Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT06175793
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2023-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ASPIRE: Adapting Self-Blood Pressure Monitoring to Reduce Health Disparities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2023-12-08', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient and Care Team Acceptability', 'timeFrame': '1 month', 'description': 'Patient and care team acceptability of the research methods and ASPIRE components will be evaluated based on in-depth interviews.'}, {'measure': 'Patients and Care Team Satisfaction', 'timeFrame': '1 month', 'description': 'Patient and care team satisfaction with the research methods and ASPIRE components will be evaluated based on in-depth interviews.'}], 'primaryOutcomes': [{'measure': 'SMBP Feasibility', 'timeFrame': '1 month', 'description': "Feasibility of study methods will be evaluated using EHR data and returned SMBP logs and will include recruitment rates following patient's hypertension visits and loss to follow up rate over the 1 month follow up period."}], 'secondaryOutcomes': [{'measure': 'Change in systolic blood pressure (SBP)', 'timeFrame': '3 months', 'description': 'difference in the mean change in SBP (mmHg) between the intervention and control arms'}, {'measure': 'Change in diastolic blood pressure (DBP)', 'timeFrame': '3 months', 'description': 'difference in the mean change in DBP (mmHg) between the intervention and control arms'}, {'measure': 'Blood pressure control', 'timeFrame': '3 months', 'description': 'proportion of patients with controlled blood pressure (mmHg)'}, {'measure': 'Medication intensification', 'timeFrame': '3 months', 'description': 'proportion of patients who had a medication intensification.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '40562882', 'type': 'DERIVED', 'citation': 'Khatib R, Glowacki N, Guzman I, Ozoani O, Brill J, Lauffenburger JC, Biskis A, Gordon M. Adopting Self-Measured Blood Pressure Monitoring Among Underserved Communities (ASPIRE): A Pilot Randomized Controlled Trial. J Gen Intern Med. 2025 Jun 25. doi: 10.1007/s11606-025-09646-9. Online ahead of print.'}, {'pmid': '39815379', 'type': 'DERIVED', 'citation': 'Khatib R, Glowacki N, Guzman I, Shields M, Chase J, Gordon M. Adapting self-measured blood pressure monitoring to reduce health disparities (ASPIRE): a pilot hybrid effectiveness-implementation study protocol. Pilot Feasibility Stud. 2025 Jan 15;11(1):7. doi: 10.1186/s40814-024-01588-z.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to implement a pilot focusing on developing training manuals and materials for patients and the clinical team to ensure our intervention is delivered consistently and systematically for each patient.', 'detailedDescription': "Barriers to blood pressure control are multi-faceted and a silver-bullet solution/intervention does not exist. Therefore, the literature highlights the importance of creating multi-component interventions when addressing blood pressure control. The ASPIRE intervention consists of 5 components identified based on the study team's prior work and review of the literature.\n\nPatients randomized to the intervention arm will receive all 5 components of the ASPIRE intervention. Patients randomized to the control arm will receive only the first component of the ASPIRE intervention and will continue to receive usual care. The ASPIRE intervention consists of 5 components aimed at supporting both patients and clinic care teams in successfully adopting self-measured blood pressure (SMBP) into their clinic workflow.\n\nThe 5 ASPIRE components are:\n\n1. Access to cuff (Patient). Patients in the intervention arm and control arm will be measured for and will receive a blood pressure monitoring device to take home and keep beyond the study timeline.\n2. Training (Patient). Only patients in the intervention arm will receive training and support on how to accurately measure their blood pressure. They will receive a folder containing an infographic that demonstrates how to accurately measure blood pressure at home. They will also receive a lifestyle infographic describing what they can do to improve their blood pressure.\n3. Clear instructions (Patient). Patients in the intervention arm will also receive clear instructions on how to keep a record of their home blood pressure measures and share with their care team. They will be provided with a 7-day blood pressure long that details the number of blood pressure values they need to take in the mornings and evenings for seven days. Additionally, a clinic care team member serving as the ASPIRE coach will follow up with the intervention patients via a scheduled virtual call one week after they receive their materials (blood pressure monitoring device, infographics, and 7-day blood pressure log) to provide further support and instructions on self-measured blood pressure and to emphasize the importance of returning the blood pressure values to their care team.\n4. SMBP EHR Documentation (ASPIRE Coach). To facilitate documentation of home blood pressure values in the electronic health record (EHR), the ASPIRE coach will average the blood pressure values patients return and document that average in the EHR. These home blood pressure averages will be shared with the patient's doctor who can use these values to modify treatment as appropriate.\n5. Address Social Determinants of Health (Patient). Patients will be screened for social needs via a social determinants of health (SDOH) questionnaire that they will be asked to return to the care team. During the one week follow up virtual call the ASPIRE coach will address any identified social needs by following up with referrals as needed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Patients:\n\nInclusion Criteria:\n\n* Adults \\>=18 years old\n* At least a 1-year history of hypertension\n* Must have at least one clinic visit during the study recruitment period (qualifying visit)\n* An elevated blood pressure value during their qualifying visit (defined as SBP above 140mm/Hg or DBP above 90mm/Hg)\n* Must be on at least one blood pressure lowering medication\n* Able to provide consent\n\nExclusion Criteria:\n\n* Patients residing in a nursing home or receiving home health care\n* Patients that don't speak English\n\nProviders:\n\nInclusion Criteria: Care team members who participate in the study clinic."}, 'identificationModule': {'nctId': 'NCT06175793', 'briefTitle': 'ASPIRE: Adapting Self-Blood Pressure Monitoring to Reduce Health Disparities', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'ASPIRE: Adapting Self-Blood Pressure Monitoring to Reduce Health Disparities', 'orgStudyIdInfo': {'id': 'IRB00104818'}, 'secondaryIdInfos': [{'id': '22.075E', 'type': 'OTHER', 'domain': 'Advocate HC IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASPIRE Intervention Arm', 'description': 'The intervention arm will receive usual care, a free blood pressure cuff in addition to the ASPIRE Components.', 'interventionNames': ['Behavioral: ASPIRE Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'The control group will receive usual care and a free blood pressure cuff.'}], 'interventions': [{'name': 'ASPIRE Intervention', 'type': 'BEHAVIORAL', 'description': 'In addition to usual care and a free blood pressure cuff, participants in the intervention arm will receive the ASPIRE components: (1) ASPIRE Tool Kit, (2) ASPIRE Coach, (3) SMBP EHR Documentation, and (4) screening and addressing SDOHs.', 'armGroupLabels': ['ASPIRE Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': 'ADMG Oak Lawn IM Clinci', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}], 'overallOfficials': [{'name': 'Rasha Khatib, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advocate Aurora Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}