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

June 25, 2012 updated by: University of Aarhus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Central Denmark Region
      • Aarhus, Central Denmark Region, Denmark, 8000
        • Department of Neurology, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Poststroke fatigue
  • Complex interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multidimensional Fatigue Inventory 20
Time Frame: Change from baseline in MFI-20 at 3 and 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The general self-efficacy scale
Time Frame: Change from baseline in the generel self-efficacy scale at 3 and 6 months
The general self-efficacy scale is a scale measuring how individuals cope with distressing situations
Change from baseline in the generel self-efficacy scale at 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
The Novo Nordic Foundation
Aase and Ejnar Danielsens Foundation

Investigators

  • Principal Investigator: Marit Kirkevold, Professor, University of Aarhus, Health, Nursing Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

January 20, 2012

First Submitted That Met QC Criteria

June 25, 2012

First Posted (Estimate)

June 27, 2012

Study Record Updates

Last Update Posted (Estimate)

June 27, 2012

Last Update Submitted That Met QC Criteria

June 25, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEA2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Health promotion program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe