Poststroke Fatigue - Developing and Testing a Program to Reduce and Cope With Fatigue
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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 |
- 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.
- 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:
Other Names:
|
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 |
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| Denmark | |
| Department of Neurology, Aarhus University Hospital | |
| Aarhus, Central Denmark Region, Denmark, 8000 | |
| 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 Stroke Signs and Symptoms Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013