Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06239142 |
| Other study ID # |
SAH I |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2015 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Sahlgrenska University Hospital, Sweden |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
