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| Name | Class |
|---|---|
| University of Illinois at Urbana-Champaign | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bpMedManage-S | Experimental | Intervention group will use a smartphone application with medication reminders plus receive education with standardized information on hypertension and antihypertensive medications on the education portal. They will complete immediate outcomes assessment 4 weeks after the beginning of the intervention and follow-up outcomes 12 weeks after the beginning of intervention. |
|
| bpMedManage-P | Active Comparator | Participants in the bpMedManage-P group will use a smartphone to receive education with standardized information on hypertension and antihypertensive medications on the education portal. They will complete immediate outcomes assessment 4 weeks after the beginning of the intervention and follow-up outcomes 12 weeks after the beginning of intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bpMedManage | Behavioral | In this 16-week RCT, a total of 100 older adults with MCI will be recruited. There are 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 the 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 will be assessed 4 weeks after beginning of the intervention. Follow-up outcomes will be assessed 12 weeks after the beginning of the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in medication adherence measured by the Medication Event Monitoring System (MEMS® Cap) | A device used to monitor medication adherence. The medication event monitoring system (MEMS) is a cap that fits on medication bottles and records the time and date each time the bottle is opened. Adherence data by MEMS® monitoring will be downloaded to a study laptop from all participants' MEMS® Cap via a USB connected MEMS® cap reader/communicator. | Week 4, Week 12 |
| Change in self-reported medication adherence measured by the Medication Adherence Report Scale-5 (MARS-5© Professor Rob Horne) | 5 items on a 5-point rating scale to assess participant's medication adherence, with lower scores indicating a lower level of adherence. | Week 4, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic and/or Diastolic blood pressure, as measured by taking blood pressure readings | Force of blood pushing against blood vessels while the heart beats. | Week 4, Week 12 |
| Change in hypertension knowledge measured by the Hypertension Knowledge-Level Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Opinion Interview | Understand participant opinions' regarding facilitators and barriers to using the system. | Week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Insel, PhD | Contact | 520-626-6220 | insel@arizona.edu | |
| Raksha Mudar, PhD | Contact | 217-333-4718 | raksha@illinois.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kathleen Insel, PhD | University of Arizona | Principal Investigator |
| Raksha Mudar, PhD | University of Illinois, Urbana-Champaign | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Recruiting | Tucson | Arizona | 85721 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Aardex Group. (n.d.). MEMS® Button Medication Event Monitoring System. https://aardexgroup.com/about-us/ | ||
| 38487251 | Background | Al-Saleh S, Lee J, Rogers W, Insel K. Translation of a Successful Behavioral Intervention to a Digital Therapeutic Self-Management System for Older Adults. Ergon Des. 2024 Apr;32(2):5-13. doi: 10.1177/10648046211066409. Epub 2022 Feb 24. | |
| 22690180 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2024 | Feb 21, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 4, 2023 | Mar 8, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D014652 | Vascular Diseases |
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Participants will be screened and randomly assigned to either the bpMedManage-S or bpMedManage-P group
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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.
|
22-items scale (range: 0-22) with items associated with hypertension, 6 sub-dimensions, and a lower composite score indicating lower knowledge on hypertension. |
| Week 4, Week 12 |
| System Usability measured by the System Usability Scale | Scale (range: 0-100) measures one's perceived usability of a system, with lower scores indicating poor system usability. | Week 4, Week 12 |
| University of Illinois, Urbana-Champaign | Recruiting | Champaign | Illinois | 61820 | United States |
|
| Background |
| Erkoc SB, Isikli B, Metintas S, Kalyoncu C. Hypertension Knowledge-Level Scale (HK-LS): a study on development, validity and reliability. Int J Environ Res Public Health. 2012 Mar;9(3):1018-29. doi: 10.3390/ijerph9031018. Epub 2012 Mar 22. |
| Background | Brooke, J. (1996). SUS: A quick and dirty usability scale. Usability Evaluation in Industry, 189, 4-7. |
| 31823381 | Background | Chan AHY, Horne R, Hankins M, Chisari C. The Medication Adherence Report Scale: A measurement tool for eliciting patients' reports of nonadherence. Br J Clin Pharmacol. 2020 Jul;86(7):1281-1288. doi: 10.1111/bcp.14193. Epub 2020 May 18. |
| 27000329 | Background | Insel KC, Einstein GO, Morrow DG, Koerner KM, Hepworth JT. Multifaceted Prospective Memory Intervention to Improve Medication Adherence. J Am Geriatr Soc. 2016 Mar;64(3):561-8. doi: 10.1111/jgs.14032. |
| 27302310 | Background | Masterson Creber RM, Maurer MS, Reading M, Hiraldo G, Hickey KT, Iribarren S. Review and Analysis of Existing Mobile Phone Apps to Support Heart Failure Symptom Monitoring and Self-Care Management Using the Mobile Application Rating Scale (MARS). JMIR Mhealth Uhealth. 2016 Jun 14;4(2):e74. doi: 10.2196/mhealth.5882. |
| D002318 |
| Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |