Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-04-08 @ 1:25 PM
Study NCT ID:
NCT01561105
Status:
COMPLETED
Last Update Posted:
2012-03-28
First Post:
2012-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Depression Care for Elders: Coordinating Center
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D019263', 'term': 'Dysthymic Disorder'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1801}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-26', 'studyFirstSubmitDate': '2012-03-20', 'studyFirstSubmitQcDate': '2012-03-20', 'lastUpdatePostDateStruct': {'date': '2012-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of depression symptoms', 'description': 'Severity measured by the 21-item Hopkins Symptom Checklist.'}], 'secondaryOutcomes': [{'measure': 'Functioning', 'description': 'measured by the Sheehan Health-Related Functioning Index'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Major Depression', 'Dysthymic Disorder', 'Both Major Depression and Dysthymic Disorder']}, 'referencesModule': {'references': [{'pmid': '12472325', 'type': 'RESULT', 'citation': 'Unutzer J, Katon W, Callahan CM, Williams JW Jr, Hunkeler E, Harpole L, Hoffing M, Della Penna RD, Noel PH, Lin EH, Arean PA, Hegel MT, Tang L, Belin TR, Oishi S, Langston C; IMPACT Investigators. Improving Mood-Promoting Access to Collaborative Treatment. Collaborative care management of late-life depression in the primary care setting: a randomized controlled trial. JAMA. 2002 Dec 11;288(22):2836-45. doi: 10.1001/jama.288.22.2836.'}, {'pmid': '24367124', 'type': 'DERIVED', 'citation': 'Stewart JC, Perkins AJ, Callahan CM. Effect of collaborative care for depression on risk of cardiovascular events: data from the IMPACT randomized controlled trial. Psychosom Med. 2014 Jan;76(1):29-37. doi: 10.1097/PSY.0000000000000022. Epub 2013 Dec 23.'}]}, 'descriptionModule': {'briefSummary': 'Purpose: To determine the effectiveness of the Improving Mood-Promoting Access to Collaborative Treatment(IMPACT) collaborative care management program for late-life depression.', 'detailedDescription': "This study tested an organized method of delivering care for late life depression in primary care. Specifically, the investigators evaluated the effectiveness of this intervention as compared to 'care as usual'. The investigators studied the effect of the intervention on clinical outcomes such as depressive symptoms, functional status, health related quality of life. They also determined the cost-effectiveness of the intervention compared to care as usual."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major depression or dysthymia as diagnosed by a structured diagnostic interview.\n* Patient plans to receive primary care at the study clinic for the next year.\n\nExclusion Criteria:\n\n* Age under 60.\n* Current symptoms or history of psychosis or mania as determined by structured diagnostic interview.\n* Cognitive impairment as defined by a score less than 23 on a Mini Mental Status Examination.\n* Terminal illness - defined as having a life expectancy of less than 6 months.\n* Active alcohol abuse as determined by a screening interview.\n* High suicide risk as determined by current plan for suicide or a history of more than 3 prior suicide attempts in the past 10 years.'}, 'identificationModule': {'nctId': 'NCT01561105', 'acronym': 'IMPACT', 'briefTitle': 'Improving Depression Care for Elders: Coordinating Center', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'This Was a Five-year Seven-site Trial to Study the Cost-effectiveness of a Population Based Disease Management Program for Late Life Depression in Primary Care.', 'orgStudyIdInfo': {'id': 'JAHF 98297'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMPACT', 'interventionNames': ['Other: IMPACT']}, {'type': 'NO_INTERVENTION', 'label': 'Care as Usual', 'description': 'Patients received all depression care available to them as part of care as usual in the participating primary care clinics.'}], 'interventions': [{'name': 'IMPACT', 'type': 'OTHER', 'otherNames': ['Improving Mood-Promoting Access to Collaborative Treatment'], 'description': 'IMPACT is a collaborative care management program for late-life depression', 'armGroupLabels': ['IMPACT']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jurgen Unutzer, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'The John A. Hartford Foundation', 'class': 'OTHER'}, {'name': 'California HealthCare Foundation', 'class': 'OTHER'}, {'name': 'Hogg Foundation', 'class': 'UNKNOWN'}, {'name': 'Robert Wood Johnson Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Vice-Chair of Psychiatry, Psychiatry and Behavioral Sciences', 'investigatorFullName': 'Jurgen Unutzer, MD, MPH', 'investigatorAffiliation': 'University of Washington'}}}}