Spinal Cord InjuryPhase 2/3NCT01184365
Spinal Cord Injury Energy Management Program
A Phase 2/3 study testing Energy Management Program in people with Spinal Cord Injury, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Energy Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2010to Jun 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- have a severe brain injury that may prevent their participation in the study
- have other conditions such as arthritis, multiple sclerosis, cancer, or anemia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Energy Management Program
- Keywords
- fatigue, energy management, spinal cord injury, self-efficacy, environment
- Medical subject headings
- Spinal Cord Injuries, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy Management ProgramBehavioural
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.
Energy Management ProgramBehavioural
The goal of the EnMP-2 is to control for group effects
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Energy Management Program |
| EnMP-2 | Active comparator | The goal of the EnMP-2 is to control for group effects Receives: Behavioral: Energy Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (1)
Evaluates self-efficacy and is the Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Susan J. Forwell, PhD, OT(C), FCAOT, Principal investigator, University of British ColumbiaWilliam C. Miller, Dr., Study director, University of British ColumbiaAndrea Townson, Dr., Study director, University of British ColumbiaKaren Hammell, Dr., Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184365
- Sponsor's protocol ID
- H10-01037
- Other IDs
- NSP-104021
- Status last verified
- Mar 2014
- First submitted
- 11 Aug 2010
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Injury Energy Management Program
- ClinicalTrials.gov ID
- NCT01184365
- Acronym / sponsor ID
- H10-01037
- Conditions
- Spinal Cord Injury
- Keywords
- fatigue, energy management, spinal cord injury, self-efficacy, environment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EnMP-1 | Experimental | Behavioral: Energy Management ProgramThe 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. |
| EnMP-2 | Active comparator | Behavioral: Energy Management ProgramThe goal of the EnMP-2 is to control for group effects |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- have a severe brain injury that may prevent their participation in the study
- have other conditions such as arthritis, multiple sclerosis, cancer, or anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy Management ProgramThe 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. | Behavioural | EnMP-1 |
| Energy Management ProgramThe goal of the EnMP-2 is to control for group effects | Behavioural | EnMP-2 |
Primary outcome
To test a behavioural (not pharmaceutical or surgical) intervention for fatigue in SCI
Time frame: Six months
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.
1 secondary outcome
Evaluates self-efficacy and is the Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan J. Forwell, PhD, OT(C), FCAOT principal investigator
University of British Columbia
William C. Miller, Dr. study director
University of British Columbia
Andrea Townson, Dr. study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Energy Management Program in people with Spinal Cord Injury, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test a behavioural (not pharmaceutical or surgical) intervention for fatigue in SCI (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2014.