bpMedManage: Digital Technology to Support Adherence to Hypertension Medications

October 13, 2025 updated by: Kathleen Insel, University of Arizona

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • Recruiting
        • University of Arizona
        • Contact:
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Recruiting
        • University of Illinois, Urbana-Champaign
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bpMedManage-S
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
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.
Active Comparator: bpMedManage-P
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 4, Week 12
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.
Week 4, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 4, Week 12
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.
Week 4, Week 12
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.
Week 4, Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opinion Interview
Time Frame: Week 12
Understand participant opinions' regarding facilitators and barriers to using the system.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

University of Illinois at Urbana-Champaign

Investigators

  • Principal Investigator: Kathleen Insel, PhD, University of Arizona
  • Principal Investigator: Raksha Mudar, PhD, University of Illinois, Urbana-Champaign

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Estimated)

October 15, 2025

Last Update Submitted That Met QC Criteria

October 13, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002804

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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