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

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.

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage
• Intervention / Treatment: Behavioral: Clinical follow-up

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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: A medical examination; Quality of life questionnaires; Neuropsychological test All instruments have been translated into Norwegian and validated and tested in clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Tonje Haug Nordenmark, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (Estimated): June 10, 2016

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Cognitive function
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: 2016/422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO