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

Primary Purpose

Cardiovascular Disease, Stroke

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Health promotion program
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Disease focused on measuring Poststroke fatigue, Health promotion, Patient education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Neurology, Aarhus University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle counseling

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The general self-efficacy scale
The general self-efficacy scale is a scale measuring how individuals cope with distressing situations

Full Information

First Posted
January 20, 2012
Last Updated
June 25, 2012
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, The Novo Nordic Foundation, Aase and Ejnar Danielsens Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01629654
Brief Title
Poststroke Fatigue - Developing and Testing a Program to Reduce and Cope With Fatigue
Official Title
Poststroke Fatigue - Developing and Testing a Program to Reduce and Cope With Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, The Novo Nordic Foundation, Aase and Ejnar Danielsens Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Stroke
Keywords
Poststroke fatigue, Health promotion, Patient education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
Testing of the teory- and evidence based health promotion program. Patients will participate in a 13 weeks program.
Intervention Type
Behavioral
Intervention Name(s)
Health promotion program
Other Intervention Name(s)
Poststroke fatigue, Complex interventions
Intervention Description
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
Primary Outcome Measure Information:
Title
Multidimensional Fatigue Inventory 20
Description
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.
Time Frame
Change from baseline in MFI-20 at 3 and 6 months
Secondary Outcome Measure Information:
Title
The general self-efficacy scale
Description
The general self-efficacy scale is a scale measuring how individuals cope with distressing situations
Time Frame
Change from baseline in the generel self-efficacy scale at 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marit Kirkevold, Professor
Organizational Affiliation
University of Aarhus, Health, Nursing Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Aarhus University Hospital
City
Aarhus
State/Province
Central Denmark Region
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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

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