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

25. juni 2012 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

41

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lifestyle counseling
Testing of the teory- and evidence based health promotion program. Patients will participate in a 13 weeks program.
Adfærdsmæssigt: 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
Andre navne:
  • Poststroke fatigue
  • Complex interventions

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Multidimensional Fatigue Inventory 20
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The general self-efficacy scale
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Aarhus

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Marit Kirkevold, Professor, University of Aarhus, Health, Nursing Science

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2011

Primær færdiggørelse (Faktiske)

1. marts 2012

Studieafslutning (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først indsendt

20. januar 2012

Først indsendt, der opfyldte QC-kriterier

25. juni 2012

Først opslået (Skøn)

27. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. juni 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2012

Sidst verificeret

1. juni 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TEA2011

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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