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通过互联健康增强老龄化的康复(REACH)研究:一项准实验性临床试验的研究方案。

The rehabilitation enhancing aging through connected health (REACH) study: study protocol for a quasi-experimental clinical trial.

机构信息

Spaulding Rehabilitation Hospital, Boston, MA, USA.

Department of PM&R, Harvard Medical School, Boston, MA, USA.

出版信息

BMC Geriatr. 2017 Sep 20;17(1):221. doi: 10.1186/s12877-017-0618-x.

Abstract

BACKGROUND

Mobility limitations among older adults increase the risk for disability and healthcare utilization. Rehabilitative care is identified as the most efficacious treatment for maintaining physical function. However, there is insufficient evidence identifying a healthcare model that targets prevention of mobility decline among older adults. The objective of this study is to evaluate the preliminary effectiveness of a physical therapy program, augmented with mobile tele-health technology, on mobility function and healthcare utilization among older adults.

METHODS

This is a quasi-experimental 12-month clinical trial conducted within a metropolitan-based healthcare system in the northeastern United States. It is in parallel with an existing longitudinal cohort study evaluating mobility decline among community-dwelling older adult primary care patients over one year. Seventy-five older adults (≥ 65-95 years) are being recruited using identical inclusion/exclusion criteria to the cohort study. Three aims will be evaluated: the effect of our program on 1) physical function, 2) healthcare utilization, and 3) healthcare costs. Changes in patient-reported function over 1 year in those receiving the intervention (aim 1) will be compared to propensity score matched controls (N = 150) from the cohort study. For aims 2 and 3, propensity scores, derived from logistic regression model that includes demographic and diagnostic information available through claims and enrollment information, will be used to match treatment and control patients in a ratio of 1:2 or 1:3 from a Medicare Claims Registry derived from the same geographic region. The intervention consists of a one-year physical therapy program that is divided between a combination of outpatient and home visits (6-10 total visits) and is augmented on a computerized tablet using of a commercially available application to deliver a progressive home-based exercise program emphasizing lower-extremity function and a walking program.

DISCUSSION

Incorporating mobile health into current healthcare models of rehabilitative care has the potential to decrease hospital visits and provide a longer duration of care. If the hypotheses are supported and demonstrate improved mobility and reduced healthcare utilization, this innovative care model would be applicable for optimizing the maintenance of functional independence among community-dwelling older adults.

TRIAL REGISTRATION

ClinicalTrial.gov Identifier: NCT02580409 (Date of registration October 14, 2015).

摘要

背景

老年人的活动能力受限会增加残疾和医疗保健利用的风险。康复护理被认为是维持身体功能最有效的治疗方法。然而,目前还没有足够的证据确定针对老年人活动能力下降的医疗保健模式。本研究的目的是评估一种物理治疗方案的初步有效性,该方案辅以移动远程医疗技术,以提高老年人的移动功能和医疗保健利用。

方法

这是一项在美国东北部大都市区医疗保健系统内进行的准实验性 12 个月临床试验。它与一项现有的纵向队列研究并行,该研究评估了社区居住的老年初级保健患者在一年中移动能力下降的情况。正在使用与队列研究相同的纳入/排除标准招募 75 名老年人(≥ 65-95 岁)。将评估三个目标:我们的方案对 1)身体功能、2)医疗保健利用和 3)医疗保健成本的影响。接受干预的患者在 1 年内报告的功能变化(目标 1)将与队列研究中的倾向评分匹配对照组(N=150)进行比较。对于目标 2 和 3,将从同一地理区域的医疗保险索赔登记处派生的倾向评分,用于从索赔和注册信息中获得的人口统计学和诊断信息的逻辑回归模型中得出,以 1:2 或 1:3 的比例匹配治疗和对照患者。该干预措施包括为期一年的物理治疗方案,该方案分为门诊和家庭访问(共 6-10 次访问),并在计算机平板电脑上使用商业可用应用程序进行增强,以提供强调下肢功能和步行计划的渐进式家庭锻炼计划。

讨论

将移动健康纳入康复护理的现有医疗保健模式具有减少住院次数和提供更长时间护理的潜力。如果假设得到支持并证明移动能力提高和医疗保健利用减少,这种创新的护理模式将适用于优化社区居住的老年人的功能独立性维持。

试验注册

ClinicalTrial.gov 标识符:NCT02580409(注册日期 2015 年 10 月 14 日)。

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