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临床试验/NCT03456128
NCT03456128已完成不适用

Reducing Disability Following Hospital Discharge in Vulnerable Older Adults: The CAPABLE Intervention

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2018年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
268
试验地点
2
主要终点
Mean ADL Difficulty Score

研究概览

简要总结

This study evaluates whether the utilization of integrated health services such as help with medications, muscle strengthening, balance training, pain management and home modification interventions can help improve older adults' ability to sleep, balance, walk, and take care of themselves after hospitalization.

详细描述

Currently, there is no evidence-based approach to improve post-hospitalization functional decline. CAPABLE uses a novel inter-professional team involving an occupational therapist, nurse, and handyman to improve ADLs in older adults post-hospitalization.

In a Center for Medicare & Medicaid Innovation (CMMI) demonstration project, CAPABLE demonstrated a 45% reduction of ADL difficulties in older adults from baseline to five months.The significance of this improvement could make the difference between aging at home independently and relocating to institutional care. While these results are encouraging, CAPABLE needs evaluation in real world health delivery contexts with more ethnic diversity.The purpose of this study is to test the effectiveness of CAPABLE in older adults in an active community health care program.

Interventions: CAPABLE Intervention: Participants in the treatment group will receive up to 10 in-home sessions (≤6 visits with an occupational therapist and ≤4 visits from a nurse)-and up to $1500 in safety and modification services from a licensed handyman. Each treatment participant will receive each intervention component (education, assessment, and identification of functional goals, specific strategies tailored to goals and based on protocols). Usual Care Group: Participants in the usual care group will not receive visit from study clinicians and will continue to receive their usual VNSNY CHOICE benefits and healthcare. After baseline, all study participants will be reassessed at 20 weeks and possibly a third interview at 52 weeks. Assessments will be completed by a research assistant masked to treatment condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

1: 1. The outcome assessor will be unaware of which groups the older adults are assigned to.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged ≥ 65 years old;
  • Are 60 days post-hospitalization in an acute care setting and have had a Visiting Nurse Service of New York (VNSNY) visit;
  • Have difficulty with at least one activity of daily living (ADL);
  • Are a member of the VNSNY CHOICE Medicare Advantage Health Plan;
  • Are able to stand with or without assistance; and
  • Are available during the intervention period

排除标准

  • Have significant cognitive impairment identified by the Callahan screening tool;
  • Do not speak English or Spanish;
  • Have had more than 3 hospitalizations within the past 12 months;
  • Are actively receiving radiation or chemotherapy;
  • Have plans to relocate in less than one year;
  • Have diagnoses of the following: Dementia, Alzheimer's, Other Cerebral Degeneration, and serious cognitive impairment or OASIS assessment level 3 response on M1034 "serious progressive conditions that could lead to death within a year"

结局指标

主要结局

Mean ADL Difficulty Score

时间窗: 20-week follow-up period

Change in ADL- the range is 0 - 16, with higher scores indicating that the participant needs a lot of help with performing many ADLs (is more disabled) and lower scores indicating that the participant is not disabled

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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