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临床试验/NCT06553755
NCT06553755进行中(未招募)不适用

Unraveling the Multidimensional Functional Recovery Patterns and Prognostic Factors in Post-Discharged Stroke Survivors: A Retrospective Study

Taipei Medical University1 个研究点 分布在 1 个国家目标入组 1,270 人开始时间: 2024年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,270
试验地点
1
主要终点
Activity Measure for Post-Acute Care (AM-PAC)

研究概览

简要总结

This study aims to compare the 1-year recovery trajectories of multidimensional functional recovery among stroke survivors after discharge from hospital care.

To address this purpose, a retrospective analysis will be conducted using clinical data from two independent cohorts derived from previously published prospective observational studies. The study will conduct generalized estimating equations and mixed-effects regression models to assess differences in recovery trends among stroke subgroups.

The findings will provide detailed profiles of longitudinal changes in functional outcomes one year after discharge from hospital care. These results will clarify how stroke subtypes influence long-term functional outcomes and will guide the development of targeted interventions.

详细描述

Different stroke types have unique pathophysiological mechanisms that likely affect various recovery outcomes. Understanding stroke-subtype-specific functional recovery and outcomes is crucial for effective rehabilitation and discharge planning. However, current evidence does not fully reveal how functional outcomes differ by stroke subtype, leaving gaps in our understanding of how these differences impact post-stroke recovery. Identifying the specific recovery patterns and prognostic factors associated with each stroke subtype can enhance personalized rehabilitation strategies and improve patient care.

To address this purpose, a retrospective study utilizing clinical data from two independent cohorts recruited from collaborative hospitals in Northern Taiwan between 2016 and 2018 will be implemented. The study will employ several outcome measures, including the Participation Measure-3 Domains, 4 Dimensions (PM-3D4D), the Activity Measure for Post-Acute Care (AM-PAC), the modified Rankin Scale (mRS) and other standardized assessment tools. Participants will be assessed from hospital discharge until 12-month follow-up. Data analysis will use generalized estimating equations and mixed-effects regression models to evaluate differences in recovery trends among stroke subgroups.

The findings will offer comprehensive insights into the progression of various functional outcomes of specific stroke subtypes over the course of one year following discharge. The study will also identify factors associated with long-term functional outcomes and investigate how those factors impact the trend of functional recovery. These results will demonstrate the association of stroke subtypes and long-term functional outcomes, facilitating the development of targeted interventions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Stroke survivors
  • aged 20 years or older;
  • were diagnosed with a stroke confirmed by physicians;
  • were assessed at least one of the outcomes of interest, including participation (Participation Measure-3 Domains, 4 Dimensions, PM-3D4D), activity limitations (Activity Measure for Post-Acute Care short forms, AM-PAC), HRQoL (EuroQol-5D-3L, EQ-5D-3L), and cognitive impairments (Montreal Cognitive Assessment, MoCA).

排除标准

  • Stroke survivors who missed all follow-up assessments.

结局指标

主要结局

Activity Measure for Post-Acute Care (AM-PAC)

时间窗: From discharged from acute care up to 1 year

The Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms consists of three subscales that assesses three activity domains: basic mobility (18 items), daily activity (15 items), and applied cognitive (19 items). Each item asks the respondent to rate the difficulty to perform specified activities using a 4-point scale. The summary scores range 18-72, 15-60, 19-76 points respectively among three subscales. Higher score indicates better function of the specific domain. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.

Euro-QoL-5-Dimension-3 Level (EQ-5D-3L)

时间窗: From discharged from acute care up to 1 year

The Euro-QoL-5-Dimension-3 Level (EQ-5D-3L) is used to assess participant's health related quality of life which consist of 5 ordinal scale items and 1 item with visual analog scale. Ordinal scales are rated 0-3 points with higher score indicating the pooer health-related quality of life. visual analog scale are rated by respondents reporting perceived health status with a grade ranging from 0 to 100 with higher score indicating the better health status).

Montreal Cognitive Assessment (MoCA)

时间窗: From discharged from acute care up to 1 year

Montreal Cognitive Assessment (MoCA) is a clinician-reported measure consisting of cognition domains such as: visuospatial skills, executive functions, attention, concentration, calculation, language, abstraction, memory, and orientation. The summary score ranges from 0-30 points with higher scores indicating better cognitive function.

Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)

时间窗: From discharged from acute care up to 1 year

The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community. Respondents are asked to rate each item on four dimensions: (1) 'Diversity of participation' (yes \[1\] vs. no \[0\]); (2) 'Frequency'(5- and 7-point scales, from "never" to "everyday or almost everyday"); (3) 'Desire for change' (yes \[1\] vs. no\[0\]); and (4) 'Perceived difficulty' (4-point scale, from "very difficult" \[1\] to "not difficult at all" \[4\]). Each dimensional score of the PM-3D4D can be separately summed for each domain. Psychometric properties of the PM-3D4D were established in rehabilitation populations.

次要结局

  • Barthel Index (BI)(From discharged from acute care up to 1 year)
  • Modified Rankin Scale (mRS)(From discharged from acute care up to 1 year)
  • The Center for Epidemiologic Studies Depression Scale (CES-D)(From discharged from acute care up to 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Feng-Hang Chang

Professor

Taipei Medical University

研究点 (1)

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