bpMedManage: Digital Technology to Support Adherence to Hypertension Medications

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06307574
• Other study ID #: STUDY00002804
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: University of Arizona
• Contact: Kathleen Insel, PhD
• Phone: 520-626-6220
• Email: insel[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cognitive Dysfunction
• Hypertension
• Mild Cognitive Impairment

Intervention

Behavioral:
• 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 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.

Locations

Country	Name	City	State
United States	University of Illinois, Urbana-Champaign	Champaign	Illinois
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

References & Publications (7)

Aardex Group. (n.d.). MEMS® Button Medication Event Monitoring System. https://aardexgroup.com/about-us/

Al-Saleh, S., Lee, J. K., Rogers, W. A., & Insel, K. C. (2022). Translation of a Successful Behavioral Intervention to a Digital Therapeutic Self-Management System for Older Adults. Ergonomics in Design, 10648046211066408. https://doi.org/10.1177/10648046211066409

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Opinion Interview	Understand participant opinions' regarding facilitators and barriers to using the system.	Week 12
Primary	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
Primary	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
Secondary	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
Secondary	Change in hypertension knowledge measured by the Hypertension Knowledge-Level Scale	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
Secondary	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