Spinal Cord Injury Energy Management Program
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      Detailed Description Extended description of the protocol (Background, purpose, hypothesis,
      and inclusion/exclusion criteria already contained in other fields):

      The protocol subjects will follow is conceptualized into three periods: the pre-program
      phase, the program phase of either the EnMP-1 or the EnMP-2, and the follow-up phase.

      Pre-program Phase: Potential subjects will contact the Research Coordinator to volunteer for
      the study and to have any questions addressed. At that time, subjects will be screened by
      phone or in person using a Participant Screening Questionnaire to ensure that they meet the
      inclusion/exclusion criteria of the study. If the individual is deemed eligible, the Research
      Coordinator will gather demographic information and provide or forward the participant the
      pre-program preparation package that includes: a fact sheet about the study; the consent
      form; self-reported study measures (one primary for fatigue, one secondary for self-efficacy,
      and four co-variate measures assessing depression, pain, and sleep); and a self-addressed,
      stamped return envelope. Participants will be contacted one week after the pre-program
      package has been sent, to address questions and to verbally assist in completing the outcome
      measures, if required. They will be asked to sign the consent form, complete the study
      measures and return these in the envelope provided in the package.

      Four weeks later (one-week before the program phase) subjects will be forwarded the study
      measures to complete prior to the first session. Subjects will be contacted 1-2 days before
      the first session to address concerns, clarify that measures are to be completed and brought
      to the first session, and to remind subjects of the date, time and location of the first
      session. Subjects who received the workbook will be encouraged to browse and review its
      content. The study measures will be collected at the beginning of the first session.

      Program Phase: All subjects will participate in the four, two-hour sessions held one week
      apart for four weeks.

      The program content for both the EnMP-1 and EnMp-2 group 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.

      At the conclusion of the week-four session, subjects will be provided with a package that
      includes the study measures, a program evaluation and self-addressed stamped envelope. They
      will be asked to complete the measures and the evaluation over next week and return them in
      the envelope provided. Subjects will be contacted 1-2 days after this last session to address
      questions and to remind them to return the measures and program evaluation in the envelope
      provided. After one-week, if the package has not been received, subjects will be contacted to
      assist with any issues and to encourage return of the package. This will be repeated one
      further time to maximize return.

      Follow-up Phase: After the program phase is concluded, there will be a six-month follow-up.
      Subjects will be forwarded the self-report study measures and self-addressed stamped envelope
      and asked to complete and return them in the envelope provided. Subjects will be contacted
      one week after the package is sent to address questions and to remind them to return the
      measures in the envelope provided. If the package has not been received, after another week,
      subjects will be contacted to assist with any issues and to encourage return of the package.
      This will be repeated one further time, a week later, to maximize return.

      The time commitment for participating in this study is between 11-12 hours over 7 months.
    

Intervention name(s): Energy Management Program; Energy Management Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; The goal of the EnMP-2 is to control for group effects
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: fatigue; energy management; spinal cord injury; self-efficacy; environment