYSIS: This pilot randomised controlled trial will recruit women and men aged 65 years and older who are socially isolated (not in paid or voluntary employment, not married) in urban Montreal and two rural communities in Botswana. In Botswana, we will randomly allocate participants in one community to receive the intervention immediately while the control community will receive the intervention after 18 months. In Montreal, individual participants will be randomly allocated to immediate or delayed intervention groups before or after their grouping by shared concern. We aim to recruit at least 100 participants in Botswana and 100 in Montreal. The intervention has six steps: individuals identify priority concerns; participants join groups with shared concerns; groups discuss the concern and potential solutions; groups share the concern and possible solutions with other stakeholders; implementation of solutions; and self-evaluation of the process. We will measure executive function using the Frontal Assessment Battery, and apply a questionnaire to measure integral brain health, physical health and social isolation at baseline, at 18 months and at 33 months. We will analyse narratives of change at the end of the intervention periods to understand participants' experience of the intervention.
ETHICS AND DISSEMINATION: The McGill University Faculty of Medicine and Health Sciences Institutional Review Board approved the entire project on 18 September 2024, Study number: A06-M27-24A. The Psychosocial Research Committee (REC) of CIUSSS West-Central Montreal Research Ethics Board (REB) approved recruitment of clinic-related participants in Montreal on 3 March 2025, Project 2025-4112. The Health Research and Development Division of the Ministry of Health, Botswana, approved the study in Botswana on 24 June 2024, Reference number: HPRD 6/14/1.In Botswana, we will disseminate the findings in community meetings in the two pilot communities and with government and non-government stakeholders convened by the Ministry of Health and the Social Development Department of the Ministry of Local Government and Traditional Affairs. In Montreal, we will disseminate the findings in research meetings and in other relevant fora. We will give oral and poster presentations about the study in relevant local, national and international academic conferences and meetings and publish papers about the findings in peer-reviewed, indexed academic journals.
TRIAL REGISTRATION NUMBER: ISRCTN14273485.