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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Health promotion program Behavioral
    Other Names: Health promotion program; Poststroke fatigue; Complex interventions
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Lifestyle counseling
    Description: Testing of the teory- and evidence based health promotion program. Patients will participate in a 13 weeks program.

Trial Design

  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Prevention
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Multidimensional Fatigue Inventory 20 Change from baseline in MFI-20 at 3 and 6 months No
Secondary The general self-efficacy scale Change from baseline in the generel self-efficacy scale at 3 and 6 months No

Sponsors