Clinical trial NCT03639259: Emotional and Cognitive Determinants of Post-stroke Fatigue
Official title: Emotional and Cognitive Determinants of Post-stroke Fatigue. A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Fatigue
Post-Stroke Fatigue
Neuropsychology
Cognitive Impairment
Quality of Life
Post-stroke Depression
Meta-cognition
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Norwegian Extra Foundation for Health and Rehabilitation
First posted: 2018-08-21
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients included in this study are the norwegian cohort of the study "Rehabilitation, function and quality of life after cerebral stroke in North Norway and Denmark". Data collection for the first year after stroke is completed. This new study will consist of a follow up of norwegian participants 3 years after stroke and includes assessment of neuropsychological functions, fatigue, emotional problems, physical activity and sleep pattern, and quality of life.

Brief summary: Fatigue is a prevalent, prolonged and partly disabling symptom following cerebral stroke. The health services has little knowledge of fatigue, both in terms of what characterizes those affected, and with regard to how fatigue can be treated. Persons going through a stroke may experience impairments in cognitive functions such as attention and memory. This will often cause previously effortless activities of daily living to become strenuous and exhausting. Experiencing a stroke will also in many cases lead to a major change in life due to other related loss of function, grief and health-related concerns. Emotional reactions like depression and anxiety are widespread.

Specific knowledge of how cognitive impairment, emotional reactions and coping strategies contribute to development and maintenance of fatigue is lacking. The present research project will contribute with new and important knowledge in this area.

A total of 250 adults have been followed up after stroke with multiple examinations. Average age at the time of stroke was 70 years. The investigators now plan to follow them up three to four years after stroke. This provides a unique opportunity to investigate how depression and anxiety, over time, may be related to the experience of fatigue, cognitive impairment and negative coping strategies such as worrying and rumination. The investigators will use questionnaires and cognitive tests when examining these associations. Such new knowledge about cognitive and emotional factors related to the development of fatigue long-term after stroke may help determine who is at risk of developing symptoms of fatigue. Furthermore, it can shed light on possible preventional measures, and provide better suited advice to those affected by fatigue. This knowledge can also pave the way for new, research-based treatment methods.

Detailed description: Fatigue is a common symptom after stroke experienced by 25% - 92%. Fatigue predicts reduced physical health and has a negative impact on everyday life. Causes are poorly investigated and not fully understood. Recent studies indicate that specific cognitive functions are related to the development of fatigue, but findings are not consistent. There are few studies with adequate neuropsychological tests and an adequate number of participants. Moreover, it is not clear whether anxiety or depression may predict later occurrence of fatigue after stroke, or how coping strategies affect the process.

The purpose of this study is to investigate 1) the association between cognitive factors as measured with neuropsychological tests and fatigue 3-4 years after cerebral stroke, 2) whether emotional factors 3 and 12 months after stroke predict development of fatigue long-term (3-4 years) after stroke, and 3) the association between fatigue and different domains of stroke-specific health-related quality of life 3-4 years after the stroke. Metacognitive thinking style are treated as a possible mediator of the association of depression/anxiety and fatigue after stroke. Physical activity and sleep measured with accelerometer are treated as mediators of the association of both emotional and cognitive factors and fatigue.

Identification of factors relevant to the development of fatigue, and increased knowledge of the consequences of fatigue for health-related quality of life, will provide greater understanding of mechanisms, contribute to early identification of fatigue, and better adapted rehabilitation; and thereby increased function and quality of life.

The following articles will be published as part of this project:

1. The association between cognitive functioning and fatigue long-term post-stroke. A cross-sectional study with neuropsychological tests.
2. Anxiety and depression as predictors for long-term fatigue after stroke. A prospective study.
3. Metacognitions and thought control strategies in patients with post stroke fatigue.
4. The association between fatigue and health-related quality of life. A prospective study.

Eligibility criteria: Inclusion Criteria:

* Verified cerebral stroke
* Admitted to a stroke unit at the University Hospital of North Norway in the cities of Tromsø, Harstad or Narvik during 2014-2015.

Exclusion Criteria:

* No diagnosis of cerebral stroke given
* Diagnosed with one or more strokes since inclusion after verified stroke in 2014/2015.
* Not functionally able to undergo neuropsychological assessment or reply to questionnaires.

Primary outcomes:
measure: Presence of post-stroke fatigue as measured with the Fatigue Severity Scale (FSS).
timeFrame: 3-4 years after stroke
Secondary outcomes:
measure: Post-stroke fatigue measured with the Chalder Fatigue Questionnaire (CFQ)
timeFrame: 3-4 years after stroke
measure: Participants' degree of stroke-specific quality of life measured by the Stroke-Specific Quality of Life Scale (SSQOL).
timeFrame: 3-4 years after stroke
Other outcomes:
measure: Degree of cognitive impairment after stroke as measured with neuropsychological tests.
timeFrame: 3-4 years after stroke
measure: Self-reported symptoms of anxiety and depression as measured with the Hospital Anxiety and Depression Scale (HADS).
timeFrame: 3 months after stroke, 12 months after stroke, and 3-4 years after stroke.
measure: Metacognitive thinking style measured using the Metacognitions Questionnaire (MCQ-30).
timeFrame: 3-4 years after stroke
measure: Physical activity
timeFrame: 3-4 years post-stroke
measure: Sleep pattern
timeFrame: 3-4 years post-stroke
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: Univerity Hospital of North Norway (UNN)
name: Audny Anke, Professor
role: PRINCIPAL_INVESTIGATOR
References: