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CompletedNCT02795533Updated Nov 2, 2023

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

An observational study in Subarachnoid Hemorrhage, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-11-02.

Sponsored by Oslo University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
112
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Subarachnoid Hemorrhage

Keywords

  • Cognitive function
  • Quality of Life
03

In context

Subarachnoid Hemorrhage

521 studies on the registry are indexed under Subarachnoid Hemorrhage; 126 are open to participants now.

This study's enrollment of 112 is close to the median of 116 across 234 observational studies indexed under Subarachnoid Hemorrhage.

Browse Subarachnoid Hemorrhage studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 830 studies on the registry; 146 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated for aSAH at Oslo University Hospital in 2011-2012

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
112 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • BehavioralClinical 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.

06

What researchers measure

Primary outcomes

  1. The Rivermead Post Concussion Symptom Questionnaire (RPQ)

    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

Secondary outcomes

  1. Short Form Health Survey (SF-36)

    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

  2. Fatigue Severity Scale (FSS)

    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

  3. Mental Fatigue Scale (MFS)

    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

  4. Behavioral Rating Inventory of Executive Function- Adult version (BRIEF-A)

    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

  5. California Verbal Learning Test (CVLT)

    Test of verbal learning and memory

    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. Color-Word interference test, Delis-Kaplan Test of Executive Function System

    Test of executive functions

    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. Digit span, Wechsler Adult Intelligence Scale-IV

    Test of working memory

    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. Mini Mental Status Examination (MMSE-NR3)

    Test

    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. Breif Visual Memory Test

    Test of visual memory

    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. Grooved Pegboard

    Test of motor skills

    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

07

Study locations

1 site
  • Oslo University Hospital, Department of Physical medicine and rehabilitation
    Oslo, 0424, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2016 to primary completion in Jun 2023, 84 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2016
First posted
Jun 10, 2016
StartActual
Jun 2016
Primary completionActual
Jun 2023
CompletionActual
Aug 2023
Last update
Nov 2, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02795533
Responsible party
Tonje Haug Nordenmark (PhD, Oslo University Hospital) — Principal investigator
First posted
Jun 10, 2016
Start date
Jun 2016
Primary completion
Jun 2023
Completion
Aug 2023
Last update
Nov 2, 2023

Study contacts

Tonje Haug Nordenmark, PhD
principal investigator · Oslo University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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