Trajectories of Post-stroke Multidimensional Health

Aging Clinical Trial

— NeuroAdapt  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04704635
• Other study ID #: NeuroAdapt
• Status: Completed
• Start date: May 12, 2021
• Est. completion date: September 18, 2023

Study information

• Verified date: November 2023
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: September 18, 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	University Medicine Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Change of Resilience Scale 13 (assessment in case of sufficient capacities)	Assessment of trait-resilience	1-5 days post-stroke, 12 months post-stroke
Other	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
Other	Change of Generalized Self-Efficacy Scale	Assessment of self-efficacy (4 items)	1-5 days post-stroke, 12 months post-stroke
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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