NCT05407948

Brief Summary

A long-term follow-up study of patients who acquired a stroke or traumatic brain injury (TBI) 5-15 years ago. Primary objective is to describe the interaction between measures of cognitive reserve and neuropsychological variables, psychological variables and healthcare usage in relation to outcome (i.e work return, satisfaction with life, psychological well-being and overall outcome) after stroke or traumatic brain injury. Secondary objectives are to describe differences in fatigue related to cognitive reserve after stroke or TBI and to describe differences in health-care usage related to cognitive reserve after stroke or TBI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

3.4 years

First QC Date

June 1, 2022

Last Update Submit

June 3, 2022

Conditions

Keywords

NeuropsychologyCognitive reserveReturn-to-work

Outcome Measures

Primary Outcomes (2)

  • Return to work

    Degree of return to work according to degree of health insurance benefit received by the Swedish Social Insurance Agency

    5-15 years after injury

  • Life Satisfaction Scale (LiSat-11)

    Life Satisfaction with life overall as well as with specific areas of life. Each area is grade on a scale from 1 to 6 where higher score indicates better satisfaction.

    5-15 years after injury

Secondary Outcomes (4)

  • Glasgow Outcome Scale Extended (GOSE)

    5-15 years after injury

  • Hospital Anxiety and Depression Scale (HADS)

    5-15 years after injury

  • Fatigue

    5-15 years after injury

  • Health care consumption

    3 years before injury to 4 years after injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Former patients at the Brain Injury Rehabilitation Team in Sandviken, Sweden, who had suffered a stroke or a traumatic brain injury between the years 2003-2016 were invited to participate in the study.

You may qualify if:

  • Stroke or TBI between the years 2003-2016
  • Previous or ongoing contact with the outpatient brain injury rehabilitation team in Region Gävleborg
  • Currently living in Region Gävleborg. -

You may not qualify if:

  • Patients with an intellectual disability (IQ\>70) or who have acquired a new brain injury will be excluded -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandvikens närsjukhus

Sandviken, Gävleborg County, 81189, Sweden

Location

Related Publications (36)

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    PMID: 25562311BACKGROUND
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    PMID: 12392240BACKGROUND
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    BACKGROUND
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    PMID: 21044708BACKGROUND
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    PMID: 12691338BACKGROUND
  • E. Ekstrand, J. Lexell, and C. Brogårdh,

    BACKGROUND
  • Hellstrom T, Kaufmann T, Andelic N, Soberg HL, Sigurdardottir S, Helseth E, Andreassen OA, Westlye LT. Predicting Outcome 12 Months after Mild Traumatic Brain Injury in Patients Admitted to a Neurosurgery Service. Front Neurol. 2017 Apr 10;8:125. doi: 10.3389/fneur.2017.00125. eCollection 2017.

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    PMID: 12801182BACKGROUND
  • Carlozzi NE, Kirsch NL, Kisala PA, Tulsky DS. An examination of the Wechsler Adult Intelligence Scales, Fourth Edition (WAIS-IV) in individuals with complicated mild, moderate and Severe traumatic brain injury (TBI). Clin Neuropsychol. 2015;29(1):21-37. doi: 10.1080/13854046.2015.1005677. Epub 2015 Feb 3.

    PMID: 25646823BACKGROUND
  • Stenberg J, Haberg AK, Follestad T, Olsen A, Iverson GL, Terry DP, Karlsen RH, Saksvik SB, Karaliute M, Ek JAN, Skandsen T, Vik A. Cognitive Reserve Moderates Cognitive Outcome After Mild Traumatic Brain Injury. Arch Phys Med Rehabil. 2020 Jan;101(1):72-80. doi: 10.1016/j.apmr.2019.08.477. Epub 2019 Sep 25.

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MeSH Terms

Conditions

Brain Injuries, TraumaticStroke

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 7, 2022

Study Start

November 2, 2018

Primary Completion

March 30, 2022

Study Completion

April 21, 2022

Last Updated

June 7, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

In order to fulfill the requirements of the ethical approvement of the study, results and data will be presented at a group level in publications, rendering identification of individual patients impossible

Locations