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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Central Denmark Region
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Aarhus, Central Denmark Region, 덴마크, 8000
- Department of Neurology, Aarhus University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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:
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Multidimensional Fatigue Inventory 20
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The general self-efficacy scale
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Marit Kirkevold, Professor, University of Aarhus, Health, Nursing Science
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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