Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-03 @ 11:28 AM
Study NCT ID:
NCT02026167
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2013-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Cord Injury Collaborative Care Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-23', 'studyFirstSubmitDate': '2013-12-26', 'studyFirstSubmitQcDate': '2013-12-30', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline, 4 months', 'description': 'Quality of Life is assessed via telephone interviews at baseline and 4 months.'}], 'secondaryOutcomes': [{'measure': 'Change in Pain', 'timeFrame': 'Baseline, 4 months, 8 months', 'description': 'Pain is assessed via telephone interview at baseline, 4 months, and 8 months.'}, {'measure': 'Change in Mood', 'timeFrame': 'Baseline, 4 months, 8 months.', 'description': 'Mood assessed via telephone interviews at baseline, 4 months, and 8 months.'}, {'measure': 'Change in Physical Activity', 'timeFrame': 'Baseline, 4 months, 8 months', 'description': 'Physical activity is assess via telephone interview at baseline, 4 months, and 8 months.'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline, 8 months', 'description': 'Change in QOL from baseline to 8 months will be compared between groups'}, {'measure': 'Adverse events', 'timeFrame': 'baseline to 4 months', 'description': 'The number of cases with serious or non-serious adverse events in the two arms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Pain', 'Mood', 'Physical Activity'], 'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://sci.washington.edu/scicare/', 'label': 'General study information on the Northwest Regional SCI System website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years of age or older\n* diagnosis of traumatic spinal cord injury by medical record review\n* receives primary SCI care from a provider at the University of Washington or Harborview Medical Center's Rehabilitation Outpatient Clinic\n* positive screening for pain related to SCI diagnosis and/or\n* positive screening for low mood and/or\n* negative screening for physical activity levels\n* able to speak and understand English\n\nExclusion Criteria:\n\n* psychiatric condition that would interfere with participation\n* major surgery in the next 8 months"}, 'identificationModule': {'nctId': 'NCT02026167', 'acronym': 'SCI-Care', 'briefTitle': 'Spinal Cord Injury Collaborative Care Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'SCI-CARE (Northwest Regional Spinal Cord Injury Site Specific Project)', 'orgStudyIdInfo': {'id': 'STUDY00001791'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'No intervention, usual care'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Collaborative care with Health Care Assistant', 'interventionNames': ['Behavioral: Collaborative Care']}], 'interventions': [{'name': 'Collaborative Care', 'type': 'BEHAVIORAL', 'description': 'Addition of a Health Care Assistant to treatment team, case review by expert panel of supervisors, non-medical interventions', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Charles H Bombardier, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Department of Education', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Rehabilitation Medicine', 'investigatorFullName': 'Charles Bombardier', 'investigatorAffiliation': 'University of Washington'}}}}