Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT00877851
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2009-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of a Computer-Based, Self-Management Tool for People With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'm.mckinley@qub.ac.uk', 'phone': '+44(0)2890632685', 'title': 'Prof Michelle McKinley', 'organization': "Queen's University, Belfast"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1 Computer-based Program', 'description': 'Use of Computer-based Program for 12 weeks\n\nComputer-based Program: The intervention group will receive an initial training session which will include a demonstration of the layout and main features of the computer-based program and some instructions on how to navigate around the different sections of the program. As a minimum level of use, participants will be asked to use the self-monitoring and goal setting aspects of the computer-based program on at least a weekly basis.', 'otherNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 Control', 'description': 'Usual care and list of useful websites', 'otherNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Between Group Differences in Diabetes Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Computer-based Program', 'description': 'Use of Computer-based Program for 12 weeks\n\nComputer-based Program: The intervention group will receive an initial training session which will include a demonstration of the layout and main features of the computer-based program and some instructions on how to navigate around the different sections of the program. As a minimum level of use, participants will be asked to use the self-monitoring and goal setting aspects of the computer-based program on at least a weekly basis.'}, {'id': 'OG001', 'title': '2 Control', 'description': 'Usual care and list of useful websites'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '64', 'spread': '14.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'ADKnowl questionnaire', 'unitOfMeasure': 'Percent of items correct', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Between Group Differences in Goal Setting', 'timeFrame': '12 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Between Group Differences in Dietary Intake', 'timeFrame': '12 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Between Group Differences in Physical Activity Levels', 'timeFrame': '12 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Between Group Difference in Anthropometry', 'timeFrame': '12 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Between Group Differences in Markers of Cardiovascular Risk', 'timeFrame': '12 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Between Group Differences in Markers of Blood Glucose Control', 'timeFrame': '12 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Between Group Differences in Self-Efficacy and Barriers to Management of Diabetes', 'timeFrame': '12 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 Computer-based Program', 'description': 'Use of Computer-based Program for 12 weeks\n\nComputer-based Program: The intervention group will receive an initial training session which will include a demonstration of the layout and main features of the computer-based program and some instructions on how to navigate around the different sections of the program. As a minimum level of use, participants will be asked to use the self-monitoring and goal setting aspects of the computer-based program on at least a weekly basis.'}, {'id': 'FG001', 'title': '2 Control', 'description': 'Usual care and list of useful websites'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'computer problem', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'no longer interested in participating', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1 Computer-based Program', 'description': 'Use of Computer-based Program for 12 weeks\n\nComputer-based Program: The intervention group will receive an initial training session which will include a demonstration of the layout and main features of the computer-based program and some instructions on how to navigate around the different sections of the program. As a minimum level of use, participants will be asked to use the self-monitoring and goal setting aspects of the computer-based program on at least a weekly basis.'}, {'id': 'BG001', 'title': '2 Control', 'description': 'Usual care and list of useful websites'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '60', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '59', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-06', 'studyFirstSubmitDate': '2009-04-07', 'resultsFirstSubmitDate': '2022-07-06', 'studyFirstSubmitQcDate': '2009-04-07', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-06', 'studyFirstPostDateStruct': {'date': '2009-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Between Group Differences in Diabetes Knowledge', 'timeFrame': '12 weeks', 'description': 'ADKnowl questionnaire'}, {'measure': 'Between Group Differences in Goal Setting', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Between Group Differences in Dietary Intake', 'timeFrame': '12 weeks'}, {'measure': 'Between Group Differences in Physical Activity Levels', 'timeFrame': '12 weeks'}, {'measure': 'Between Group Difference in Anthropometry', 'timeFrame': '12 weeks'}, {'measure': 'Between Group Differences in Markers of Cardiovascular Risk', 'timeFrame': '12 weeks'}, {'measure': 'Between Group Differences in Markers of Blood Glucose Control', 'timeFrame': '12 weeks'}, {'measure': 'Between Group Differences in Self-Efficacy and Barriers to Management of Diabetes', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diet', 'Physical activity', 'Self management', 'Goal setting'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '27446961', 'type': 'DERIVED', 'citation': 'Booth AO, Lowis C, Hunter SJ, Dean M, Cardwell CR, McKinley MC. Development and Evaluation of a Computer-Based, Self-Management Tool for People Recently Diagnosed with Type 2 Diabetes. J Diabetes Res. 2016;2016:3192673. doi: 10.1155/2016/3192673. Epub 2016 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'NEW Brief Summary: Managing diet and physical activity are vital aspects of diabetes self-care; however, people with diabetes often find it difficult to make changes to their usual diet and physical activity patterns. There is some evidence that computer based education may help some people develop the skills they need to better manage their diabetes. The investigators have developed an external hard drive (a USB stick), focusing on knowledge, self-monitoring, goal setting and skill-development in relation to diet and physical activity for people with Type 2 diabetes. A major emphasis was placed on eliciting the views of people with Type 2 diabetes throughout the development of the computer based program. This study will examine whether this computer based program can improve knowledge, skills and self-care behaviour in people with diabetes. One hundred participants who have been diagnosed with Type 2 diabetes in the past 2 years will be assigned by chance to one of two groups: they will either be assigned to continue with their normal care routine consulting with their doctor as normal, or they will be assigned to use the USB stick at least once a week for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical diagnosis of Type 2 diabetes in the past 2 years\n* Have access to a computer on a regular basis\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Other medical conditions where changes in diet or physical activity would be contraindicated'}, 'identificationModule': {'nctId': 'NCT00877851', 'acronym': 'LWD', 'briefTitle': 'Evaluation of a Computer-Based, Self-Management Tool for People With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': "Queen's University, Belfast"}, 'officialTitle': 'Development and Evaluation of a Computer-Based, Self-Management Tool for People Recently Diagnosed With Type 2 Diabetes (Evaluation Phase)', 'orgStudyIdInfo': {'id': '08/NIR01/97'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Computer-based Program', 'description': 'Use of Computer-based Program for 12 weeks', 'interventionNames': ['Behavioral: Computer-based Program']}, {'type': 'NO_INTERVENTION', 'label': '2 Control', 'description': 'Usual care and list of useful websites'}], 'interventions': [{'name': 'Computer-based Program', 'type': 'BEHAVIORAL', 'description': 'The intervention group will receive an initial training session which will include a demonstration of the layout and main features of the computer-based program and some instructions on how to navigate around the different sections of the program. As a minimum level of use, participants will be asked to use the self-monitoring and goal setting aspects of the computer-based program on at least a weekly basis.', 'armGroupLabels': ['1 Computer-based Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT12 6BJ', 'city': 'Belfast', 'state': 'Antrim', 'country': 'United Kingdom', 'facility': "Queen's University Belfast", 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'city': 'Belfast', 'state': 'Antrim', 'country': 'United Kingdom', 'facility': 'Belfast Health and Social Care Trust', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'overallOfficials': [{'name': 'Michelle McKinley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University, Belfast"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University, Belfast", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Michelle McKinley', 'investigatorFullName': 'Michelle McKinley', 'investigatorAffiliation': "Queen's University, Belfast"}}}}