Trajectories of Post-stroke Multidimensional Health (NeuroAdapt)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 330

Contacts and Locations

Study Locations

• Germany
  • Greifswald, Germany, 17489
    • University Medicine Greifswald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ischemic stroke/TIA; Patients with ischemic stroke or transient ischemic attack

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of SHARE FI	Assessment of Frailty including grip strength assessment (GSA)	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)
Change of Brief-Illness Perception Questionnaire	Assessment of illness perceptions	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of De Jong Gierveld Loneliness Scale (assessment in case of sufficient capacities)	Assessment of feelings of loneliness	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of subjective age	Assessment of subjective age	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of AgeCog Scales	Assessment of self-perception of aging	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of SOK (Selection, Optimization, Compensation)	Assessment of healthy lifestyle	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of social support (assessment in case of sufficient capacities)	Assessment of social support (GEDA/EHIS)	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of Resilience Scale 13 (assessment in case of sufficient capacities)	Assessment of trait-resilience	1-5 days post-stroke, 12 months post-stroke
Change of Brief Assessment of Sense of Coherence	Assessment of sense of coherence	1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Change of Generalized Self-Efficacy Scale	Assessment of self-efficacy (4 items)	1-5 days post-stroke, 12 months post-stroke
Change of Posttraumatic Growth Inventory (assessment in case of sufficient capacities)	Assessment of posttraumatic growth (10 items)	6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Investigators: Principal Investigator: Agnes Flöel, PhD, University Medicine Greifswald; Principal Investigator: Robert Fleischmann, PhD, University Medicine Greifswald; Principal Investigator: Bettina von Sarnowski, PhD, University Medicine Greifswald

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2021
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): September 18, 2023

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Mental Health; Quality of Life; Resilience; Psychological Health; Salutogenesis; Old Age; Self-Rated Health; Views on Aging
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemic Stroke; Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: NeuroAdapt

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No