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

This study has been completed.
Sponsor:
Collaborators:
Aarhus University Hospital
The Novo Nordic Foundation
Aase and Ejnar Danielsens Foundation
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01629654
First received: January 20, 2012
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Stroke
Behavioral: Health promotion program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Poststroke Fatigue - Developing and Testing a Program to Reduce and Cope With Fatigue

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Multidimensional Fatigue Inventory 20 [ Time Frame: Change from baseline in MFI-20 at 3 and 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The general self-efficacy scale [ Time Frame: Change from baseline in the generel self-efficacy scale at 3 and 6 months ] [ Designated as safety issue: No ]
    The general self-efficacy scale is a scale measuring how individuals cope with distressing situations


Enrollment: 41
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling
Testing of the teory- and evidence based health promotion program. Patients will participate in a 13 weeks program.
Behavioral: Health promotion program

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
Other Names:
  • Health promotion program
  • Poststroke fatigue
  • Complex interventions

Detailed Description:

Fatigue is a common complaint after stroke, reported by 39-72% of patients. It has been shown that poststroke fatigue may be related to poor neurological recovery, low level of activities of daily living and decreased quality of life. However, little is known about strategies to address poststroke fatigue and the effectiveness of such strategies.

Objective The aim of the study is to develop a program based on strategies to address poststroke fatigue and to test and evaluate the program.

Material and Methods Intervention Mapping is the overall approach of the study. It describes a protocol for the development of theory- and evidence-based health promotion programmes.

Step 1) The program is developed based on a needs assessment. Existing knowledge about physical, psychosocial and environmental factors associated with poststroke fatigue is mapped in a literature review.

Step 2) The program will be tested in a pilot study (controlled trial). In addition to conventional treatment, the patients in the intervention group will participate in the program for a period of 12 weeks. The control group will receive conventional treatment only.

Step 3) Evaluation of the program: Primary outcome measure will be fatigue, measured on the Multidimensional Fatigue Inventory-20. Secondary outcome measures will be identified during the development of the program. Patients will be tested at baseline, after 3 months and after 6 months. The effect size in the pilot study will be assessed and will be used in order to estimate the required sample size for a large-scale randomized controlled trial on formally testing the efficacy of the program.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629654

Locations
Denmark
Department of Neurology, Aarhus University Hospital
Aarhus, Central Denmark Region, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
The Novo Nordic Foundation
Aase and Ejnar Danielsens Foundation
Investigators
Principal Investigator: Marit Kirkevold, Professor University of Aarhus, Health, Nursing Science
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01629654     History of Changes
Other Study ID Numbers: TEA2011
Study First Received: January 20, 2012
Last Updated: June 25, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Poststroke fatigue
Health promotion
Patient education

Additional relevant MeSH terms:
Cardiovascular Diseases
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014