protocolSection identificationModule nctId: NCT06307574, orgStudyIdInfo id: STUDY00002804, briefTitle: bpMedManage: Digital Technology to Support Adherence to Hypertension Medications, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Arizona, class: OTHER, collaborators name: University of Illinois at Urbana-Champaign, descriptionModule briefSummary: The purpose of the bpMedManage study is to rigorously test the efficacy of a smartphone technology to help improve high blood pressure medication adherence among older adults with mild cognitive impairment (MCI) in a 16-week randomized controlled trial. A total of 100 older adults will be recruited. There will be two treatment arms, bpMedManage-S and bpMedManage-P with 50 participants in each arm. Participants randomized into the bpMEDManage-S intervention arm will use a smartphone application with medication reminders plus receive education with standardized information on hypertension and antihypertensive medications on the education portal. Participants in the bpMedManage-P group will use a smartphone to receive education with standardized information on hypertension and antihypertensive medications on an education portal. Both groups will complete baseline assessments followed by 4 weeks of medication adherence monitoring. At the end of the adherence monitoring period, participants will be randomized into one of the two treatment arms. Immediate outcomes on primary and secondary measures will be assessed 4 weeks after beginning of the intervention. Follow-up outcomes will be assessed 12 weeks after the beginning of the intervention., conditionsModule conditions: Aging, conditions: Mild Cognitive Impairment, conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be screened and randomly assigned to either the bpMedManage-S or bpMedManage-P group, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: All primary and secondary outcome assessments following the intervention, Week 4, are blinded. One of the supplementary outcome measures following the intervention at Week 12, requires the assessor to know the group assignment. This outcome pertains to their experience in the intervention. The follow-up outcome assessments at Week 12 will be administered by an unblinded assessor., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: bpMedManage, outcomesModule primaryOutcomes measure: Change in medication adherence measured by the Medication Event Monitoring System (MEMS® Cap), primaryOutcomes measure: Change in self-reported medication adherence measured by the Medication Adherence Report Scale-5 (MARS-5© Professor Rob Horne), secondaryOutcomes measure: Change in Systolic and/or Diastolic blood pressure, as measured by taking blood pressure readings, secondaryOutcomes measure: Change in hypertension knowledge measured by the Hypertension Knowledge-Level Scale, secondaryOutcomes measure: System Usability measured by the System Usability Scale, otherOutcomes measure: Opinion Interview, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Arizona, status: RECRUITING, city: Tucson, state: Arizona, zip: 85721, country: United States, contacts name: Kathleen Insel, PhD, role: CONTACT, phone: 520-626-6220, email: insel@arizona.edu, geoPoint lat: 32.22174, lon: -110.92648, locations facility: University of Illinois, Urbana-Champaign, status: NOT_YET_RECRUITING, city: Champaign, state: Illinois, zip: 61820, country: United States, contacts name: Raksha Mudar, PhD, role: CONTACT, phone: 217-333-4718, email: raksha@illinois.edu, geoPoint lat: 40.11642, lon: -88.24338, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-02-21, uploadDate: 2024-02-21T16:53, filename: Prot_000.pdf, size: 560648, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-11-04, uploadDate: 2024-03-08T14:33, filename: ICF_001.pdf, size: 563829, hasResults: False