Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-29 @ 9:14 PM
Study NCT ID:
NCT02122250
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2013-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Web-based Support for People With Type 2 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1041}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-02', 'studyFirstSubmitDate': '2013-03-21', 'studyFirstSubmitQcDate': '2014-04-23', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Single item: whether you would recommend the website to others', 'timeFrame': 'Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.'}], 'primaryOutcomes': [{'measure': 'user engagement', 'timeFrame': 'This will be measured by intervention completion rates'}], 'secondaryOutcomes': [{'measure': 'Patient enablement', 'timeFrame': 'Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.'}, {'measure': 'Website satisfaction', 'timeFrame': 'Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.'}, {'measure': 'Physical activity attitudes and intentions', 'timeFrame': 'Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.'}, {'measure': 'Diabetes and Physical activity knowledge', 'timeFrame': 'Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.'}]}, 'conditionsModule': {'keywords': ['Diabetes', 'Health literacy', 'web intervention'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': "This project will address vital questions regarding how best to design web-based materials for the growing population of patients with basic literacy and computer skills but lower levels of health literacy, building on our previous experience of developing web-based materials for people with lower levels of literacy and health literacy.\n\nThis study will be carried out two phases. Phase 1 will use qualitative methods to understand user experiences of the web-based materials through observational 'think-aloud' interviews with users. Phase 2 will test the newly developed web-based materials to a static (non-interactive) version of the materials online."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Potential participants are patients with Type 2 diabetes aged 18 years or more, who are able to consent.\n\nExclusion Criteria:\n\n* Severe mental health problems, palliative care, recent bereavement, known opposition to involvement in research or inability to complete research measures, e.g. learning disability, inability to read / speak English.'}, 'identificationModule': {'nctId': 'NCT02122250', 'briefTitle': 'Web-based Support for People With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Southampton'}, 'officialTitle': 'Developing and Testing Accessible Web-based Support for Patient Self-management of Diabetes', 'orgStudyIdInfo': {'id': '4746'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interactive web-based materials', 'description': 'Interactive web-based materials for self-management of diabetes', 'interventionNames': ['Behavioral: Interactive web-based materials']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Static web-based materials', 'description': 'Static version of the interactive web-based materials', 'interventionNames': ['Behavioral: Static web-based materials']}], 'interventions': [{'name': 'Interactive web-based materials', 'type': 'BEHAVIORAL', 'description': 'Interactive web-based materials for self-management of diabetes', 'armGroupLabels': ['Interactive web-based materials']}, {'name': 'Static web-based materials', 'type': 'BEHAVIORAL', 'description': 'Static web-based materials', 'armGroupLabels': ['Static web-based materials']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lucy Yardley', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southampton'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southampton', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}