bpMedManage: Digital Technology to Support Adherence to Hypertension Medications

Официальное название

Digital Technology to Support Adherence to Hypertension Medications for Older Adults With Mild Cognitive Impairment

Обзор

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.

Вмешательства

• Поведенческое bpMedManage
  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 edu

Первичные конечные точки

• Change in medication adherence measured by the Medication Event Monitoring System (MEMS® Cap) [Срок оценки: Week 4, Week 12]
• Change in self-reported medication adherence measured by the Medication Adherence Report Scale-5 (MARS-5© Professor Rob Horne) [Срок оценки: Week 4, Week 12]

Вторичные конечные точки (3)

• Change in Systolic and/or Diastolic blood pressure, as measured by taking blood pressure readings [Срок оценки: Week 4, Week 12]
• Change in hypertension knowledge measured by the Hypertension Knowledge-Level Scale [Срок оценки: Week 4, Week 12]
• System Usability measured by the System Usability Scale [Срок оценки: Week 4, Week 12]

Критерии участия

Критерии включения

• Age 60+
• Community-dwelling older adults
• Self-reported fluent in English
• Adequate self-reported visual and hearing ability
• Self-reported memory, thinking, or concentration challenges
• Self-manage at least one prescribed antihypertensive medication
• Have and use a smartphone
• No self-reported history of major depression or other mental health diagnoses
• No self-reported diagnosis of dementia or other neurological disorder such as stroke, TBI, and Parkinson's disease
• TICS-M score between 27-37 and Montreal Cognitive Assessment (MoCA) score between 20-26
• Willing to participate in the study for at least 4 months

Критерии исключения

• Diagnosis of dementia
• Lives in assisted living facility or skilled nursing facility

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 2 центра

• University of Arizona — Tucson
• University of Illinois, Urbana-Champaign — Champaign

Публикации

• Aardex Group. (n.d.). MEMS® Button Medication Event Monitoring System. https://aardexgroup.com/about-us/
• 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. PMID 38487251
• 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. PMID 22690180
• Brooke, J. (1996). SUS: A quick and dirty usability scale. Usability Evaluation in Industry, 189, 4-7.
• 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. PMID 31823381
• 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. PMID 27000329
• 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. PMID 27302310

Идентификаторы

NCT: NCT06307574 · STUDY00002804

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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