Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-02-17 @ 6:50 PM
Study NCT ID:
NCT00542204
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2007-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Online Personalized Health Record System to Promote Self-Management of Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 415}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2007-10-09', 'studyFirstSubmitQcDate': '2007-10-09', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1C', 'timeFrame': 'Baseline, 6 months and 12 months'}], 'secondaryOutcomes': [{'measure': 'Self-management practices(e.g., medication adherence, home monitoring of glucose and BP, diet, and exercise)', 'timeFrame': 'Baseline, 6 months and 12 months'}, {'measure': 'Processes of care (e.g., frequency of lab testing)', 'timeFrame': 'Baseline, 6 months and 12 months'}, {'measure': 'Cardiovascular risk (e.g., blood pressure and lipids)', 'timeFrame': 'Baseline, 6 months and 12 months'}, {'measure': 'Patient experience and satisfaction (e.g., relevant CAHPS measures)', 'timeFrame': 'Baseline and 12 months'}, {'measure': 'Patient psychosocial well-being (e.g., diabetes-related emotional distress)', 'timeFrame': 'Baseline, 6 months and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'Blood Glucose Self-Monitoring', 'Home Blood Glucose Monitoring', 'Internet', 'Personal Health Record (PHR)', 'Health Information Technology (HIT)', 'Care management', 'Disease Management', 'Diabetes self-management', 'Consumer Health Information', 'Medical Records Systems, Computerized', 'Computerized Medical Records System', 'Automated Medical Records System', 'Electronic Health Record (EHR)', 'Remote patient monitoring'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '23171659', 'type': 'DERIVED', 'citation': 'Tang PC, Overhage JM, Chan AS, Brown NL, Aghighi B, Entwistle MP, Hui SL, Hyde SM, Klieman LH, Mitchell CJ, Perkins AJ, Qureshi LS, Waltimyer TA, Winters LJ, Young CY. Online disease management of diabetes: engaging and motivating patients online with enhanced resources-diabetes (EMPOWER-D), a randomized controlled trial. J Am Med Inform Assoc. 2013 May 1;20(3):526-34. doi: 10.1136/amiajnl-2012-001263. Epub 2012 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'Diabetes is a major, growing, and costly chronic disease in the U.S., and implementation of recommended diabetes care remains poor, not merely suboptimal, and varied for a sizable proportion of Americans with diabetes. To further reduce the treatment and adherence gaps in diabetes care, the researchers propose to evaluate a Customized, Continuous Care Management (CCCM) program that actively supports a partnership between the patient and his/her multidisciplinary care management (CM) team using an online disease management (ODM) system, which is integrated with a comprehensive electronic health record (EHR) system that includes a personal health record and secure patient-clinician messaging capabilities. The CCCM program builds upon CM strategies proven effective in past studies and creates an ODM system that is built upon and fully integrated with a leading, commercially available EHR product - providing a blueprint for instituting customized, continuous care management for many different chronic conditions in a range of ambulatory care settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>= 18 years of age\n* Have a designated Palo Alto Medical Foundation Primary Care Provider (PCP)\n* Seen in primary or specialty care at the Palo Alto Division at least once in the preceding 24 months\n* Diagnosis of diabetes\n* Baseline A1C \\>= 7.5%\n\nExclusion Criteria:\n\n* Initial diagnosis of diabetes within the last 12 months\n* Diagnosis of Type 1 diabetes\n* Inability to speak and read in English\n* Lack of regular access to a computer with Internet and email capabilities\n* Unwilling to perform any self-monitoring at home, including blood glucose and blood pressure%\n* Pregnant, planning to become pregnant, or lactating\n* Currently enrolled in a care management program at Palo Alto Medical Foundation or elsewhere\n* PCP determination that the study is inappropriate or unsafe for the patient\n* Investigator discretion for clinical safety or protocol adherence reasons'}, 'identificationModule': {'nctId': 'NCT00542204', 'acronym': 'EMPOWER-D', 'briefTitle': 'Use of Online Personalized Health Record System to Promote Self-Management of Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Palo Alto Medical Foundation'}, 'officialTitle': 'Patient-Centered Online Disease Management Using a Personal Health Record System', 'orgStudyIdInfo': {'id': '1R18HS017179-01', 'link': 'https://reporter.nih.gov/quickSearch/1R18HS017179-01', 'type': 'AHRQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Online disease management', 'description': 'The PAMFOnline-mediated Personalized Health Care Program, which couples a multidisciplinary diabetes care management team with an EHR-integrated Online Disease Management (ODM) system.', 'interventionNames': ['Behavioral: Online disease management']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual medical care. No access to the PHCP electronic system and self-management tools supporting this care management.'}], 'interventions': [{'name': 'Online disease management', 'type': 'BEHAVIORAL', 'otherNames': ['EMPOWER-D'], 'description': 'The Personalized Health Care Program couples a multidisciplinary care management team with an EHR-integrated Online Disease Management (ODM) system.', 'armGroupLabels': ['Online disease management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'PAMF Palo Alto Health Care Division', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '94022', 'city': 'Los Altos', 'state': 'California', 'country': 'United States', 'facility': 'PAMF Palo Alto Health Care Division', 'geoPoint': {'lat': 37.38522, 'lon': -122.11413}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'PAMF Camino Region', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'PAMF Palo Alto Health Care Division', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'PAMF Palo Alto Health Care Division', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '95062', 'city': 'Santa Cruz', 'state': 'California', 'country': 'United States', 'facility': 'PAMF Santa Cruz Medical Clinic', 'geoPoint': {'lat': 36.97412, 'lon': -122.0308}}], 'overallOfficials': [{'name': 'Paul Tang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Palo Alto Medical Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Palo Alto Medical Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}, {'name': 'Sutter Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President', 'investigatorFullName': 'Paul Tang', 'investigatorAffiliation': 'Palo Alto Medical Foundation'}}}}