Counseling older Americans to control hypertension (COACH)

摘要 尽管已被证实的有效性和令人信服的证据表明，改变治疗生活方式的有益效果 (TLC)在学术研究环境下进行的大型临床试验中降低BP的有效性 以社区为基础的设置仍然不清楚。这在老年患者中尤其如此，他们往往有 血压控制率极低，特别是少数族裔老年人，他们分担了更大的高血压负担 与白人相比，(HTN)相关的结果包括心力衰竭、中风和终末期肾脏疾病。这 RCT提供了一个独特的机会来解决文献中的这一差距。我们将评估一名高年级学生的效果 以中心为基础的综合治疗生活方式干预(MINT-TLC)与对照条件(CC)，对BP的影响 还原。我们假设，随机接受薄层薄层细胞移植的少数族裔老年人在12个月内将表现出更大的血压 减少；增加水果和蔬菜的摄入量；更多的体力活动；更高的百分比变化 体重；减少24小时尿钠排泄；以及血压充足的老年人比例更高 控制力。200名拉丁裔和非裔美国老年人(年龄60岁)，HTN控制不善 (BP&GT；140/90 mm Hg)将从纽约市附属的社区老年中心登记 老年部。处于CC状态的高年级学生将收到一次关于TLC和 NHLBI出版物的印刷版《您的降血压指南》和《关于DASH的事实》 饮食计划“。MINTTLC组的高年级学生将参加为期10周的每周小组课程(强化阶段)； 然后每月举行为期三个月的个人动机访谈(MINT)会议(延长阶段)； 然后每两个月进行一次个人强化薄荷疗程，为期六个月(维护阶段)。薄荷是 旨在帮助参与者做出适当的TLC并培养长期保持这些变化的技能。 薄荷-薄层色谱将由训练有素的研究人员提供。主要结果是患者内部血压的变化。 从基线到12个月，次要结果是有针对性的治疗性生活方式行为水平；以及 12个月时血压控制良好的老年人比例(BP&lt；140/90 mm Hg)。所有结果都将是 使用经过充分验证的程序和措施，在基线和12个月时进行面对面评估。英国石油公司将 使用自动数字血压监测仪进行评估。治疗性生活方式行为将用NCI的 简单的水果/蔬菜和脂肪饮食评估问卷；以及7天体力活动召回。从长远来看 目标是提炼薄荷TLC并将其整合到常规的老年中心高血压监测计划中 作为所获得数据的结果；从而最大限度地将其转化为标准做法。

Abstract Despite the proven efficacy and compelling evidence of the beneficial effects of therapeutic lifestyle changes (TLC) on BP reduction in large clinical trials conducted in academic research settings, its effectiveness in community-based settings remains unclear. This is particularly true among elderly patients who tend to have an abysmally low rate of BP control, especially minority elders, who share a greater burden of hypertension (HTN)-related outcomes including heart failure, stroke, and end-stage kidney disease compared to whites. This RCT offers a unique opportunity to address this gap in the literature. We will evaluate the effect of a senior center-based comprehensive therapeutic lifestyle intervention (MINT-TLC) vs. a Control Condition (CC), on BP reduction. We hypothesize that minority elders randomized to MINT-TLC will exhibit at 12 months a greater BP reduction; increased intake of fruits and vegetables; higher levels of physical activity; higher percent change in weight; reduced 24-hour urinary sodium excretion; and a higher proportion of seniors with adequate BP control. Two hundred Latino and African-American seniors (age > 60 years) with poorly controlled HTN (BP>140/90 mm Hg) will be enrolled from community-based senior centers affiliated with the New York City Department for The Aging. Seniors in the CC condition will receive a single brief advice session on TLC and print versions of NHLBI publications "Your Guide to Lowering Blood Pressure"; and "Facts about the DASH Eating Plan". Seniors in the MINTTLC group will attend weekly group classes for 10 weeks (intensive phase); followed by monthly individual motivational interviewing (MINT) sessions for three months (extended phase); and then bi-monthly individual booster MINT sessions for six months (maintenance phase). MINT-TLC is designed to help participants make appropriate TLC and develop skills to maintain these changes long-term. MINT-TLC will be delivered by trained research personnel. The primary outcome is within-patient change in BP from baseline to 12 months The secondary outcomes are levels of targeted therapeutic lifestyle behaviors; and proportion of seniors with adequate BP control at 12 months (BP<140/90 mm Hg). All outcomes will be assessed in-person at baseline and 12 months by using well-validated procedures and measures. BP will be assessed with an automated digital BP monitor. Therapeutic lifestyle behaviors will be assessed with NCI's brief fruit/vegetable and fat dietary assessment questionnaires; and the 7-day physical activity recall. The longterm goal is to refine MINT-TLC and integrate it into routine senior center hypertension monitoring programs as a result of the data obtained; thus maximizing the likelihood of its translation into standard practice.