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Changes in Physical, Cognitive and Emotional Function 5 and 10 Years After Aneurysmal Subarachnoid Hemorrhage (aSAH)

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ClinicalTrials.gov Identifier: NCT02795533
Recruitment Status : Enrolling by invitation
First Posted : June 10, 2016
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Tonje Haug Nordenmark, Oslo University Hospital

Brief Summary:
The current study is a continuation of the study "Effect of early rehabilitation in patients with acute aSAH" which was approved by the Regional Committee for Medical Research Ethics, South-East Norway, archive number 2011/2189, Clinical Trials number 0925-0586 (Clinical Trials gov. identifier NCT01656317). The original study was a prospective, controlled, interventional study comprising patients managed at the neuro-intermediate ward following repair of a ruptured intracranial aneurysm in 2011-2012. 157 patients signed the informed consent form and were included in the study. Patients were assessed in the acute phase, as well as a 3 and 12 months post ictus. The main research goal of the present study will be to assess physical, cognitive and emotional function 5 and 10 years after aSAH in the 2011-2012 population. In addition we will also describe quality of life and work-status along with the time-course of recovery from the acute sage after aSAH to the chronic phase.

Condition or disease Intervention/treatment
Subarachnoid Hemorrhage Behavioral: Clinical follow-up

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Study Type : Observational
Estimated Enrollment : 157 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Changes in Physical, Cognitive and Emotional Function 5 and 10 Years After Aneurysmal Subarachnoid Hemorrhage (aSAH)
Study Start Date : June 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Clinical follow-up
As part of the regular follow-up of aSAH patients at Oslo University Hospital patients with as aSAH in 2011-2012 will be invited to a clinical interview, medical examination and neuropsychological test. Patients will also be asked to answer Quality of Life Questionnaires.
Behavioral: Clinical follow-up

All included patients will have a clinical follow-up consisting of:

  1. A medical examination
  2. Quality of life questionnaires
  3. Neuropsychological test

All instruments have been translated into Norwegian and validated and tested in clinical practice.





Primary Outcome Measures :
  1. The Rivermead Post Concussion Symptom Questionnaire (RPQ) [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]

Secondary Outcome Measures :
  1. Patient Health Questionnaire (PHQ-9) [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]
  2. Hopkins Symptom Checklist (HSCL-5) [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]
  3. Short Form Health Survey (SF-36) [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]
  4. Fatigue Severity Scale (FSS) [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]
  5. Impact of Event scale (IES) [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]
  6. Community Integration Questionnaire [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]
  7. Post-traumatic Stress Syndrome 10-question inventory (PTSS-10) [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]
  8. Behavioral Rating Inventory of Executive Function- Adult version (BRIEF-A) [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]
  9. Situational Fatigue scale [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]
  10. Brief Visual memory test (BVMT) [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]
    Test of visual learning and memory

  11. California Verbal Learning Test (CVLT) [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]
    Test of verbal learning and memory

  12. Digit-symbol, Wechsler Adult Intelligence Scale-IV [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]
    Test of psychomotor speed

  13. Color-Word interference test, Delis-Kaplan Test of Executive Function System [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]
    Test of executive functions

  14. Digit span, Wechsler Adult Intelligence Scale-IV [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]
    Test of working memory

  15. Grooved Pegboard [ Time Frame: Patients with an aSAH in 2011 will have their 5 years assessment in 2016 and 10 year assessment in 2021. Patients with an aSAH in 2012 will have their 5 year assessment in 2017 and 10 year assessment in 2022 ]
    Test of motor skills



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated for aSAH at Oslo University Hospital in 2011-2012
Criteria

Inclusion Criteria:

  • Patients with aSAH treated at Oslo University Hospital in 2011-2012
  • Only patients with signed informed consent form and thereby included the project "Effect of early rehabilitation in patients with acute subarachnoid hemorrhage" (Regional Committee for Medical Research Ethics, South-East Norway, archive number 2011/2189, Clinical Trials number 0925-0586, Clinical Trials gov. identifier NCT01656317) will be asked to participate.

Exclusion criteria:

  • Patients with aSAH treated at Oslo University Hospital in 2011-2012 who did not sign an informed consent form in the project "Effect of early rehabilitation in patients with acute subarachnoid hemorrhage" (Regional Committee for Medical Research Ethics, South-East Norway, archive number 2011/2189, Clinical Trials number 0925-0586, Clinical Trials gov. identifier NCT01656317)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795533


Locations
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Norway
Oslo University Hospital, Department of Physical medicine and rehabilitation
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Tonje Haug Nordenmark, PhD Oslo University Hospital
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Responsible Party: Tonje Haug Nordenmark, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02795533    
Other Study ID Numbers: 2016/422
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tonje Haug Nordenmark, Oslo University Hospital:
Cognitive function
Quality of Life
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases