Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-01 @ 12:06 PM
Study NCT ID:
NCT04385758
Status:
COMPLETED
Last Update Posted:
2022-10-07
First Post:
2020-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Paramedicine Program to Improve Diabetes Care Quality, Equity, and Outcomes
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-06', 'studyFirstSubmitDate': '2020-05-07', 'studyFirstSubmitQcDate': '2020-05-09', 'lastUpdatePostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetes Distress (using DDS)', 'timeFrame': '1 month', 'description': 'The level of diabetes-related distress that is expressed by patient participants using the Diabetes Distress Scale (the DDS contains 17 questions, with responses ranging from "Not a Problem" (1) to "A Very Serious Problem" (6). Total scores use the sum of all responses divided by 17, with a mean item score of 3 or higher (moderate distress) indicating distress worthy of clinical attention.)'}], 'secondaryOutcomes': [{'measure': 'Diabetes Distress (using DDS)', 'timeFrame': '4 months', 'description': 'The level of diabetes-related distress that is expressed by patient participants using the Diabetes Distress Scale (the DDS contains 17 questions, with responses ranging from "Not a Problem" (1) to "A Very Serious Problem" (6). Total scores use the sum of all responses divided by 17, with a mean item score of 3 or higher (moderate distress) indicating distress worthy of clinical attention.)'}, {'measure': 'Confidence in Diabetes Self-Management (using DSMQ)', 'timeFrame': '1 and 4 months', 'description': 'The level of confidence patient participants express in managing their diabetes using the Diabetes Self-Management Questionnaire (DSMQ)'}, {'measure': 'Health-Related Quality of Life (using EQ-5D)', 'timeFrame': '1 and 4 months', 'description': "Patients participants' self-reported health-related quality of life using the EuroQol 5-D (also known as EQ-5D; an instrument for measuring quality of life)"}, {'measure': 'Self-Reported Hypoglycemia and Hyperglycemia', 'timeFrame': '1 and 4 months', 'description': 'Incidences of hypoglycemia (blood glucose \\<70 mg/dL and \\<54 mg/dL) and hyperglycemia (blood glucose ≥250 mg/dL) as reported by patient participants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Community paramedicine', 'Diabetes mellitus', 'Diabetes distress'], 'conditions': ['Diabetes', 'Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '35450906', 'type': 'DERIVED', 'citation': 'Juntunen MB, Liedl CP, Carlson PN, Myers LA, Stickler ZR, Ryan Schultz JA, Meilander AK, Behnken E, Lampman MA, Rogerson MC, Fischer KM, McCoy RG. Diabetes Rescue, Engagement and Management (D-REM): rationale and design of a pragmatic clinical trial of a community paramedicine programme to improve diabetes care. BMJ Open. 2022 Apr 21;12(4):e057224. doi: 10.1136/bmjopen-2021-057224.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is evaluate the effectiveness of Diabetes-REM (Rescue, Engagement, and Management), a comprehensive community paramedic (CP) program to support adults in Southeast Minnesota (Mower, Freeborn, and Olmsted counties) and Northwest Wisconsin (Barron, Rusk, and Dunn) who have uncontrolled diabetes (HbA1c ≥ 9%) and have experienced an emergency department (ED) visit or hospitalization for any cause in the prior 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (Patients):\n\n* Most recent hemoglobin A1c ≥ 9% within the last 2 years.\n* Age ≥ 18 years old.\n* Type 1 or type 2 diabetes.\n* Paneled to a Mayo Clinic or Mayo Clinic Health System practice.\n* Able to provide informed consent.\n* Proficient in English.\n* Community-dwelling.\n* Live in Southeast Minnesota (Mower, Freeborn, or Olmsted counties) or Northwest Wisconsin (Barron, Rusk, or Dunn counties).\n\nInclusion Criteria (Paramedics):\n\n•Community Paramedics who delivered the Diabetes-REM intervention.\n\nExclusion Criteria:\n\n* Cognitive impairment precluding informed consent.\n* Lack of conversational English skills.\n* Resident of a long-term care facility.\n* Enrolled in hospice.\n* Enrolled in a care coordination or disease management program.\n* Advanced or terminal illness.'}, 'identificationModule': {'nctId': 'NCT04385758', 'briefTitle': 'Community Paramedicine Program to Improve Diabetes Care Quality, Equity, and Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Community Paramedicine Program to Improve Diabetes Care Quality, Equity, and Outcomes', 'orgStudyIdInfo': {'id': '20-001011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetes-REM Program', 'interventionNames': ['Other: Diabetes-REM Program']}], 'interventions': [{'name': 'Diabetes-REM Program', 'type': 'OTHER', 'description': 'A comprehensive community paramedicine management program designed to support adults with uncontrolled diabetes and a recent emergency department visit or hospitalization', 'armGroupLabels': ['Diabetes-REM Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Rozalina McCoy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rozalina G. McCoy', 'investigatorAffiliation': 'Mayo Clinic'}}}}