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Trajectories of Post-stroke Multidimensional Health

The Relationship Between Trajectories of Post-stroke Disability and Self-rated Health

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04704635
Acronym
NeuroAdapt
Enrollment
330
Registered
2021-01-11
Start date
2021-05-12
Completion date
2023-09-18
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Old Age, Mental Health, Psychological Health, Self-Rated Health, Quality of Life, Views on Aging, Resilience, Salutogenesis

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.

Interventions

None listed

Sponsors

University Medicine Greifswald
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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-strokeDegree of disability and dependency
Change of self-rated health1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke1-Item assessment of self-rated health

Secondary

MeasureTime frameDescription
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-strokeMeasure of performance in activities of daily living
Change of Impact of Stroke Scale 161-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-strokeAssessment of the impact of stroke on four domains (i.e., strength, hand function, mobility, and activities of daily living)
Change of European Health Interview Survey Physical Activity Questionnaire1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-strokeAssessment 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-strokeAssessment 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-strokeAssessment of restrictions of participation (according to the WHO concept)
Change of Fatigue Severity Scale1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-strokeAssessment of fatigue
Change of Patient Health Questionnaire-81-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-strokeAssessment of depressive symptoms
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-strokeAssessment of sleep quality (3 items)
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-strokeAssessment of posttraumatic stress symptoms
Change of Questions on Falling1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke5 items on falls and fear of falling

Other

MeasureTime frameDescription
Change of Brief-Illness Perception Questionnaire1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-strokeAssessment of illness perceptions
Change of De Jong Gierveld Loneliness Scale (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-strokeAssessment of feelings of loneliness
Change of subjective age1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-strokeAssessment of subjective age
Change of AgeCog Scales1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-strokeAssessment of self-perception of aging
Change of SOK (Selection, Optimization, Compensation)1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-strokeAssessment of healthy lifestyle
Change of social support (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-strokeAssessment of social support (GEDA/EHIS)
Change of Resilience Scale 13 (assessment in case of sufficient capacities)1-5 days post-stroke, 12 months post-strokeAssessment of trait-resilience
Change of Brief Assessment of Sense of Coherence1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-strokeAssessment of sense of coherence
Change of Generalized Self-Efficacy Scale1-5 days post-stroke, 12 months post-strokeAssessment of self-efficacy (4 items)
Change of Posttraumatic Growth Inventory (assessment in case of sufficient capacities)6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-strokeAssessment of posttraumatic growth (10 items)
Change of SHARE FI1-5 days post-stroke, 6 weeks post-stroke (no GSA), 3 months post-stroke (no GSA), 6 months post-stroke (no GSA), 12 months post-stroke (no GSA)Assessment of Frailty including grip strength assessment (GSA)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026