Emotional and Cognitive Determinants of Post-stroke Fatigue

NCT03639259 | Completed

• 1 other identifier: 2017/1966 (REC)
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Fatigue; Post-Stroke Fatigue; Neuropsychology; Cognitive Impairment; Quality of Life; Post-stroke Depression; Meta-cognition

Outcome Measures

Primary Outcomes (1)

• Presence of post-stroke fatigue as measured with the Fatigue Severity Scale (FSS).

  The primary outcome of this study is presence of fatigue after stroke, measured with the Fatigue Severity Scale (FSS). FSS includes 9 items related to fatigue graded on a 7-point Likert-like scale ranging from 1 ("disagreeable") to 7 ("highly agreeable"). The minimum score=9 and maximum score possible=63. Higher score=greater fatigue severity. The average score for all 9 items constitute the FSS score.

  3-4 years after stroke

Secondary Outcomes (2)

• Post-stroke fatigue measured with the Chalder Fatigue Questionnaire (CFQ)

  3-4 years after stroke

• Participants' degree of stroke-specific quality of life measured by the Stroke-Specific Quality of Life Scale (SSQOL).

  3-4 years after stroke

Other Outcomes (5)

• Degree of cognitive impairment after stroke as measured with neuropsychological tests.

  3-4 years after stroke

• Self-reported symptoms of anxiety and depression as measured with the Hospital Anxiety and Depression Scale (HADS).

  3 months after stroke, 12 months after stroke, and 3-4 years after stroke.

• Metacognitive thinking style measured using the Metacognitions Questionnaire (MCQ-30).

  3-4 years after stroke

Study Arms (1)

Post-stroke fatigue

Participants fulfilling criteria for presence of fatigue after cerebral stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• No diagnosis of cerebral stroke given
• Not functionally able to undergo neuropsychological assessment or reply to questionnaires.

Sponsors & Collaborators

• University Hospital of North Norway: lead
• Norwegian Extra Foundation for Health and Rehabilitation: collaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, 9016, Norway

Location

MeSH Terms

Conditions

Stroke; Fatigue; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Audny Anke, Professor

  Univerity Hospital of North Norway (UNN)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 21, 2018
• Study Start: May 30, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

NO (1)