Trajectories of Post-stroke Multidimensional Health

Completed

• Conditions: Stroke, Ischemic; Adjustment; Adaptation, Psychological; Self-Rated Health; Aging; Mental Health Impairment; Sense of Coherence; Transient Ischemic Attack

• Registration Number: NCT04704635
• Lead Sponsor: University Medicine Greifswald

Brief Summary

Stroke is thought to cause disability immediately after stroke followed by a 3-to-6-month recovery period, after which disability levels are supposed to stabilize unless recurrent events occur. However, studies showed that post-stroke recovery is heterogeneous. While some stroke survivors quickly recover, others may show an accelerated accumulation of disability over time. The current prospective observational study will investigate trajectories of multidimensional functioning and self-rated health in the year after stroke. Particularly, the study aims to explore the relationship between trajectories of disability and self-rated health. Moreover, the study will focus on potential predictors of changes in disability and self-rated health, i.e., views on aging and psychological resilience. Patients will be recruited during their stay at the stroke unit and participate in a face-to-face interview and four follow-up telephone interviews in the post-stroke year.

Detailed Description

Ischemic strokes have shown to have long-term impact on functional health apart from their acute effects on neurological functioning. Stroke survivors may experience long-term physical disability, psychopathological symptoms and cognitive decline. Even though these potential consequences are well studied, knowledge on post-stroke trajectories of multidimensional functional health according to the Word Health Organization's (WHO) International Classification of Functioning, Disability and Health (ICF) and their predictors is rare. Particularly, there is a lack of studies investigating the trajectories of self-rated health and different indicators of functional health in the year post-stroke. Therefore, the current study aims to explore trajectories of disability and self-rated health in the year post-stroke, and is the first to analyze the relationship between these trajectories. Thereby, the study addresses the research question whether changes in disability can be predicted by prior self-rated health or changes of self-rated health, and vice versa. Moreover, the study examines the correspondence between changes of disability and self-rated health in the year post-stroke. Additionally, views on aging and psychological resilience, which are relevant to coping processes, are studied as predictors of changes in disability and self-rated health. Patients recruited during their stay at the stroke unit will participate in one face-to-face interview in hospital and four telephone follow-up interviews at 6 weeks, 3 months, 6 months and 12 months post-stroke. Moreover, physical functioning will be externally assessed during their hospital stay. To increase the knowledge on post-stroke trajectories of multidimensional health is of major importance to identify patients at risk for accelerated accumulation of disability. Findings from the current study may contribute to the improvement of post-stroke rehabilitation and secondary prevention.

Study Timeline

• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-11
• Study Start: 2021-05-12
• Primary Completion: 2022-08-30
• Study Completion: 2023-09-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Age ≥ 50 years
• Acute ischemic stroke/high-risk transient ischemic attack (TIA; ABCD2 score ≥ 3)
• Language: Fluent in German
• Written informed consent of patient or caregiver

Exclusion Criteria

• Low-risk TIA (ABCD2 score ≤ 2)
• Severe cognitive impairment (i.e., incomplete orientation)
• Severe communication disorder
• Index event > 5 days prior to enrolment
• Life expectancy < 1 year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of self-rated health	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke	1-Item assessment of self-rated health
Change of Modified Rankin Scale (self-reported)	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke	Degree of disability and dependency

Secondary Outcome Measures

Name	Time	Method
Change of Fatigue Severity Scale	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke	Assessment of fatigue
Change of Post-Traumatic Stress Syndrome 14 (assessment in case of sufficient capacities)	6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke	Assessment of posttraumatic stress symptoms
Change of Questions on Falling	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke	5 items on falls and fear of falling
Change of Impact of Stroke Scale 16	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke	Assessment of the impact of stroke on four domains (i.e., strength, hand function, mobility, and activities of daily living)
Change of Patient Health Questionnaire-8	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke	Assessment of depressive symptoms
Change of Barthel Index (self-reported)	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke	Measure of performance in activities of daily living
Change of European Health Interview Survey Physical Activity Questionnaire	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke	Assessment of physical activity
Change of European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke	Assessment of quality of life
Change of IMET (Index for the Assessment of Participation Restrictions)	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke	Assessment of restrictions of participation (according to the WHO concept)
Change of Pittsburgh Sleep Quality Index (assessment in case of sufficient capacities)	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke	Assessment of sleep quality (3 items)

Trial Locations

Locations (1)

University Medicine Greifswald; 🇩🇪 Greifswald, Germany