Clinical trial NCT06307574: bpMedManage: Digital Technology to Support Adherence to Hypertension Medications
Official title: Digital Technology to Support Adherence to Hypertension Medications for Older Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Mild Cognitive Impairment
Hypertension
Keywords: Digital Health Intervention
Medication Adherence
Mobile Application
Mild Cognitive Impairment
Aging
Hypertension
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: University of Illinois at Urbana-Champaign
First posted: 2024-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be screened and randomly assigned to either the bpMedManage-S or bpMedManage-P group
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Diagnosis of dementia
2. Lives in assisted living facility or skilled nursing facility

Primary outcomes:
measure: Change in medication adherence measured by the Medication Event Monitoring System (MEMS® Cap)
timeFrame: Week 4, Week 12
measure: Change in self-reported medication adherence measured by the Medication Adherence Report Scale-5 (MARS-5© Professor Rob Horne)
timeFrame: Week 4, Week 12
Secondary outcomes:
measure: Change in Systolic and/or Diastolic blood pressure, as measured by taking blood pressure readings
timeFrame: Week 4, Week 12
measure: Change in hypertension knowledge measured by the Hypertension Knowledge-Level Scale
timeFrame: Week 4, Week 12
measure: System Usability measured by the System Usability Scale
timeFrame: Week 4, Week 12
Other outcomes:
measure: Opinion Interview
timeFrame: Week 12
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Champaign
country: United States
facility: University of Illinois, Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Arizona
name: Kathleen Insel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois, Urbana-Champaign
name: Raksha Mudar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aardex Group. (n.d.). MEMS® Button Medication Event Monitoring System. https://aardexgroup.com/about-us/
citation: 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.
citation: 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.
citation: Brooke, J. (1996). SUS: A quick and dirty usability scale. Usability Evaluation in Industry, 189, 4-7.
citation: 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.
citation: 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.
citation: 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.