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Completed

NCT Number: NCT04704635

Trajectories of Post-stroke Multidimensional 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.

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Key information

Conditions

Stroke, Ischemic Adaptation, Psychological Adjustment Aging Behavior Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Ischemic Stroke Mental Health Impairment Nervous System Diseases Personal Satisfaction Psychological Well-Being Self-Rated Health Sense of Coherence Stroke Transient Ischemic Attack Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medicine Greifswald

Greifswald, 17489, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change of Modified Rankin Scale (self-reported)

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Degree of disability and dependency

  2. Change of self-rated health

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    1-Item assessment of self-rated health

Secondary outcomes

  1. Change of Barthel Index (self-reported)

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Measure of performance in activities of daily living

  2. Change of Impact of Stroke Scale 16

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of the impact of stroke on four domains (i.e., strength, hand function, mobility, and activities of daily living)

  3. Change of European Health Interview Survey Physical Activity Questionnaire

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of physical activity

  4. Change of European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of quality of life

  5. Change of IMET (Index for the Assessment of Participation Restrictions)

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of restrictions of participation (according to the WHO concept)

  6. Change of Fatigue Severity Scale

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of fatigue

  7. Change of Patient Health Questionnaire-8

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of depressive symptoms

  8. Change of Pittsburgh Sleep Quality Index (assessment in case of sufficient capacities)

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of sleep quality (3 items)

  9. Change of Post-Traumatic Stress Syndrome 14 (assessment in case of sufficient capacities)

    Time frame: 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of posttraumatic stress symptoms

  10. Change of Questions on Falling

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    5 items on falls and fear of falling

Other outcomes

  1. Change of SHARE FI

    Time frame: 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)

    Assessment of Frailty including grip strength assessment (GSA)

  2. Change of Brief-Illness Perception Questionnaire

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of illness perceptions

  3. Change of De Jong Gierveld Loneliness Scale (assessment in case of sufficient capacities)

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of feelings of loneliness

  4. Change of subjective age

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of subjective age

  5. Change of AgeCog Scales

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of self-perception of aging

  6. Change of SOK (Selection, Optimization, Compensation)

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of healthy lifestyle

  7. Change of social support (assessment in case of sufficient capacities)

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of social support (GEDA/EHIS)

  8. Change of Resilience Scale 13 (assessment in case of sufficient capacities)

    Time frame: 1-5 days post-stroke, 12 months post-stroke

    Assessment of trait-resilience

  9. Change of Brief Assessment of Sense of Coherence

    Time frame: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of sense of coherence

  10. Change of Generalized Self-Efficacy Scale

    Time frame: 1-5 days post-stroke, 12 months post-stroke

    Assessment of self-efficacy (4 items)

  11. Change of Posttraumatic Growth Inventory (assessment in case of sufficient capacities)

    Time frame: 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke

    Assessment of posttraumatic growth (10 items)

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

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

Acronym: NeuroAdapt

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 11, 2021
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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