Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-02-04 @ 8:09 AM
Study NCT ID:
NCT01845857
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2010-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A National Study of the Chronic Disease Self-Management Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-30', 'studyFirstSubmitDate': '2010-08-09', 'studyFirstSubmitQcDate': '2013-04-30', 'lastUpdatePostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Health Status (symptoms, activities limitations)', 'timeFrame': 'Baseline to 6 months'}, {'measure': 'Change in Health Status (symptoms, activities limitations)', 'timeFrame': 'baseline to 12 months'}], 'secondaryOutcomes': [{'measure': 'Change in Health behaviors (exercise, medical adherence)', 'timeFrame': 'baseline to 6 months'}, {'measure': 'Change in health related quality of life', 'timeFrame': 'baseline to 6 months'}, {'measure': 'Change in Metabolic control (HbA1c for type 2 diabetics)', 'timeFrame': 'baseline to 6 months'}, {'measure': 'Change in Health Care Utilization', 'timeFrame': 'baseline to 6 months', 'description': 'MD, emergency, hospital times and total nights'}, {'measure': 'Change in Health behaviors (exercise, medical adherence)', 'timeFrame': 'baseline to 12 months'}, {'measure': 'Change in health related quality of life', 'timeFrame': 'baseline to 12 months'}, {'measure': 'Change in Metabolic control (HbA1c for type 2 diabetics)', 'timeFrame': 'baseline to 12 months'}, {'measure': 'Change in Health Care Utilization', 'timeFrame': 'baseline to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Long term health problems', 'chronic disease'], 'conditions': ['Diabetes Mellitus, Type 2', 'Chronic Disease']}, 'referencesModule': {'references': [{'pmid': '11606875', 'type': 'BACKGROUND', 'citation': 'Lorig KR, Ritter P, Stewart AL, Sobel DS, Brown BW Jr, Bandura A, Gonzalez VM, Laurent DD, Holman HR. Chronic disease self-management program: 2-year health status and health care utilization outcomes. Med Care. 2001 Nov;39(11):1217-23. doi: 10.1097/00005650-200111000-00008.'}, {'pmid': '14639082', 'type': 'BACKGROUND', 'citation': 'Lorig KR, Ritter PL, Gonzalez VM. Hispanic chronic disease self-management: a randomized community-based outcome trial. Nurs Res. 2003 Nov-Dec;52(6):361-9. doi: 10.1097/00006199-200311000-00003.'}]}, 'descriptionModule': {'briefSummary': "This survey will address important research, practice, and policy questions: How does Chronic Disease Self-Management Program (CDSMP) impact participants' general health, their health behaviors, and their need for health care utilization? Who benefits most from the CDSMP program? Are predicted gains maintained over a six and twelve month period? Can critical clinical changes be seen for those who are diabetic?", 'detailedDescription': "A national survey of participant outcomes is important for documenting how the CDSMP program is impacting people with chronic diseases and influencing health care outcomes. This study will help bridge the research to practice gap and further our knowledge about the outcomes of evidence?based programs that are widely disseminated.\n\nInvestigators hope to learn the answers to the following questions for English and Spanish-speaking populations:\n\n1. How does the CDSMP impact a person's general health?\n2. Does the CDSMP increase the use of healthful behaviors?\n3. Does the CDSMP impact health care utilization?\n4. What are the characteristics of those who benefit from the CDSMP?\n5. Can these benefits be maintained over 6 and 12 month periods?\n6. For people with type 2 diabetes, and hemoglobin A1c be impacted by the CDSMP?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or over\n* Has a chronic health condition\n* Attending a Chronic Disease Self-Management Workshop at a designated host site in the United states\n* Speaks English or Spanish\n* For blood test portion of study: have type 2 diabetes\n\nExclusion Criteria:\n\n* Do not meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT01845857', 'briefTitle': 'A National Study of the Chronic Disease Self-Management Program', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A National Study of the Chronic Disease Self-Management Program', 'orgStudyIdInfo': {'id': 'SU-07212010-6585'}, 'secondaryIdInfos': [{'id': '18933 IRB Protocol'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chronic Disease Self-Management Workshop', 'description': 'Longitudinal study of participants who take the CDSMP workshop', 'interventionNames': ['Behavioral: Chronic Disease Self-Management Workshop']}], 'interventions': [{'name': 'Chronic Disease Self-Management Workshop', 'type': 'BEHAVIORAL', 'description': '6 week, small group self-management workshop', 'armGroupLabels': ['Chronic Disease Self-Management Workshop']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Kate R Lorig', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor emertius', 'investigatorFullName': 'Kate Lorig', 'investigatorAffiliation': 'Stanford University'}}}}