Spinal Cord Injury Energy Management Program

NCT01184365 | Completed Phase 2

• 2 other identifiers: H10-01037NSP-104021
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injury

Keywords

fatigue; energy management; spinal cord injury; self-efficacy; environment

Outcome Measures

Primary Outcomes (1)

• To test a behavioural (not pharmaceutical or surgical) intervention for fatigue in SCI

  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.

  Six months

Secondary Outcomes (1)

• Evaluates self-efficacy and is the Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)

  Six months

Study Arms (2)

EnMP-1

EXPERIMENTAL

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

EnMP-2

ACTIVE COMPARATOR

The goal of the EnMP-2 is to control for group effects

Behavioral: Energy Management Program

Interventions

Energy Management Program BEHAVIORAL

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.

EnMP-1

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• have a severe brain injury that may prevent their participation in the study
• have other conditions such as arthritis, multiple sclerosis, cancer, or anemia

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Blusson Spinal Cord Centre

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Fatigue

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan J. Forwell, PhD, OT(C), FCAOT

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 18, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

CA (1)