Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-25 @ 2:51 PM
Study NCT ID:
NCT03402750
Status:
COMPLETED
Last Update Posted:
2019-11-07
First Post:
2018-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Heart Failure Medication Adherence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055695', 'term': 'Electronic Prescribing'}], 'ancestors': [{'id': 'D055656', 'term': 'Prescriptions'}, {'id': 'D010593', 'term': 'Pharmaceutical Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bmccabe@miami.edu', 'phone': '305-248-1530', 'title': 'Brian McCabe', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': 'Event data collected from interview and medical records', 'eventGroups': [{'id': 'EG000', 'title': 'Meds to Beds', 'description': 'Patients receive medication in-hand at discharge from the hospital\n\nMeds to Beds: Medications will be delivered to patient bedside before discharge', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Standard Care', 'description': 'Electronic prescription with patient pickup at the pharmacy\n\nElectronic Prescription: Patient or surrogate can pick up medication from pharmacy', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adherence to Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meds to Beds', 'description': 'Patients receive medication in-hand at discharge from the hospital\n\nMeds to Beds: Medications will be delivered to patient bedside before discharge'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Electronic prescription with patient pickup at the pharmacy\n\nElectronic Prescription: Patient or surrogate can pick up medication from pharmacy'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'Adherence to medication will be reported as the number of participants that scores 12 and lower in a self-reported Adherence to Refills and Medications Scale (ARMS) Questionnaire. The questionnaire has 12 items with each item being recorded on a four-point Likert scale. The total score ranges from 12-48 with the lower score indicating better adherence.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '4 participants in each condition did not complete this measure.'}, {'type': 'PRIMARY', 'title': 'Pharmacy Refill Adherence to Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meds to Beds', 'description': 'Patients receive medication in-hand at discharge from the hospital\n\nMeds to Beds: Medications will be delivered to patient bedside before discharge'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Electronic prescription with patient pickup at the pharmacy\n\nElectronic Prescription: Patient or surrogate can pick up medication from pharmacy'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'Medication adherence will be reported as the number of participants that completed their expected pharmacy refill. Standard Care participants are expected to complete one initial fill and one refill. Meds to Beds participants are expected to complete one pharmacy refill as the initial fill is handed upon discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on electronic medical record for refills of heart failure medications were only available for 10 participants in Meds to Beds and 11 in Standard Care.'}, {'type': 'SECONDARY', 'title': 'Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meds to Beds', 'description': 'Patients receive medication in-hand at discharge from the hospital\n\nMeds to Beds: Medications will be delivered to patient bedside before discharge'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Electronic prescription with patient pickup at the pharmacy\n\nElectronic Prescription: Patient or surrogate can pick up medication from pharmacy'}], 'classes': [{'title': '30-Day follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.81', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '11.50', 'spread': '3.90', 'groupId': 'OG001'}]}]}, {'title': 'Baseline/Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.56', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '10.19', 'spread': '3.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 30', 'description': 'Physical health is measured using the 10 item PROMIS questionnaire. Responses are recorded along a 5-point Likert scale with a total score ranging from 10-50. A higher score indicates better physical health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Interviews completed at follow-up and baseline. Not all participants completed the PROMIS questionnaire at the 30-day follow up visit.'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Received Their Medications Prior to Discharge.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meds to Beds', 'description': 'Patients receive medication in-hand at discharge from the hospital\n\nMeds to Beds: Medications will be delivered to patient bedside before discharge'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Electronic prescription with patient pickup at the pharmacy\n\nElectronic Prescription: Patient or surrogate can pick up medication from pharmacy'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': "The program's feasibility will be evaluated by tracking whether medications can be successfully delivered (i.e., before discharge) to patients in the Meds to Beds condition. This measure will be evaluated as a proportion within the intervention condition.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in Standard Care arm could receive delivery of medications, contrary to intentions.'}, {'type': 'SECONDARY', 'title': 'Intervention Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meds to Beds', 'description': 'Patients receive medication in-hand at discharge from the hospital\n\nMeds to Beds: Medications will be delivered to patient bedside before discharge'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Electronic prescription with patient pickup at the pharmacy\n\nElectronic Prescription: Patient or surrogate can pick up medication from pharmacy'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'All participants will be asked one question about the acceptability of the intervention program. Responses for acceptability items will be recorded on a 10-point scale (1, very unsatisfactory - 10, very satisfactory). Dichotomized due to extreme skew. Intervention acceptance will be reported as the number of participants that provides a score of 1 and higher.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants completing follow-up interview. Not all participants completed the questionnaire.