Improving Hypertension Medication Adherence for Older Adults

March 5, 2026 updated by: University of Arizona
This randomized controlled trial will assess the efficacy and scalability of a blood pressure technology system intervention. The investigators will enroll 224 older adults with hypertension to identify those who are nonadherent for one hypertension medication. The participants will be randomized to one of two groups (112 per group) to use the blood pressure system for 6-months. Both groups receive information about high blood pressure and medications. One group will also receive strategies that can be used to take medications and manage blood pressure. Both groups will complete a mid-assessment at 3-months and a post-assessment at 6-months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

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 Locations

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

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age 65 years or older
  • self-manage at least one hypertension medication
  • able to read and speak English
  • willing to participate in the study for six months
  • currently have and use an Apple iPhone
  • have hypertension medication adherence ≤ 90% in the last 2 weeks of the 4-week baseline monitoring period using an AARDEX MEMS® cap

Exclusion Criteria:

  • have inadequate visual acuity (worse than 20/50 corrected near vision on Snellen test)
  • experience severe depression (> 11 on Geriatric Depression Scale Short Form, GDS-15)
  • are at risk for cognitive impairment (< 23 on Montreal Cognitive Assessment, MoCA)
  • been instructed by their healthcare provider to withhold their blood pressure medication

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Blood Pressure Technology System M
These participants will receive information about high blood pressure, medications and strategies that can be used to take medications and manage blood pressure. They will complete a mid-assessment at 3-months and a post-assessment at 6-months.
Other: Blood Pressure Technology System M
Participants will be provided the blood pressure technology system M. The study staff will teach the participants how to use the system on their personal cell phones with instruction guides. Participants will be asked to use the system for 6-months.
Other: Blood Pressure Technology System E
These participants receive information about high blood pressure and medications. They will complete a mid-assessment at 3-months and a post-assessment at 6-months.
Other: Blood Pressure Technology System E
Participants will be provided the blood pressure technology system E. The study staff will teach the participants how to use the system on their personal cell phones with instruction guides. Participants will be asked to use the system for 6-months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adherence
Time Frame: Baseline, 3-months, 6-months
Change in adherence (both objective and subjective) after 6 months of M system engagement versus E system use. Objective adherence is measured by Aardex Medication Event Monitoring System (MEMS). Subjective adherence is measured by the five-item Medication Adherence Report Scale (MARS-5). MARS-5 total score ranges between 5 and 25, with higher scores indicating better adherence.
Baseline, 3-months, 6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
systolic blood pressure (BP)
Time Frame: Baseline, 3-months, 6-months
6-month change in mean seated systolic BP among M system users versus E system users.
Baseline, 3-months, 6-months
perceived competence
Time Frame: Baseline, 3-months, 6-months
6-month change in perceived competence among M system users versus E system users. The four-item Perceived Competence Scale (PCS) is used to measure self-determination competence. PCS total score ranges between 4 and 28, with higher scores indicating higher perceived competence with medication adherence.
Baseline, 3-months, 6-months
perceived autonomy
Time Frame: Baseline, 3-months, 6-months
6-month change in perceived autonomy among M system users versus E system users. The Treatment Self-Regulation Questionnaire (TSRQ) is used to measure individual differences in the types of motivation or regulation. Each of the 15 questionnaire items represents a reason for engaging in or changing a health behavior. Responses use a seven-point scale ranging from 1 (not at all true) to 7 (very true). Higher numbers indicate higher autonomous motivation, controlled motivation, or amotivation.
Baseline, 3-months, 6-months
mobile device proficiency
Time Frame: Baseline, 3-months, 6-months
6-month change in mobile device proficiency among M system users versus E system users. Proficiency is measured with the Mobile Device Proficiency Questionnaire (MDPQ-16). The MDPQ-16 total score ranges from 8 to 40, with higher scores reflecting greater proficiency.
Baseline, 3-months, 6-months

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

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)

November 2, 2022

Primary Completion (Actual)

March 14, 2025

Study Completion (Actual)

March 14, 2025

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

November 4, 2022

First Posted (Actual)

November 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01NR018469 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data and resources generated during the performance of the project will be shared with the research community primarily via conference presentations, journal articles, and summary reports made available on laboratory and company websites. Technical manuals created during the project may be made publicly available via websites geared towards sharing resources in the research community or licensed, as appropriate, and after University review. Completely de-identified final data will be shared with existing and new collaborators of the laboratories participating in the project and with new collaborators who may initiate contact by emailing one of the PIs, using HIPAA-compliant file transfer methods once the investigators complete a data-sharing agreement. The data-sharing agreement will ensure that privacy, confidentiality standards, and data security will be maintained at the recipient site and will prohibit manipulation of data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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