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

NCT ID: NCT02795533

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Subarachnoid Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Clinical follow-up

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tonje Haug Nordenmark

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tonje Haug Nordenmark, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital, Department of Physical medicine and rehabilitation

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2016/422

Identifier Type: -

Identifier Source: org_study_id

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