Spinal Cord Injury Energy Management Program

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01184365
First received: August 11, 2010
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

Fatigue is a common complaint of persons with spinal cord injury (SCI) that negatively affects physical function, participation in daily activities, employment, and community involvement. No behavioural intervention for fatigue has been reported for SCI, though the benefits of such programs have been proven in persons with neurological conditions like multiple sclerosis and arthritis. Based on a study with people with SCI, an energy management program (EnMP-1) was developed. The focus of this study is to test EnMP-1. Adults with SCI living in the community and reporting fatigue as a problem will participate in the program.

Hypothesis: Participants in the EnMP-1 group will show significantly lower fatigue impact scores and higher self-efficacy scores immediately after, 3 months, and 6 months post-intervention than EnMP-2 participants.


Condition Intervention Phase
Spinal Cord Injury
Behavioral: Energy Management Program
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Spinal Cord Injury Energy Management Program

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • To test a behavioural (not pharmaceutical or surgical) intervention for fatigue in SCI [ Time Frame: Six months ] [ Designated as safety issue: No ]
    The primary outcome measure evaluates fatigue impact and is the Modified Fatigue Impact Scale (MFIS-SCI) which was originally developed for individuals with MS and was modified and tested by members of the research team in a study of fatigue in a sub-acute sample of individuals with SCI.


Secondary Outcome Measures:
  • Evaluates self-efficacy and is the Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA) [ Time Frame: Six months ] [ Designated as safety issue: No ]
    The measure consists of items regarding confidence in employing various means of energy conservation and is answered on a scale of 1-10, with one being not at all confident to ten being completely confident.


Enrollment: 28
Study Start Date: August 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EnMP-1
The goal of the EnMP-1 is to enable participants, through a behavioural, psycho-educational intervention, to better manage and understand their fatigue. This program is provided in four, two-hour sessions held weekly.
Behavioral: Energy Management Program
The program content over the four sessions is structured as follows: Session 1 is an introduction to the group, important concepts, and upcoming session topics; Session 2 further elaborates on the concepts introduced in session 1 and encourages self-reflection; Session 3 is the peer to peer contact by phone or in person to assist with problems and share tips that really worked; and Session 4 concludes the program and serves to consolidate information learned.
Active Comparator: EnMP-2
The goal of the EnMP-2 is to control for group effects
Behavioral: Energy Management Program
The goal of the EnMP-2 is to control for group effects

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • must reside in the community in the Lower Mainland of Vancouver, British Columbia, Canada
  • must be an adult (19-65 years old)
  • be English speaking
  • have a spinal cord injury and is living in the community
  • experiencing problems with managing energy that may or may not result in difficulty participating at home, work or in the community.

Exclusion Criteria:

  • have a severe brain injury that may prevent their participation in the study
  • have other conditions such as arthritis, multiple sclerosis, cancer, or anemia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184365

Locations
Canada, British Columbia
Blusson Spinal Cord Centre
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Susan J. Forwell, PhD, OT(C), FCAOT University of British Columbia
Study Director: William C. Miller, Dr. University of British Columbia
Study Director: Andrea Townson, Dr. University of British Columbia
Study Director: Karen Hammell, Dr. University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01184365     History of Changes
Other Study ID Numbers: H10-01037, NSP-104021
Study First Received: August 11, 2010
Last Updated: March 14, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
fatigue
energy management
spinal cord injury
self-efficacy
environment

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 20, 2014