Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-22 @ 3:57 PM
Study NCT ID:
NCT01427660
Status:
COMPLETED
Last Update Posted:
2014-09-09
First Post:
2011-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iDecide.Decido: Diabetes Medication Decision Support Study
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-08', 'studyFirstSubmitDate': '2011-08-31', 'studyFirstSubmitQcDate': '2011-08-31', 'lastUpdatePostDateStruct': {'date': '2014-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in decisional conflict', 'timeFrame': 'baseline and 3 month post intervention', 'description': "We will be measuring subjects' perceptions of: a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice."}], 'secondaryOutcomes': [{'measure': 'Medication adherence and intensification', 'timeFrame': 'baseline and 3 month post intervention', 'description': 'Self-reported medication adherence will be assessed through three well-validated measures. We will assess changes in anti-hyperglycemic medication dosages and/or numbers of medications by patient report and medical record review.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Decision Aid', 'AntiHyperglycemic Medication', 'Tailored health information', 'Medication information'], 'conditions': ['Diabetes, Type 2']}, 'referencesModule': {'references': [{'pmid': '25402398', 'type': 'DERIVED', 'citation': 'Heisler M, Choi H, Palmisano G, Mase R, Richardson C, Fagerlin A, Montori VM, Spencer M, An LC. Comparison of community health worker-led diabetes medication decision-making support for low-income Latino and African American adults with diabetes using e-health tools versus print materials: a randomized, controlled trial. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S13-22. doi: 10.7326/M13-3012.'}]}, 'descriptionModule': {'briefSummary': 'Two of AHRQ \'s consumer-focused guides, "Pills for Type 2 Diabetes" and "Premixed Insulin for Type 2 Diabetes" could be of great use to underserved ethnic and racial minority adults. The presentation of content and delivery mechanisms of these Guides, however, needs to be modified to increase their use and impact among these difficult-to-reach populations.\n\nTo achieve this goal, a long-standing collaboration among African American and Latino community organizations, health care centers and systems, public health organizations, and academics (the REACH Detroit Partnership) is joining with leading experts in the development of personally and culturally tailored health decision aids (University of Michigan\'s Center for Health Communications Research \\[CHCR\\] and Center for Behavioral and Decision Sciences in Medicine \\[CBDSM\\]).\n\nThe investigators will develop and evaluate a computer tailored online diabetes medication decision aid that will enable community health workers (CHWs) to provide personalized patient education materials to underserved diabetic African American and Latino adults in Detroit, Michigan.', 'detailedDescription': "The Specific Aims of this study are:\n\nAim 1: To use the information in the two diabetes medications consumer CERSGs to build an interactive, computer tailored diabetes medication guide that will enable patients to assess their treatment goals, personal preferences, and side-effect concerns and generate a personally tailored assessment of their current diabetes treatments with, as appropriate, options for improving their diabetes care;\n\nAim 2: To determine the extent to which this personally tailored diabetes medication guide compared with the print consumer guides reduces Latino and African American diabetes patients' decisional conflict, through improved knowledge of anti-hyperglycemic medications and satisfaction with information received.\n\nAim 3: To examine the computer tailored program's effects on participants' changes in medications (medication intensification), self-reported medication adherence and beliefs and A1C levels between baseline and follow-up compared to participants receiving the print consumer guides."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes\n* stated concern about diabetes and diabetes treatment\n* poor glycemic control\n* over 21 years of age\n\nExclusion Criteria:\n\n* blind, deaf, otherwise unable to use the telephone or visual resources\n* pregnant\n* currently enrolled in other REACH Detroit research study\n* in hospice care\n* current radiation or chemotherapy'}, 'identificationModule': {'nctId': 'NCT01427660', 'acronym': 'iDecide', 'briefTitle': 'iDecide.Decido: Diabetes Medication Decision Support Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Technologically Enhanced Community Health Worker (CHW) Delivery of Personalized Diabetes Information', 'orgStudyIdInfo': {'id': '1R18HS019256-01', 'link': 'https://reporter.nih.gov/quickSearch/1R18HS019256-01', 'type': 'AHRQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional CERSG Arm', 'description': 'CHWs will provide and review with patients language-appropriate versions of the AHRQ consumer guides. CHWs will highlight key points on each page, review information on each medication and elicit and address questions. They will use the autonomy enhancing, motivational-interviewing based skills. As with the first arm, CHWs will schedule follow-up clinic appointments for participants who note a specific treatment change they would consider and will call participants two times after the session at three and six weeks to address additional questions and to follow up on any goals the participant set.', 'interventionNames': ['Behavioral: Community Health Worker Diabetes Education: Print media']}, {'type': 'EXPERIMENTAL', 'label': 'Web-Based Materials Arm', 'description': 'Participants randomized to this arm will be scheduled within 3 weeks of enrollment to have a one-hour face-to-face session with a CHW who will deliver the ipad platform personally tailored diabetes medication decision aid. Participants will receive a printed tailored preference summary at the completion of this visit. If participants note a specific treatment change they would like to discuss with their providers, the CHW will facilitate scheduling a clinic visit within the next month. Finally, CHWs will call participants two times after the session at 3 and 6 weeks to assess if the participant has additional questions and to follow up on any treatment or other goals the participant set during their session.', 'interventionNames': ['Behavioral: CHW Diabetes Education: tailored web site']}], 'interventions': [{'name': 'Community Health Worker Diabetes Education: Print media', 'type': 'BEHAVIORAL', 'otherNames': ['Print Materials Arm'], 'description': "Providing information to patients about potential benefits, harms, costs, and burdens of medications and discussing patients' treatment preferences.", 'armGroupLabels': ['Traditional CERSG Arm']}, {'name': 'CHW Diabetes Education: tailored web site', 'type': 'BEHAVIORAL', 'otherNames': ['Tailored web based decision aid'], 'description': "Providing tailored and interactive information to patients about potential benefits, harms, costs, and burdens of medications and discussing patients' treatment preferences.", 'armGroupLabels': ['Web-Based Materials Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48209', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Community Health and Social Service (CHASS)', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Michele Heisler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan Meidcal School; Ann Arbor VA Center for Clinical Management Research,'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project Manager', 'investigatorFullName': 'Rebecca Mase', 'investigatorAffiliation': 'University of Michigan'}}}}