Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 8:13 PM
Study NCT ID:
NCT01943357
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2013-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Self Management Skills of Older Adults With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2013-09-09', 'studyFirstSubmitQcDate': '2013-09-11', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic control HbA1C', 'timeFrame': 'Baseline to 12 months'}], 'secondaryOutcomes': [{'measure': 'Symptom:fatigue', 'timeFrame': 'Baseline to 12 months', 'description': 'Single item visual numeric scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if change significant.'}, {'measure': 'symptom: sleep', 'timeFrame': 'Baseline to 12 months', 'description': 'Single item visual numeric scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if change significant.'}, {'measure': 'symptom: PHQ-8 depression', 'timeFrame': 'Baseline to 12 months', 'description': '8-item scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant.'}, {'measure': 'symptoms: hypoglycemic index', 'timeFrame': 'Baseline to 12 months', 'description': '7-item scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant.'}, {'measure': 'health behavior: blood glucose monitoring', 'timeFrame': 'Baseline to 12 months', 'description': 'Self report of how often monitor glucose at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant.'}, {'measure': 'health behavior: medication adherence', 'timeFrame': 'baseline to 12 months', 'description': '3-item scale collected at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant.'}, {'measure': 'Health behavior: communication with physician', 'timeFrame': 'baseline to 12 months', 'description': '3-item scale collected at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant.'}, {'measure': 'health behavior: exercise', 'timeFrame': 'baseline to 12 months', 'description': 'Minutes of exercise during last week self-reported at baseline, 6-months and 12-months. Paired t-tests used to assess if any changes are significant.'}, {'measure': 'health behavior/utilization: frequency of exams', 'timeFrame': 'baseline to 12 months', 'description': 'Self report of how often examine feet and have eye, cholesterol and kidney levels tested. Collected at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant.'}, {'measure': 'Health care utilization', 'timeFrame': 'baseline to 12 months', 'description': 'Physician, ED, hospital visits in last six-months. Self reported at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'patient education', 'self management', 'health improvement'], 'conditions': ['Type 2 Diabetes', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'The study will help determine if the Better Choices Better Health Diabetes program (community-based or online, also known as the Diabetes Self-Management Program) improves the hbA1C of people with Type-II diabetes. The investigators will also examine 1) symptoms (fatigue, sleep, low blood sugar symptoms, depression, shortness of breath), 2) healthy behaviors (blood sugar monitoring; taking medications as prescribed; getting eye, foot, kidney and cholesterol exams; and activity), 3) the use of health care services. This project is a translational study to demonstrate the effectiveness of the intervention in the context of a major insurer.', 'detailedDescription': 'Self-report questionnaires and hbA1c capillary blood collection kits will be administered at baseline (prior to the intervention), six-months and twelve-months. Differences between baseline and followup scores will be used to determine if participants have benefited from the intervention, using intent-to-treat methodology. Subgroups and delivery method (small-group or on-line) will be compared using repeated measures and analyses of covariance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes\n* WellPoint insurance or medicare supplement plan participant\n* 18 years or older\n\nExclusion Criteria:\n\n* Treatment for cancer in past year\n* Pregnant\n* Under 18\n* Previously taken a Stanford self-management program'}, 'identificationModule': {'nctId': 'NCT01943357', 'briefTitle': 'Improving Self Management Skills of Older Adults With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Improving the Self Management Skills of Older Adults With Diabetes', 'orgStudyIdInfo': {'id': '26679'}, 'secondaryIdInfos': [{'id': '109554', 'type': 'OTHER_GRANT', 'domain': 'NCOA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetes Self-Management Program', 'description': 'Behavioral: Diabetes Self Management Program. Consists of either a six-week small-group face-to-face program with two peer leaders or an six-week peer-facilitated Internet-based program.', 'interventionNames': ['Behavioral: Diabetes Self Management Program']}], 'interventions': [{'name': 'Diabetes Self Management Program', 'type': 'BEHAVIORAL', 'otherNames': ['Better Choices Better Health--Diabetes'], 'description': 'The interventions include modeling and action-planning to enhance self-efficacy.', 'armGroupLabels': ['Diabetes Self-Management Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94306', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Kate Lorig, DPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'HealthCore, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor emertius', 'investigatorFullName': 'Kate Lorig', 'investigatorAffiliation': 'Stanford University'}}}}