背景:糖尿病和高血压是毁灭性的,致命的,以及在老年人中非常常见的昂贵条件。在患有糖尿病的老年人中控制高血压显著减少高血压相关并发症。然而,必须小心降低血压(BP),因为老年人也容易受到低BP和随之而来的伤害。实现“最佳BP控制”(即,避免治疗不足和过度治疗)是此类患者的最终治疗目标。为了实现这一目标,需要定期进行BP监测。家里的血压监测很便宜,方便,广泛使用,和准则认可。然而,主要障碍阻碍了正确使用。这些可以通过使用BP远程监测-BP读数的安全远程传输到健康门户来克服。其中BP数据汇总为提供者和患者使用,有或没有协议化的案件管理。
目的:为了检查增量有效性,安全,成本效益,可用性,以及家庭BP远程监控的可接受性,使用或不使用协议化的案例管理,与社区居住的患有糖尿病和高血压的老年人的“强化常规护理”相比。
方法:300名患者,三臂,将在大埃德蒙顿地区独立居住的患有糖尿病和高血压的老年人中进行具有盲化结局确定的务实随机对照试验。同意的患者将被随机分配到常规护理中,家庭BP远程监控,或家庭BP远程监护加上规范的药剂师病例管理。通常的护理对象将获得家庭BP监测器,但他们和他们的提供者都无法访问远程传输的数据。在两个远程监测的武器中,提供商将接收远程监控的BP数据摘要。在案件管理部门,药剂师病例管理人员将负责审查远程传输的数据,并在BP管理中启动指南一致和规范的变更.
结果:结果将在6个月和12个月时确定。将计算研究臂内变化分数,并在研究臂之间进行比较。这些包括:(1)临床结果:平均24小时动态收缩压在最佳范围内的受试者比例(65-79岁的患者为110-129mmHg,≥80岁的患者为110-139mmHg:主要结果);额外的门诊和家庭BP结果;A1c和血脂;药物,认知,医疗保健使用,心血管事件,和死亡率。(2)安全性结果:低血压的严重发作次数,晕厥,falls,和电解质紊乱(需要第三方援助或医疗护理)。(3)人文成果:生活质量,满意,和药物依从性。(4)经济成果:增量成本,增量成本-效用,与常规护理相比,远程监护±病例管理的BP每mmHg变化的成本(健康付款人和社会观点)。(5)干预对患者和提供者的可用性和可接受性。
结论:远程监护的潜在益处在老年人中仍未得到研究和证实。该试验将全面评估家庭BP远程监测对一系列结果的影响。结果将为在加拿大的支持性居住住宅中实施基于家庭的远程监控提供参考。
背景:Clinicaltrials.govNCT02721667;https://clinicaltrials.gov/ct2/show/NCT02721667(由Webcite在http://www上存档。webcitation.org/6i8tB20Mc)。
BACKGROUND: Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in
seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because
seniors are also susceptible to low BP and attendant harms. Achieving \"optimal BP control\" (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring-the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized
case management.
OBJECTIVE: To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with \"enhanced usual care\" in community-dwelling seniors with diabetes and hypertension.
METHODS: A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors\' residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist
case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the
case management arm, pharmacist
case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management.
RESULTS: Outcomes will be ascertained at 6 and 12 months. Within-study-arm change scores will be calculated and compared between study arms. These include: (1) clinical outcomes: proportion of subjects with a mean 24-hour ambulatory systolic BP in the optimal range (110-129 mmHg in patients 65-79 years and 110-139 mmHg in those ≥80 years: primary outcome); additional ambulatory and home BP outcomes; A1c and lipid profile; medications, cognition, health care use, cardiovascular events, and mortality. (2) Safety outcomes: number of serious episodes of hypotension, syncope, falls, and electrolyte disturbances (requiring third party assistance or medical attention). (3) Humanistic outcomes: quality of life, satisfaction, and medication adherence. (4) Economic outcomes: incremental costs, incremental cost-utility, and cost per mmHg change in BP of telemonitoring ± case management compared with usual care (health payor and societal perspectives). (5) Intervention usability and acceptability to patients and providers.
CONCLUSIONS: The potential benefits of telemonitoring remain largely unstudied and unproven in seniors. This trial will comprehensively assess the impact of home BP telemonitoring across a range of outcomes. Results will inform the value of implementing home-based telemonitoring within supportive living residences in Canada.
BACKGROUND: Clinicaltrials.gov NCT02721667; https://clinicaltrials.gov/ct2/show/NCT02721667 (Archived by Webcite at http://www.webcitation.org/6i8tB20Mc).