Trajectories of Post-stroke Multidimensional Health

NCT04704635 | Completed

• 1 other identifier: NeuroAdapt
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Old Age; Mental Health; Psychological Health; Self-Rated Health; Quality of Life; Views on Aging; Resilience; Salutogenesis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Change of Barthel Index (self-reported)

  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

  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

  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)

  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)

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

Other Outcomes (11)

• Change of SHARE FI

  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

  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)

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

Study Arms (1)

Ischemic stroke/TIA

Patients with ischemic stroke or transient ischemic attack

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

University Medicine Greifswald

Greifswald, 17489, Germany

Location

Related Publications (1)

• 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.

  PMID: 34187831 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Personal Satisfaction; Behavior

Study Officials

• Agnes Flöel, PhD

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

• Robert Fleischmann, PhD

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

• Bettina von Sarnowski, PhD

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Prevention Research and Social Medicine

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 11, 2021
• Study Start: May 12, 2021
• Primary Completion: August 30, 2022
• Study Completion: September 18, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

DE (1)