bpMedManage: Digital Technology to Support Adherence to Hypertension Medications

NCT06307574 | Recruiting DMC

• 1 other identifier: STUDY00002804
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Aging; Mild Cognitive Impairment; Hypertension

Keywords

Digital Health Intervention; Medication Adherence; Mobile Application; Mild Cognitive Impairment; Aging; Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Change in Systolic and/or Diastolic blood pressure, as measured by taking blood pressure readings

  Week 4, Week 12

• Change in hypertension knowledge measured by the Hypertension Knowledge-Level Scale

  Week 4, Week 12

• System Usability measured by the System Usability Scale

  Week 4, Week 12

Other Outcomes (1)

• Opinion Interview

  Week 12

Study Arms (2)

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.

Behavioral: bpMedManage

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.

Behavioral: bpMedManage

Interventions

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.

bpMedManage-P; bpMedManage-S

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arizona: lead
• University of Illinois at Urbana-Champaign: collaborator

Study Sites (2)

University of Arizona

Tucson, Arizona, 85721, United States

RECRUITING

University of Illinois, Urbana-Champaign

Champaign, Illinois, 61820, United States

RECRUITING

Related Publications (7)

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

  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.

  PMID: 38487251 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.

  PMID: 22690180 BACKGROUND

• Brooke, J. (1996). SUS: A quick and dirty usability scale. Usability Evaluation in Industry, 189, 4-7.

  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.

  PMID: 31823381 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.

  PMID: 27000329 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.

  PMID: 27302310 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kathleen Insel, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

• Raksha Mudar, PhD

  University of Illinois, Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Insel, PhD

CONTACT

520-626-6220; insel@arizona.edu

Raksha Mudar, PhD

CONTACT

217-333-4718; raksha@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be screened and randomly assigned to either the bpMedManage-S or bpMedManage-P group

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: March 13, 2024
• Study Start: February 29, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2)