Administrative Supplement: Effectiveness of Implementing an Intensive Blood Pressure Reduction Intervention on Cognitive Decline in Low-income and Minority Hypertensive Patients

总结 非裔美国人和低收入人群承担着不成比例的痴呆症负担， 在认知障碍的试验中代表性不足。收缩压干预试验（SPRINT） 显示，强化血压（BP）干预（目标收缩压<120 mmHg）降低了 与标准BP干预（收缩压目标<140 mmHg）相比，认知障碍。下一 重要的一步是确定如何成功的SPRINT强化血压干预， 在现实世界的诊所环境中实施，以防止认知能力下降。母公司试验的目标（IMP. MIND：R33 AG 068481）是为了测试实施强化BP干预方案的多方面策略 改编自SPRINT，目标收缩压<120 mmHg，用于少数民族和低收入人群的认知功能下降 资源有限的初级保健实践中的高血压患者。我们与36个联邦政府合作， 在路易斯安那州和密西西比州的合格的健康中心诊所（DHCs）进行随机分组试验， 测试多方面的实施策略，对认知功能下降进行强化BP干预， 平均42个月的执行结果。迄今为止，尽管大流行病和重大 飓风，我们已经招募并认知评估了预期的1,260名不同参与者中的399名， 正在收集数据和提供干预措施。拟议的行政补助金将实现 两个主要目标，以支持家长试验的目标和具体目标：1）增加12个额外的小学 护理诊所（集群），以加快招募，丰富研究样本与老年参与者谁是 更有可能经历认知变化，并增加统计功效;和2）提供抗高血压 直接向干预参与者免费提供药物，以提高干预的有效性， 增加组间血压降低的净差异，并改善保留。总的来说，这一行政 补充申请符合并支持母研究的原始目的和目标， 通过以下方式改善试验实施：加快招募速度，丰富参与者的样本， 有兴趣的结果的变化，增加统计能力，提高有效性， 干预，并改善保留。IMPACTS-MIND数据和安全监测委员会（DSMB） 最近对试验提出了以下三项建议（随附报告）：1）增加额外的研究中心，2） 招募老年参与者，3）增加治疗组的收缩压间隔。所有这些 建议将通过拟议的补编目标加以落实。

Summary African American and low-income populations bear a disproportionate burden of dementia and have been underrepresented in trials of cognitive impairment. The Systolic Blood Pressure Intervention Trial (SPRINT) showed that an intensive blood pressure (BP) intervention (target systolic BP <120 mmHg) lowered the risk of cognitive impairment compared to a standard BP intervention (systolic BP target <140 mmHg). A next important step is to determine how the successful SPRINT intensive blood pressure intervention can be implemented in real-world clinic settings to prevent cognitive decline. The goal of the parent trial (IMPACTS- MIND: R33AG068481) is to test a multifaceted strategy for implementing an intensive BP intervention protocol adapted from SPRINT targeting systolic BP <120 mmHg on cognitive decline in racial minority and low-income hypertensive patients in resource-constrained primary care practices. We have partnered with 36 federally qualified health center clinics (FQHCs) in Louisiana and Mississippi to conduct a cluster-randomized trial to test a multifaceted implementation strategy for an intensive BP intervention on decline in cognitive function and implementation outcomes over an average of 42 months. To date and despite the pandemic and major hurricanes, we have recruited and cognitively assessed 399 of an expected 1,260 diverse participants, and data collection and intervention delivery are ongoing. The proposed administrative supplement will accomplish two major objectives in support of the parent trial objectives and specific aims: 1) add 12 additional primary care clinics (clusters) in order to speed up recruitment, enrich the study sample with older participants who are more likely to experience cognitive change, and increase statistical power; and 2) provide antihypertensive medications directly to intervention participants at no cost to improve the effectiveness of the intervention, increase the net difference in BP reduction between groups, and improve retention. Overall, this administrative supplement application is in line with and supports the original objective and aims of the parent study and will improve trial conduct by: increasing speed of recruitment, enriching the sample for participants more likely to have changes in the outcome of interest, increasing statistical power, increasing the effectiveness of the intervention, and improving retention. The IMPACTS-MIND Data and Safety Monitoring Board (DSMB) has recently made the following three recommendations for the trial (report attached): 1) adding additional sites, 2) recruiting older participants, and 3) increasing the systolic BP separation by treatment arm. All of these recommendations will be addressed by the proposed supplement objectives.