Trajectories of Post-stroke Multidimensional Health

NCT ID: NCT04704635

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-12
• Study Completion Date: 2023-09-18

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ischemic stroke/TIA

Patients with ischemic stroke or transient ischemic attack

No interventions assigned to this group

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medicine Greifswald

OTHER

Sponsor Role: lead

Responsible Party

Susanne Wurm

Principal Investigator, Head of Prevention Research and Social Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Agnes Flöel, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald

Robert Fleischmann, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald

Bettina von Sarnowski, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald

Locations

University Medicine Greifswald

Greifswald, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 34187831 (View on PubMed)

Other Identifiers

NeuroAdapt

Identifier Type: -

Identifier Source: org_study_id