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

NCT02795533 | Completed

• 1 other identifier: 2016/422
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage

Keywords

Cognitive function; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Short Form Health Survey (SF-36)

  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)

  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)

  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)

  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

• California Verbal Learning Test (CVLT)

  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

Study Arms (1)

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

Clinical follow-up BEHAVIORAL

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.

Clinical follow-up

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Department of Physical medicine and rehabilitation

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tonje Haug Nordenmark, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 10, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)