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NCT Number: NCT06307574

bpMedManage: Digital Technology to Support Adherence to Hypertension Medications

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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Key information

Conditions

Aging Behavior Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Health Behavior Hypertension Medication Adherence Mental Disorders Mild Cognitive Impairment Neurocognitive Disorders Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Change in medication adherence measured by the Medication Event Monitoring System (MEMS® Cap)

    Time frame: Week 4, Week 12

    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.

  2. Change in self-reported medication adherence measured by the Medication Adherence Report Scale-5 (MARS-5© Professor Rob Horne)

    Time frame: Week 4, Week 12

    5 items on a 5-point rating scale to assess participant's medication adherence, with lower scores indicating a lower level of adherence.

Secondary outcomes

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

    Time frame: Week 4, Week 12

    Force of blood pushing against blood vessels while the heart beats.

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

    Time frame: Week 4, Week 12

    22-items scale (range: 0-22) with items associated with hypertension, 6 sub-dimensions, and a lower composite score indicating lower knowledge on hypertension.

  3. System Usability measured by the System Usability Scale

    Time frame: Week 4, Week 12

    Scale (range: 0-100) measures one's perceived usability of a system, with lower scores indicating poor system usability.

Other outcomes

  1. Opinion Interview

    Time frame: Week 12

    Understand participant opinions' regarding facilitators and barriers to using the system.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen Insel, PhD

CONTACT

[email protected]

520-626-6220

Raksha Mudar, PhD

CONTACT

[email protected]

217-333-4718

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • University of Illinois at Urbana-Champaign

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2024
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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