Poststroke Fatigue - Developing and Testing a Program to Reduce and Cope With Fatigue

NCT01629654 | Completed

• 1 other identifier: TEA2011
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Fatigue is a common complaint after stroke, reported by 39-72% of patients. Poststroke fatigue is related to poor neurological recovery, low level of activities of daily living, decreased quality of life and may possibly affect the ability to return to work. Little is known about strategies addressing post-stroke fatigue and their effectiveness. Aim: to develop, test and evaluate a health promotion program based on strategies addressing poststroke fatigue.

Conditions

Cardiovascular Disease; Stroke

Keywords

Poststroke fatigue; Health promotion; Patient education

Outcome Measures

Primary Outcomes (1)

• Multidimensional Fatigue Inventory 20

  The multidimensional Fatigue Inventory 20 is a multidimensional fatigue score covering five dimensions of fatigue: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Activity. Pathologic Fatigue is defined as a score ≥ 12 on the General Fatigue dimension.

  Change from baseline in MFI-20 at 3 and 6 months

Secondary Outcomes (1)

• The general self-efficacy scale

  Change from baseline in the generel self-efficacy scale at 3 and 6 months

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL

Testing of the teory- and evidence based health promotion program. Patients will participate in a 13 weeks program.

Behavioral: Health promotion program

Interventions

Health promotion program BEHAVIORAL

A 13 weeks organized program: * One group session about poststroke fatigue involving both patient and relatives * Two personal meetings, involving both patient and relatives * Three telephone meetings, involving only patient

Also known as: Poststroke fatigue, Complex interventions

Lifestyle counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with first ever stroke
• \> 18 year
• Living in the area of Aarhus(intervention group) and patients living in the area of Holstebro (control group).
• Multidimensional Fatigue Inventory-20/Generel Fatigue \> 12.
• The patient must be able to give informed consent
• Walking without person support.
• Walking aids is accepted.

You may not qualify if:

• Neurological problems related to acute stroke(severe aphasia, decreased level of conscience or decreased attention)
• Other neurologic or psychiatric deseases (including dementia, non treated depression, misuse of alcohol eller medicin)
• Severe co-morbidity (including cancer, blindness or deathness)
• Not-danish speaking.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• The Novo Nordic Foundation: collaborator
• Aase and Ejnar Danielsens Foundation: collaborator

Study Sites (1)

Department of Neurology, Aarhus University Hospital

Aarhus, Central Jutland, 8000, Denmark

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Marit Kirkevold, Professor

  University of Aarhus, Health, Nursing Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: June 27, 2012
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 27, 2012

Record last verified: 2012-06

Locations

DK (1)