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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

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. Medication Adherence (MEMS Cap)

    Time frame: 3 months, 6 months

    The Medication Event Monitoring System (MEMS®Cap) assesses objective medication adherence using the smart pill bottle cap. Digital sensors in the track cap automatically record the date and time of cap opening and upload the information to AARDEX Medication Adherence Software. Percentage of medication taken at the correct time frame.

  2. Medication Adherence Report Scale (MARS-5)

    Time frame: 3 months, 6 months

    The Medication Adherence Report Scale (MARS-5) is a 5-item self-report scale to assess medication adherence related to the frequency of not taking a prescribed dose of medication or not taking the dose prescribed. Self-report score of 5-25. Item scores are summed for a total scale score, where higher scores reflect greater medication adherence. Scale: 5=never, 4=rarely, 3=sometimes, 2=often, and 1=always.

Secondary outcomes

  1. Systolic Blood Pressure (SBP)

    Time frame: Baseline, 3-months, 6-months

    The mean of two seated blood pressure readings taken at least 15 minutes apart using a validated automated device. 6-month change in mean seated systolic BP among M system users versus E system users.

  2. Perceived Autonomy

    Time frame: Baseline, 3-months, 6-months

    The Treatment Self-Regulation Questionnaire (TSRQ) assesses perceived autonomy, treatment-related motivation, and health behavior change. A 15-item questionnaire measures motivation and regulation styles that individuals employ to manage their health-related treatments or behaviors. Scale: 1=Not at all true to 7=Very true. Score 1-7 for each of the following components: TSRQ Autonomous motivation, TSRQ Introjected regulation, TSRQ External regulation, and TSRQ Amotivation. The subscales are averaged to report the mean TSRQ score. Higher numbers indicate higher autonomous motivation, controlled motivation, or amotivation. 6-month change in perceived autonomy among M system users versus E system users.

  3. Perceived Competence

    Time frame: Baseline, 3-months, 6-months

    The Perceived Competence Scale (PCS) is a 4-item questionnaire designed to measure self-perceptions of competence in different contexts (e.g., managing medications). We modified the questions to reflect blood pressure medications. Scale: 1=Not at all true to 7=Very true. Each score on the scale is summed, and a total score is reported (ranges between 4 and 28), with higher scores indicating higher perceived competence with medication adherence. 6-month change in perceived competence among M system users versus E system users.

  4. Mobile Device Proficiency

    Time frame: Baseline, 3-months, 6-months

    The Mobile Device Proficiency Questionnaire (MDPQ) assesses experience with mobile devices, comfort level, and successful use. A 16-item survey measures older adults' proficiency and comfort level in using mobile devices such as smartphones and tablets, including navigating various features and functions. Each questionnaire item is assigned a value from 1 to 5 (1 = Never Tried; 5 = Very Easily). Eight subscale scores are computed by taking the mean of the items within each respective subscale. The overall score is calculated by adding together all subscale scores. The MDPQ-16 total score ranges from 8 to 40, with higher scores reflecting greater proficiency. 6-month change in mobile device proficiency among M system users versus E system users.

  5. Hypertension Knowledge Level Scale

    Time frame: Baseline, 6 months

    The Hypertension Knowledge Level Scale (HK-LS) consists of 22 questions with 6 sub-dimensions and scores, including: HK-LS Definition [0-2], HK-LS Medical treatment [0-4], HK-LS Drug Compliance [0-4], HK-LS Lifestyle [0-5], HK-LS Diet [0-2], and HK-LS Complications [0-5]. The sub-dimension scores are summed to generate an overall score. The HK-LS Overall ranges from 0 to 22, with a higher score indicating higher knowledge about hypertension.

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
Jul 31, 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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