Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06901258
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-29
First Post:
2025-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genius PillBox Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of Pillbox', 'timeFrame': '1 Month', 'description': 'Acceptability Questionnaire, scores range from 9-36, higher scores indicate greater acceptability.'}, {'measure': 'Fidelity of Pillbox Use', 'timeFrame': '1 Month', 'description': 'Individual items to assess use of pillbox over 30-day period. 3 items will quantify the degree and extent which the participant used the pillbox over the past 30 day.'}], 'secondaryOutcomes': [{'measure': 'Medication Adherence', 'timeFrame': 'Baseline, 1 Month', 'description': 'Extent of Medication Nonadherence Scale. 3-item questionnaire, scores range from 1-5 (lower scores indicate better medication adherence)'}, {'measure': 'Medication Adherence', 'timeFrame': 'Baseline, 1 Month', 'description': 'Patient Medication Adherence Questionnaire. 3-item questionnaire, scores are summed (range 0-3), and scores of 1 or greater = non-adherence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Older Adults (65 Years and Older)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to pilot test the how acceptable older adults find a commercially available pillbox organizer with embedded sensors and automated reminders to support medication adherence.', 'detailedDescription': 'The purpose of this study is to pilot test how acceptable older adults find a commercially available pillbox organizer with embedded sensors and automated reminders to support medication adherence. Individuals who agree to participate in the study will be provided with the pillbox organizer and asked to use the pillbox for 1 month. The pillbox contains 7 compartments with embedded sensors that detects if there is a pill present. Blinking lights and a flashing letter specifying the day of the week, are used to alert users to take their medicines. After taking the first dose, a 24-hour count down timer will begin. If the medication specified for that day is not taken within the target time the device will beep to alert the user. Participants will complete a structured interview at baseline and 1 month follow-up to assess demographic and health related information, medication adherence and how they found using the pillbox organizer. Additionally, if individuals have a family member who supports their medication use, they will be asked to complete an interview at the 1 month follow-up to understand how they found using the pillbox organizer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Primary Inclusion Criteria are for older adults who manage multi-drug regimens. Inclusion Criteria:\n\n1. Age 60 or older\n2. Taking 3 or more medications\n3. Takes medications twice per day or less\n4. Adequate cognitive capacity (defined as less than 2 errors on 6 item cognitive screener).\n\nAdditionally, a family member that assists with a participant's medicines can also be invited to participate. The family member eligibility criteria is:\n\n1. Age 18 or older\n2. Support family member taking 3 or medications, twice a day or less\n3. Adequate cognitive capacity (defined as less than 2 errors on 6 item cognitive screener)"}, 'identificationModule': {'nctId': 'NCT06901258', 'briefTitle': 'Genius PillBox Study', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Genius PillBox: Pilot and Feasibility Study', 'orgStudyIdInfo': {'id': 'STU00223484'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Genius Pillbox', 'description': 'Participants receive Genius Pillbox to use for 1 month', 'interventionNames': ['Behavioral: Genius Pillbox']}], 'interventions': [{'name': 'Genius Pillbox', 'type': 'BEHAVIORAL', 'description': 'Participants will be mailed a Genius Pillbox to their home address. Along with the pillbox, they will also receive a detailed written description to orient them to the Genius Pillbox. Participants will be expected to use the Genius pill box organizer daily for four weeks as part of their usual medication routine. Participants are also expected to fill the designated compartments with their daily pills.', 'armGroupLabels': ['Genius Pillbox']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': "Rachel O'Conor, PhD, MPH", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': "Rachel O'Conor", 'investigatorAffiliation': 'Northwestern University'}}}}