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

NCT ID: NCT01629654

Last Updated: 2012-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-06-30

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.

Conditions

Cardiovascular Disease; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Lifestyle counseling

Testing of the teory- and evidence based health promotion program. Patients will participate in a 13 weeks program.

Group Type: EXPERIMENTAL

Health promotion program

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Poststroke fatigue; Complex interventions

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

The Novo Nordic Foundation

OTHER

Sponsor Role: collaborator

Aase and Ejnar Danielsens Foundation

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marit Kirkevold, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus, Health, Nursing Science

Locations

Department of Neurology, Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Countries

Denmark

Other Identifiers

TEA2011

Identifier Type: -

Identifier Source: org_study_id