Clinical trial NCT06239142: Understanding Mental Fatigue After Subarachnoid Hemorrhage
Official title: Mental Fatigue and Outcome After Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Mental Fatigue
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 64 patients where included in a primary study of the acute phase after subarachnoid hemorrhage. This study population consists of patients surviving up to 5 years after the SAB and eligible to assess for the presence of mental fatigue.

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.

The Glasgow Outcome Scale-Extended (GOSE)

The GOSE evaluates the patient's functional outcome and level of independence in eight different domains of daily living, including physical, cognitive, emotional, and social functioning. It was developed to classify patients after a traumatic or nontraumatic brain injury, allowing for comparisons of outcomes between patients. The scale ranges from death (1 point) to good recovery (8 points), with higher scores indicating better outcomes and higher levels of independence. A GOSE score of 8 indicates full recovery with only minor symptoms that do not affect activities of daily living (ADL). A GOSE score of ≥ 5 indicates that patients can independently manage their ADL and is used in studies to describe a favorable outcome 5,28.

Secondary Outcome Measures are the association between mental fatigue and GOSE, demographics, complications during the acute phase and loss of conscious at ictus.

Eligibility criteria: Inclusion Criteria:

* Patients having had a aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

* age\<18 years, patients having pacemaker

Primary outcomes:
measure: Mental fatigue
timeFrame: 5 years
measure: GOSE
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sahlgrenska Academy Gothenburg University Inst of Clinical sciences
name: Helena Odenstedt Herges, PhD
role: PRINCIPAL_INVESTIGATOR
References: