nctId: NCT06307574 id: STUDY00002804 briefTitle: bpMedManage: Digital Technology to Support Adherence to Hypertension Medications overallStatus: RECRUITING date: 2024-02-29 date: 2025-05 date: 2025-12 date: 2024-03-13 date: 2024-04-01 name: University of Arizona class: OTHER name: University of Illinois at Urbana-Champaign 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. conditions: Aging conditions: Mild Cognitive Impairment conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be screened and randomly assigned to either the bpMedManage-S or bpMedManage-P group primaryPurpose: OTHER 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 count: 100 type: ESTIMATED name: bpMedManage measure: Change in medication adherence measured by the Medication Event Monitoring System (MEMS® Cap) measure: Change in self-reported medication adherence measured by the Medication Adherence Report Scale-5 (MARS-5© Professor Rob Horne) measure: Change in Systolic and/or Diastolic blood pressure, as measured by taking blood pressure readings measure: Change in hypertension knowledge measured by the Hypertension Knowledge-Level Scale measure: System Usability measured by the System Usability Scale measure: Opinion Interview sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Arizona status: RECRUITING city: Tucson state: Arizona zip: 85721 country: United States name: Kathleen Insel, PhD role: CONTACT phone: 520-626-6220 email: insel@arizona.edu lat: 32.22174 lon: -110.92648 facility: University of Illinois, Urbana-Champaign status: NOT_YET_RECRUITING city: Champaign state: Illinois zip: 61820 country: United States name: Raksha Mudar, PhD role: CONTACT phone: 217-333-4718 email: raksha@illinois.edu lat: 40.11642 lon: -88.24338 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 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