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

Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02795533
• Other study ID #: 2016/422
• Status: Completed
• Start date: June 2016
• Est. completion date: August 2023

Study information

• Verified date: October 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Behavioral:
• Clinical follow-up
All included patients will have a clinical follow-up consisting of: A medical examination Quality of life questionnaires Neuropsychological test All instruments have been translated into Norwegian and validated and tested in clinical practice.

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Department of Physical medicine and rehabilitation	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Rivermead Post Concussion Symptom Questionnaire (RPQ)	Questionnaire	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	Short Form Health Survey (SF-36)	Questionnaire	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	Fatigue Severity Scale (FSS)	Questionnaire	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	Mental Fatigue Scale (MFS)	Questionnaire	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	Behavioral Rating Inventory of Executive Function- Adult version (BRIEF-A)	Questionnaire	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	California Verbal Learning Test (CVLT)	Test of verbal learning and memory	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	Color-Word interference test, Delis-Kaplan Test of Executive Function System	Test of executive functions	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	Digit span, Wechsler Adult Intelligence Scale-IV	Test of working memory	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	Mini Mental Status Examination (MMSE-NR3)	Test	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	Breif Visual Memory Test	Test of visual memory	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	Grooved Pegboard	Test of motor skills	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