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OpenTrials
Completed

NCT Number: NCT05610059

Improving Hypertension Medication Adherence for Older Adults

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.

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Key information

Conditions

Aging Behavior Cardiovascular Diseases Health Behavior Hypertension Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Blood Pressure Technology System M

Other

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.

Blood Pressure Technology System E

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • University of Illinois at Urbana-Champaign

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 9, 2022
Registry last updated
Mar 9, 2026

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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