An interventional study of Blood Pressure Technology System M and Blood Pressure Technology System E in Aging, Medication Adherence and Hypertension, sponsored by University of Arizona. Completed at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by University of Arizona · Not applicable, Interventional, and Other
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.
223 studies on the registry are indexed under Medication Adherence; 108 are open to participants now.
This study's enrollment of 200 is above the median of 118 across 189 interventional studies indexed under Medication Adherence.
Browse Medication Adherence studies →University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 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.
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.
Medication Adherence (MEMS Cap)
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.
Time frame: 3 months, 6 months
Medication Adherence Report Scale (MARS-5)
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.
Time frame: 3 months, 6 months
Systolic Blood Pressure (SBP)
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.
Time frame: Baseline, 3-months, 6-months
Perceived Autonomy
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.
Time frame: Baseline, 3-months, 6-months
Perceived Competence
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.
Time frame: Baseline, 3-months, 6-months
Mobile Device Proficiency
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.
Time frame: Baseline, 3-months, 6-months
Hypertension Knowledge Level Scale
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.
Time frame: Baseline, 6 months
| Milestone | Blood Pressure Technology System M | Blood Pressure Technology System E | Enrolled But Not Randomized/Treated |
|---|---|---|---|
| Started | 34 | 32 | 134 |
| Completed | 27 | 30 | 0 |
| Not completed | 7 | 2 | 134 |
| Withdrew: Adherence >90% after 28-day monitoring period | 0 | 0 | 134 |
| Withdrew: Lost to follow-up | 7 | 2 | 0 |
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.
| Percentage | Blood Pressure Technology System M | Blood Pressure Technology System E |
|---|---|---|
| 3 months | 67.29 ± 0.31 | 53.72 ± 0.32 |
| 6 months | 63.47 ± 0.32 | 53.56 ± 0.36 |
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.
| mm Hg | Blood Pressure Technology System M | Blood Pressure Technology System E |
|---|---|---|
| Baseline | 131.93 ± 17.93 | 133.44 ± 20.06 |
| 3 months | 133.29 ± 15.27 | 129.34 ± 17.13 |
| 6 months | 134.63 ± 18.65 | 130.59 ± 21.04 |
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.
| Score on a scale | Blood Pressure Technology System M | Blood Pressure Technology System E |
|---|---|---|
| Baseline | 6.66 ± 0.50 | 6.65 ± 0.49 |
| 3 months | 6.80 ± 0.38 | 6.66 ± 0.49 |
| 6 months | 6.84 ± 0.35 | 6.76 ± 0.49 |
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.
| Score on a scale | Blood Pressure Technology System M | Blood Pressure Technology System E |
|---|---|---|
| Baseline | 24.88 ± 4.99 | 25.94 ± 3.60 |
| 3 months | 25.00 ± 4.90 | 25.59 ± 3.56 |
| 6 months | 25.29 ± 4.86 | 26.16 ± 3.33 |
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.
| Score on a scale | Blood Pressure Technology System M | Blood Pressure Technology System E |
|---|---|---|
| Baseline | 32.93 ± 6.62 | 33.88 ± 5.73 |
| 3 months | 33.26 ± 6.00 | 34.58 ± 4.58 |
| 6 months | 33.21 ± 6.89 | 34.41 ± 5.21 |
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.
| Score on a scale | Blood Pressure Technology System M | Blood Pressure Technology System E |
|---|---|---|
| 3 months | 23.62 ± 1.83 | 24.00 ± 1.48 |
| 6 months | 23.94 ± 1.48 | 23.66 ± 1.68 |
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.
| Score on a scale | Blood Pressure Technology System M | Blood Pressure Technology System E |
|---|---|---|
| Baseline | 18.02 ± 2.72 | 17.97 ± 2.52 |
| 6 months | 18.62 ± 2.57 | 18.59 ± 3.17 |
Collected over 1 month baseline assessment to 6 months follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Blood Pressure Technology System M | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Blood Pressure Technology System E | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Enrolled But Not Randomized/Treated | 0/134 (0%) | 0/134 (0%) | 0/134 (0%) |
| Age, Continuous(years) | Blood Pressure Technology System M | Blood Pressure Technology System E | Enrolled But Not Randomized/Treated | Total |
|---|---|---|---|---|
| Mean | 75.26 ± 6.65 | 74.00 ± 7.44 | 74.16 ± 6.04 | 74.65 ± 7.02 |
| Sex: Female, Male(Participants) | Blood Pressure Technology System M | Blood Pressure Technology System E | Enrolled But Not Randomized/Treated | Total |
|---|---|---|---|---|
| Female | 23 | 27 | 76 | 126 |
| Male | 11 | 5 | 58 | 74 |
| Race (NIH/OMB)(Participants) | Blood Pressure Technology System M | Blood Pressure Technology System E | Enrolled But Not Randomized/Treated | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 | 2 |
| Asian | 3 | 0 | 4 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 |
| Black or African American | 2 | 2 | 1 | 5 |
| White | 27 | 28 | 124 | 179 |
| More than one race | 1 | 0 | 1 | 2 |
| Unknown or Not Reported | 0 | 2 | 2 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Blood Pressure Technology System M | Blood Pressure Technology System E | Enrolled But Not Randomized/Treated | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 2 | 5 |
| Not Hispanic or Latino | 32 | 31 | 132 | 195 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Blood Pressure Technology System M | Blood Pressure Technology System E | Enrolled But Not Randomized/Treated | Total |
|---|---|---|---|---|
| United States | 34 | 32 | 134 | 200 |
| Medication adherence (MEMS Cap)(Percentage) | Blood Pressure Technology System M | Blood Pressure Technology System E | Enrolled But Not Randomized/Treated | Total |
|---|---|---|---|---|
| Mean | 62.76 ± 28.32 | 70.72 ± 22.20 | 96.40 ± 3.23 | 66.62 ± 25.66 |
| Medication Adherence Report Scale (MARS-5)(Score on a scale) | Blood Pressure Technology System M | Blood Pressure Technology System E | Enrolled But Not Randomized/Treated | Total |
|---|---|---|---|---|
| Mean | 24.03 ± 1.17 | 23.69 ± 1.38 | 24.26 ± 1.28 | 23.86 ± 1.28 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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
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University of Arizona