Clinical trial NCT01629654: Poststroke Fatigue - Developing and Testing a Program to Reduce and Cope With Fatigue
Official title: Poststroke Fatigue - Developing and Testing a Program to Reduce and Cope With Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Stroke
Keywords: Poststroke fatigue
Health promotion
Patient education
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: The Novo Nordic Foundation
name: Aase and Ejnar Danielsens Foundation
First posted: 2012-06-27
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Multidimensional Fatigue Inventory 20
timeFrame: Change from baseline in MFI-20 at 3 and 6 months
Secondary outcomes:
measure: The general self-efficacy scale
timeFrame: Change from baseline in the generel self-efficacy scale at 3 and 6 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Neurology, Aarhus University Hospital
state: Central Denmark Region
Study officials:
affiliation: University of Aarhus, Health, Nursing Science
name: Marit Kirkevold, Professor
role: PRINCIPAL_INVESTIGATOR
References: