Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT05789706
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2022-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of a Smart-phone Based Medication Adherence Platform to Improve Outcomes in Uncontrolled Non-insulin Dependent Diabetes Among Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This study will employ a case-crossover design where patients will undergo both a standard of care arm as well as an intervention arm. Half of the study participants will be randomized and enrolled in the standard of care arm for the initial 3 months and then transition to the intervention arm for 3 months. The remaining patients will be enrolled in the intervention arm for the initial 3 months and then transitioned to the standard of care arm.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2022-10-24', 'studyFirstSubmitQcDate': '2023-03-15', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from pre-intervention baseline in hemoblobin A1c', 'timeFrame': '3 months', 'description': 'The change from pre-intervention baseline in hemoblobin A1c (HgA1c) to 3 months in the intervention arm compared to change from baseline to 3 months in the standard of care arm'}], 'secondaryOutcomes': [{'measure': 'Change in Medication Adherence Score from baseline', 'timeFrame': '3 months', 'description': 'change from baseline to 3 months in medication adherence score in the intervention arm compared to change from baseline to 3 months in medication adherence score in the standard of care arm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabete Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a novel smartphone-based medication adherence platform accompanied by directed pharmacist intervention can improve A1c control and medication compliance in non-insulin dependent diabetics.', 'detailedDescription': "This study will employ a case-crossover design where patients will undergo both a standard of care arm as well as an intervention arm (See Figure 1). Half of the study participants will be randomized and enrolled in the standard of care arm for the initial 3 months and then transition to the intervention arm for 3 months. The remaining patients will be enrolled in the intervention arm for the initial 3 months and then transitioned to the standard of care arm.\n\nPrimary outcomes will be the change from pre-intervention baseline in hemoblobin A1c (HgA1c) between the Dayamed Arthur platform and standard of care.\n\nSecondary outcomes will include change in MAS, the change in RMA from week 1 of intervention arm to week 12, comparison of historical MPR and PDC with patient's RMA at week 1 of intervention arm, and correlation of change in RMA and MAS score during intervention arm. Furthermore, we will measure sustained change in MAS in the patient population who begin study in the intervention arm and are subsequently transitioned to standard of care. We will also collect information patient usability/acceptability and provider satisfaction with the Dayamed Arthur platform.\n\nExploratory outcomes will include potential reduction in healthcare resource utilization based on avoidance of therapy escalation in patients with improved compliance, as well as psychosocial factors associated with improved adherence\n\nReduction of HgbA1c by 0.5% from pre-intervention baseline for individuals on the DayaMed intervention compared to standard of care"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Assigned primary care provider at VA Sierra Nevada Healthcare System (VASNHCS)\n* Diagnosis of type 2 diabetes\n* Own a smart phone/tablet\n* HgbA1c drawn at or within 30 days of study enrollment.\n* Uncontrolled A1c defined as an A1c \\>9 in the following order of preference\n\n * Last 3 A1cs \\>9% in the last 2 year\n * Last 2 A1cs \\>9% in the last 2 years\n * Last A1c \\>9% in the last 2 years\n * 2-year average A1c \\>9%\n\nExclusion Criteria:\n\n* Actively on insulin therapy\n* Unable to install DayaMed application onto their phone/tablet\n* Unable to load medications'}, 'identificationModule': {'nctId': 'NCT05789706', 'briefTitle': 'Use of a Smart-phone Based Medication Adherence Platform to Improve Outcomes in Uncontrolled Non-insulin Dependent Diabetes Among Veterans', 'organization': {'class': 'FED', 'fullName': 'VA Sierra Nevada Health Care System'}, 'officialTitle': 'Use of a Smart-phone Based Medication Adherence Platform to Improve Outcomes in Uncontrolled Non-insulin Dependent Diabetes Among Veterans: a Pragmatic, Point-of-care, Implementation Effectiveness Pilot Study', 'orgStudyIdInfo': {'id': '1655381'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Patients will have Dayamed Arthur a novel intelligent medication adherence platform installed on their smartphone and configured with their pharmacy data providing accurate prompts and reminders to patients to take medications as directed In addition to the prompts patient all auditable information will be relayed to their PACT CPS through a provider dashboard allowing for timely and directed clinical intervention. Dayamed Arthur will provide automated alerts to the patients care team in specific scenarios.', 'interventionNames': ['Behavioral: Dayamed Arthur a novel intelligent medication adherence platform']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care Arm', 'description': 'Study subjects will be counseled on medication adherence and strategies to remember how to take their medications correctly. Study subjects will then be followed as clinically indicated by their clinical care team.'}], 'interventions': [{'name': 'Dayamed Arthur a novel intelligent medication adherence platform', 'type': 'BEHAVIORAL', 'description': 'Novel smart phone adherence application configured with subject pharmacy data providing accurate reminders of when to take medications and providing auditable user feed back to clinical care teams for patient response directed provider intervention.', 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'VA Sierra Nevada Health Care System', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Sierra Nevada Health Care System', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Chief of Pharmacy - Health Outcomes and Analytics', 'investigatorFullName': 'Amneet Rai', 'investigatorAffiliation': 'VA Sierra Nevada Health Care System'}}}}