Clinical trial NCT04704635: Trajectories of Post-stroke Multidimensional Health
Official title: The Relationship Between Trajectories of Post-stroke Disability and Self-rated Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Ischemic
Transient Ischemic Attack
Adaptation, Psychological
Mental Health Impairment
Adjustment
Self-Rated Health
Aging
Sense of Coherence
Keywords: Old Age
Mental Health
Psychological Health
Self-Rated Health
Quality of Life
Views on Aging
Resilience
Salutogenesis
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 330
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with acute ischemic stroke/transient ischemic attack (TIA) are enrolled during their acute treatment (1-5 days post-acute ischemic stroke/TIA). Patients with an ABCD2 score ≤ 2 are excluded to reduce the chance of inclusion of patients with TIA mimic. The number of TIA patients is limited to 20% of the sample to avoid a bias towards TIA and to represent common incidents of acute ischemic stroke.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Modified Rankin Scale (self-reported)
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of self-rated health
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Secondary outcomes:
measure: Change of Barthel Index (self-reported)
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of Impact of Stroke Scale 16
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of European Health Interview Survey Physical Activity Questionnaire
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of IMET (Index for the Assessment of Participation Restrictions)
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of Fatigue Severity Scale
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of Patient Health Questionnaire-8
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of Pittsburgh Sleep Quality Index (assessment in case of sufficient capacities)
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of Post-Traumatic Stress Syndrome 14 (assessment in case of sufficient capacities)
timeFrame: 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of Questions on Falling
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Other outcomes:
measure: Change of SHARE FI
timeFrame: 1-5 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)
measure: Change of Brief-Illness Perception Questionnaire
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of De Jong Gierveld Loneliness Scale (assessment in case of sufficient capacities)
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of subjective age
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of AgeCog Scales
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of SOK (Selection, Optimization, Compensation)
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of social support (assessment in case of sufficient capacities)
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of Resilience Scale 13 (assessment in case of sufficient capacities)
timeFrame: 1-5 days post-stroke, 12 months post-stroke
measure: Change of Brief Assessment of Sense of Coherence
timeFrame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
measure: Change of Generalized Self-Efficacy Scale
timeFrame: 1-5 days post-stroke, 12 months post-stroke
measure: Change of Posttraumatic Growth Inventory (assessment in case of sufficient capacities)
timeFrame: 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
Study officials:
affiliation: University Medicine Greifswald
name: Agnes Flöel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medicine Greifswald
name: Robert Fleischmann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medicine Greifswald
name: Bettina von Sarnowski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schafer SK, Fleischmann R, von Sarnowski B, Blasing D, Floel A, Wurm S. Relationship between trajectories of post-stroke disability and self-rated health (NeuroAdapt): protocol for a prospective observational study. BMJ Open. 2021 Jun 29;11(6):e049944. doi: 10.1136/bmjopen-2021-049944.