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Meds to Beds', 'description': 'Patients receive medication in-hand at discharge from the hospital\n\nMeds to Beds: Medications will be delivered to patient bedside before discharge'}, {'id': 'FG001', 'title': 'Standard Care', 'description': 'Electronic prescription with patient pickup at the pharmacy\n\nElectronic Prescription: Patient or surrogate can pick up medication from pharmacy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Meds to Beds', 'description': 'Patients receive medication in-hand at discharge from the hospital\n\nMeds to Beds: Medications will be delivered to patient bedside before discharge'}, {'id': 'BG001', 'title': 'Standard Care', 'description': 'Electronic prescription with patient pickup at the pharmacy\n\nElectronic Prescription: Patient or surrogate can pick up medication from pharmacy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.85', 'spread': '6.54', 'groupId': 'BG000'}, {'value': '58.55', 'spread': '11.18', 'groupId': 'BG001'}, {'value': '58.20', 'spread': '8.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-19', 'size': 213492, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-03T13:44', 'hasProtocol': True}, {'date': '2018-07-19', 'size': 164217, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-03T13:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2018-01-10', 'resultsFirstSubmitDate': '2019-07-15', 'studyFirstSubmitQcDate': '2018-01-10', 'lastUpdatePostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-06', 'studyFirstPostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to Medication', 'timeFrame': 'Day 30', 'description': 'Adherence to medication will be reported as the number of participants that scores 12 and lower in a self-reported Adherence to Refills and Medications Scale (ARMS) Questionnaire. The questionnaire has 12 items with each item being recorded on a four-point Likert scale. The total score ranges from 12-48 with the lower score indicating better adherence.'}, {'measure': 'Pharmacy Refill Adherence to Medication', 'timeFrame': 'Day 30', 'description': 'Medication adherence will be reported as the number of participants that completed their expected pharmacy refill. Standard Care participants are expected to complete one initial fill and one refill. Meds to Beds participants are expected to complete one pharmacy refill as the initial fill is handed upon discharge.'}], 'secondaryOutcomes': [{'measure': 'Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire', 'timeFrame': 'Baseline and Day 30', 'description': 'Physical health is measured using the 10 item PROMIS questionnaire. Responses are recorded along a 5-point Likert scale with a total score ranging from 10-50. A higher score indicates better physical health.'}, {'measure': 'Number of Participants That Received Their Medications Prior to Discharge.', 'timeFrame': 'Day 0', 'description': "The program's feasibility will be evaluated by tracking whether medications can be successfully delivered (i.e., before discharge) to patients in the Meds to Beds condition. This measure will be evaluated as a proportion within the intervention condition."}, {'measure': 'Intervention Acceptance', 'timeFrame': 'Day 30', 'description': 'All participants will be asked one question about the acceptability of the intervention program. Responses for acceptability items will be recorded on a 10-point scale (1, very unsatisfactory - 10, very satisfactory). Dichotomized due to extreme skew. Intervention acceptance will be reported as the number of participants that provides a score of 1 and higher.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adherence, Medication, Prescription'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The objective of this investigation is to pilot test a medication in-hand intervention (Meds to Beds) compared to standard care for patients with heart failure (ICD-50\\[all numbers\\]). The study will evaluate if the intervention improves adherence and physical health, and reduces hospital re-admissions. The study will provide evidence for the feasibility and acceptability of the medication-in-hand intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission diagnosis of heart failure ICD-50, including I50.1, I50.2, I50.20, I50.21, I50.22, I50.23, I50.3, I50.30, I50.31, I50.32, I50.33, I50.4, I50.40, I50.41, I50.42, I50.43, I50.8, I50.81, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89, I50.9, or any combination thereof\n* Age 18 or older\n* New York Heart Association Heart Failure Class II or Class III, with ejection fraction below 45%\n* Cognitively intact, without significant psychological impairment affecting medication adherence such as dementia noted in patient record.\n\nExclusion Criteria:\n\n* Medical conditions, such as active cancer or pregnancy, expected to alter heart failure medication management\n* Discharged to nursing homes or hospice care, where patient may not responsible for their own adherence\n* High risk of loss to follow-up, e.g., leaving the hospital against medical advice, prisoners, living in a homeless shelter, or unable to provide a phone number\n* No plan to fill medications at the Jackson Memorial Hospital pharmacy'}, 'identificationModule': {'nctId': 'NCT03402750', 'briefTitle': 'Heart Failure Medication Adherence', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Heart Failure Medication Adherence Study', 'orgStudyIdInfo': {'id': '20160741'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meds to Beds', 'description': 'Patients receive medication in-hand at discharge from the hospital', 'interventionNames': ['Behavioral: Meds to Beds']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'description': 'Electronic prescription with patient pickup at the pharmacy', 'interventionNames': ['Behavioral: Electronic Prescription']}], 'interventions': [{'name': 'Meds to Beds', 'type': 'BEHAVIORAL', 'description': 'Medications will be delivered to patient bedside before discharge', 'armGroupLabels': ['Meds to Beds']}, {'name': 'Electronic Prescription', 'type': 'BEHAVIORAL', 'description': 'Patient or surrogate can pick up medication from pharmacy', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Jackson Memorial Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Brian E McCabe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beta Tau Chapter of Sigma Theta Tau International', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate Professor', 'investigatorFullName': 'Brian McCabe', 'investigatorAffiliation': 'University of Miami'}}}}