Poststroke Fatigue - Developing and Testing a Program to Reduce and Cope With Fatigue
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Central Denmark Region
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Aarhus, Central Denmark Region, Danmark, 8000
- Department of Neurology, Aarhus University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Lifestyle counseling
Testing of the teory- and evidence based health promotion program.
Patients will participate in a 13 weeks program.
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A 13 weeks organized program:
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Multidimensional Fatigue Inventory 20
Tidsramme: Change from baseline in MFI-20 at 3 and 6 months
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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.
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Change from baseline in MFI-20 at 3 and 6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The general self-efficacy scale
Tidsramme: Change from baseline in the generel self-efficacy scale at 3 and 6 months
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The general self-efficacy scale is a scale measuring how individuals cope with distressing situations
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Change from baseline in the generel self-efficacy scale at 3 and 6 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Marit Kirkevold, Professor, University of Aarhus, Health, Nursing Science
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TEA2011
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