Spinal Cord InjurySCI-CareNCT02026167
Spinal Cord Injury Collaborative Care Study
A study testing Collaborative Care in people with Spinal Cord Injury, run by University of Washington.
Trial summary
The objective of this study is to test the effectiveness of a collaborative care approach to improving outpatient treatment for inactivity, chronic pain and depression as a way of improving overall Quality of Life for patients with SCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Collaborative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Jun 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- diagnosis of traumatic spinal cord injury by medical record review
- receives primary SCI care from a provider at the University of Washington or Harborview Medical Center's Rehabilitation Outpatient Clinic
- positive screening for pain related to SCI diagnosis and/or
- positive screening for low mood and/or
- negative screening for physical activity levels
- able to speak and understand English
Who cannot join
- psychiatric condition that would interfere with participation
- major surgery in the next 8 months
About this study
Official title: SCI-CARE (Northwest Regional Spinal Cord Injury Site Specific Project)
The objective of this study is to test the effectiveness of a collaborative care approach to improving outpatient treatment for inactivity, chronic pain and depression as a way of improving overall Quality of Life for patients with SCI.
Read the detailed description
Individuals with SCI were treated by a care manager who worked in collaboration with the participant's physician to decrease pain, decrease depression symptoms, and/or to increase physical activity. This was done by collaborating on current treatments to make sure that they are being as effective as possible and by providing non-pharmacological treatments.
- Conditions
- Spinal Cord Injury
- Being tested
- Collaborative Care
- Keywords
- Chronic Pain, Mood, Physical Activity
- Medical subject headings
- Spinal Cord Injuries, Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative CareBehavioural
Addition of a Health Care Assistant to treatment team, case review by expert panel of supervisors, non-medical interventions
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | No intervention, usual care |
| Intervention | Experimental | Collaborative care with Health Care Assistant Receives: Behavioral: Collaborative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life
Quality of Life is assessed via telephone interviews at baseline and 4 months.
Measured: Baseline, 4 months
Secondary outcomes (5)
Change in Pain
Pain is assessed via telephone interview at baseline, 4 months, and 8 months.
Measured: Baseline, 4 months, 8 months
Change in Mood
Mood assessed via telephone interviews at baseline, 4 months, and 8 months.
Measured: Baseline, 4 months, 8 months.
Change in Physical Activity
Physical activity is assess via telephone interview at baseline, 4 months, and 8 months.
Measured: Baseline, 4 months, 8 months
Change in Quality of Life
Change in QOL from baseline to 8 months will be compared between groups
Measured: Baseline, 8 months
Adverse events
The number of cases with serious or non-serious adverse events in the two arms
Measured: baseline to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startDec 2012
- Primary completionJun 2016
- Study completionJun 2016
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 WashingtonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, Charles Bombardier, University of Washington
- Investigators
- Charles H Bombardier, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026167
- Sponsor's protocol ID
- STUDY00001791
- Acronym
- SCI-Care
- Status last verified
- Feb 2019
- First submitted
- 26 Dec 2013
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCI-CARE (Northwest Regional Spinal Cord Injury Site Specific Project)
- ClinicalTrials.gov ID
- NCT02026167
- Acronym / sponsor ID
- SCI-Care / STUDY00001791
- Conditions
- Spinal Cord Injury
- Keywords
- Chronic Pain, Mood, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Dec 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Jan 2014 (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.
The objective of this study is to test the effectiveness of a collaborative care approach to improving outpatient treatment for inactivity, chronic pain and depression as a way of improving overall Quality of Life for patients with SCI.
Detailed description
Individuals with SCI were treated by a care manager who worked in collaboration with the participant's physician to decrease pain, decrease depression symptoms, and/or to increase physical activity. This was done by collaborating on current treatments to make sure that they are being as effective as possible and by providing non-pharmacological treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –No intervention, usual care |
| Intervention | Experimental | Behavioral: Collaborative CareCollaborative care with Health Care Assistant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- diagnosis of traumatic spinal cord injury by medical record review
- receives primary SCI care from a provider at the University of Washington or Harborview Medical Center's Rehabilitation Outpatient Clinic
- positive screening for pain related to SCI diagnosis and/or
- positive screening for low mood and/or
Key exclusion criteria (2 listed)
- psychiatric condition that would interfere with participation
- major surgery in the next 8 months
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 |
|---|---|---|
| Collaborative CareAddition of a Health Care Assistant to treatment team, case review by expert panel of supervisors, non-medical interventions | Behavioural | Intervention |
Primary outcome
Change in Quality of Life
Time frame: Baseline, 4 months
Quality of Life is assessed via telephone interviews at baseline and 4 months.
5 secondary outcomes
Change in Pain
Time frame: Baseline, 4 months, 8 months
Change in Mood
Time frame: Baseline, 4 months, 8 months.
Change in Physical Activity
Time frame: Baseline, 4 months, 8 months
Change in Quality of Life
Time frame: Baseline, 8 months
Adverse events
Time frame: baseline to 4 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 26 Feb 2019.
- General study information on the Northwest Regional SCI System websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Charles H Bombardier, Ph.D. principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Care in people with Spinal Cord Injury, run by University of Washington.
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 7 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Change in Quality of Life (time frame: Baseline, 4 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 26 Feb 2019.