Skip to main content
Clinical Trials/NCT06239142
NCT06239142Active, not recruitingNot Applicable

Mental Fatigue and Outcome After Subarachnoid Hemorrhage

Sahlgrenska University Hospital, Sweden0 sites64 target enrollmentStarted: May 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
64
Primary Endpoint
Mental fatigue

Study Overview

Brief Summary

Fatigue is among the most frequently reported sequelae in stroke survivors. For a specific stroke diagnosis, aneurysmal subarachnoid hemorrhage (aSAH), fatigue, in general, is reported to be present in 30 to 90% of the patients. It is the mental fatigue component that significantly contributes to difficulties that patients with aSAH face when returning to normal life. However, there is substantial variation in the reported incidence of mental fatigue (25%-60%), which may be attributed to several methodological factors, such as differences in the follow-up periods and instruments used. Consequently, a complete understanding of how mental fatigue influences long-term recovery remains elusive. This research project will contribute to new and important knowledge in long-term effects after SAH when it comes to mental fatigue.

In this study patients surviving an SAH will be assessed for mental fatigue at 5 years after the insult. The patients have previously been assessed at 1 and 3 years. All patients have been treated at Sahlgrenska University Hospital during the acute phase after SAH. Follow-up is performed after 5 years after aSAH through a structured telephone interview, where patients are scored using the Glasgow Outcome Scale-Extended (GOSE) Additionally, the patients receive a self-assessment questionnaire, the Mental Fatigue Scale, Patients are reminded to return the questionnaires at three times.

This study aims to determine the long-term prevalence, severity, and dynamics of mental fatigue at 1, 3, and 5 years after an aSAH. The study also aims to identify whether demographic characteristics and secondary complications or diagnoses after aSAH can be associated with an increased risk of developing mental fatigue or unfavourable outcome.

Detailed Description

In this study patients surviving an SAH will be assessed for mental fatigue at 5 years after the insult. The patients have previously been assessed at 1 and 3 years. All patients have been treated at Sahlgrenska University Hospital during the acute phase after SAH. Follow-up is performed after 5 years after aSAH through a structured telephone interview, where patients are scored using the Glasgow Outcome Scale-Extended (GOSE) Additionally, the patients receive a self-assessment questionnaire, the Mental Fatigue Scale, Patients are reminded to return the questionnaires at three times.

Primary outcome measure:

The Mental Fatigue Scale (MFS)score

The MFS is a multidimensional self-reporting questionnaire developed for assessing different aspects of mental fatigue in patients with brain injuries. It comprises 15 items regarding fatigue, including lack of initiative; mental recovery; concentration difficulties; memory problems; slowness of thinking; sensitivity to stress; increased mental fatigue, increased tendency to become emotional; irritability; sensitivity to light and noise; and decreased or increased sleep duration. Each item has four response options ranging from 0 (normal function) to 3 (maximal problems); further, one can select response points in between (i.e., 0,5, 1,5, and 2,5), which yields a total of seven options. Items 1-14 are used to calculate the total score, with a maximum score of 42. We did not include item 15, which assesses 24-h variations, in the total score, but it can be used in clinical practice. An MFS score ≥ 10.5 indicates mental fatigue. A higher MFS score indicates more severe problems.

This study explores the presence, severity and dynamics of mental fatigue.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients having had a aneurysmal subarachnoid hemorrhage

Exclusion Criteria

  • age<18 years, patients having pacemaker

Outcomes

Primary Outcomes

Mental fatigue

Time Frame: 5 years

Mental fatigue scale score. The instrument consists of 15 questions addressing different problems within the fatigue area and problems can be graded by the patient in 7 steps according to severity. Maximum score is 30 and a value above 10.5 indicates the presence of mental fatigue.

GOSE

Time Frame: 5 years

extended Glascow outcome scale. Describing functional outcome according to an 8-grdaed scale where 1 corresponds to dead and 8 to fully recovered.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sahlgrenska University Hospital, Sweden
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Helena Odenstedt Hergès

Associate professor

Sahlgrenska University Hospital, Sweden

Similar Trials