Clinical trial NCT06553755: Multidimensional Recovery Patterns and Prognostic Factors After Stroke
Official title: Unraveling the Multidimensional Functional Recovery Patterns and Prognostic Factors in Post-Discharged Stroke Survivors: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke
Keywords: functional status
prognosis
recovery
social participation
stroke subtypes
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 1270
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The retrospective study is based on the clinical data of two independent cohorts from previously published prospective, observational studies. The ethics committee approved these studies at the Taipei Medical University. Both cohorts recruited stroke patients at three hospitals (Taipei Medical University Hospital, Wan Fang Hospital, Shuang Ho Hospital) between January 2016 and September 2018, collecting functional outcomes and person-environment variables since discharged from hospital to 12-month post-discharge follow-up.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Stroke survivors

1. aged 20 years or older;
2. were diagnosed with a stroke confirmed by physicians;
3. 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).

Exclusion Criteria: Stroke survivors who missed all follow-up assessments.

Primary outcomes:
measure: Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: From discharged from acute care up to 1 year
measure: Activity Measure for Post-Acute Care (AM-PAC)
timeFrame: From discharged from acute care up to 1 year
measure: Euro-QoL-5-Dimension-3 Level (EQ-5D-3L)
timeFrame: From discharged from acute care up to 1 year
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: From discharged from acute care up to 1 year
Secondary outcomes:
measure: Barthel Index (BI)
timeFrame: From discharged from acute care up to 1 year
measure: Modified Rankin Scale (mRS)
timeFrame: From discharged from acute care up to 1 year
measure: The Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: From discharged from acute care up to 1 year
Other outcomes:
measure: National Institutes of Health Stroke scale (NIHSS)
timeFrame: From discharged from acute care up to 1 year
measure: Personal factors
timeFrame: From discharged from acute care up to 1 year
measure: Environmental factors
timeFrame: From discharged from acute care up to 1 year
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
References: