Aging Clinical Trial
— NeuroAdaptOfficial title:
The Relationship Between Trajectories of Post-stroke Disability and Self-rated Health
NCT number | NCT04704635 |
Other study ID # | NeuroAdapt |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 12, 2021 |
Est. completion date | September 18, 2023 |
Verified date | November 2023 |
Source | University Medicine Greifswald |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Medicine Greifswald | Greifswald |
Lead Sponsor | Collaborator |
---|---|
University Medicine Greifswald |
Germany,
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 |
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