AgingNCT05610059
Improving Hypertension Medication Adherence for Older Adults
A study testing Blood Pressure Technology System M and Blood Pressure Technology System E in people with Aging and Medication Adherence, run by University of Arizona at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging, Medication Adherence, Hypertension
- What is being tested?
- Blood Pressure Technology System M and Blood Pressure Technology System E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Nov 2022to 14 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois Urbana-Champaign
Champaign, Illinois, 61820
University of Arizona
Tucson, Arizona, 85721
About this study
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.
- Conditions
- Aging, Medication Adherence, Hypertension
- Being tested
- Blood Pressure Technology System M, Blood Pressure Technology System E
- Medical subject headings
- Medication Adherence, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Pressure Technology System MOther
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 EOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Blood Pressure Technology System M | Other | 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. Receives: Other: Blood Pressure Technology System M |
| Blood Pressure Technology System E | Other | 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. Receives: Other: Blood Pressure Technology System E |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months, 6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start2 Nov 2022
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be screened and assigned to one of two groups using a blood pressure technology system.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610059
- Sponsor's protocol ID
- R01NR018469
- Status last verified
- Mar 2026
- First submitted
- 25 Oct 2022
- Last updated
- 31 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Chan AHY, Horne R, Hankins M, Chisari C. The Medication Adherence Report Scale: A measurement tool for eliciting patients' reports of nonadherence. Br J Clin Pharmacol. 2020 Jul;86(7):1281-1288. doi: 10.1111/bcp.14193. Epub 2020 May 18.
PubMed 31823381Williams GC, Freedman ZR, Deci EL. Supporting autonomy to motivate patients with diabetes for glucose control. Diabetes Care. 1998 Oct;21(10):1644-51. doi: 10.2337/diacare.21.10.1644.
PubMed 9773724Roque NA, Boot WR. A New Tool for Assessing Mobile Device Proficiency in Older Adults: The Mobile Device Proficiency Questionnaire. J Appl Gerontol. 2018 Feb;37(2):131-156. doi: 10.1177/0733464816642582. Epub 2016 Apr 11.
PubMed 27255686Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065. Epub 2017 Nov 13. No abstract available.
PubMed 29133356Lee JY, Kusek JW, Greene PG, Bernhard S, Norris K, Smith D, Wilkening B, Wright JT Jr. Assessing medication adherence by pill count and electronic monitoring in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study. Am J Hypertens. 1996 Aug;9(8):719-25. doi: 10.1016/0895-7061(96)00056-8.
PubMed 8862216
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Hypertension Medication Adherence for Older Adults
- ClinicalTrials.gov ID
- NCT05610059
- Acronym / sponsor ID
- R01NR018469
- Conditions
- Aging, Medication Adherence, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- University of Illinois at Urbana-Champaign
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Posted 31 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be screened and assigned to one of two groups using a blood pressure technology system.
| Arm | Type | Receives |
|---|---|---|
| Blood Pressure Technology System M | Other | Other: Blood Pressure Technology System MThese 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. |
| Blood Pressure Technology System E | Other | Other: Blood Pressure Technology System EThese 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Pressure Technology System MParticipants 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 M |
| Blood Pressure Technology System EParticipants 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. | Other | Blood Pressure Technology System E |
Primary outcome
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.
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.
5 secondary outcomes
Systolic Blood Pressure (SBP)
Time frame: Baseline, 3-months, 6-months
Perceived Autonomy
Time frame: Baseline, 3-months, 6-months
Perceived Competence
Time frame: Baseline, 3-months, 6-months
Mobile Device Proficiency
Time frame: Baseline, 3-months, 6-months
Hypertension Knowledge Level Scale
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31823381Chan AHY, Horne R, Hankins M, Chisari C. The Medication Adherence Report Scale: A measurement tool for eliciting patients' reports of nonadherence. Br J Clin Pharmacol. 2020 Jul;86(7):1281-1288. doi: 10.1111/bcp.14193. Epub 2020 May 18.
- Background: PubMed 9773724Williams GC, Freedman ZR, Deci EL. Supporting autonomy to motivate patients with diabetes for glucose control. Diabetes Care. 1998 Oct;21(10):1644-51. doi: 10.2337/diacare.21.10.1644.
- Background: PubMed 27255686Roque NA, Boot WR. A New Tool for Assessing Mobile Device Proficiency in Older Adults: The Mobile Device Proficiency Questionnaire. J Appl Gerontol. 2018 Feb;37(2):131-156. doi: 10.1177/0733464816642582. Epub 2016 Apr 11.
- Background: PubMed 29133356Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065. Epub 2017 Nov 13. No abstract available.
- Background: PubMed 8862216Lee JY, Kusek JW, Greene PG, Bernhard S, Norris K, Smith D, Wilkening B, Wright JT Jr. Assessing medication adherence by pill count and electronic monitoring in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study. Am J Hypertens. 1996 Aug;9(8):719-25. doi: 10.1016/0895-7061(96)00056-8.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Pressure Technology System M and Blood Pressure Technology System E in people with Aging and Medication Adherence, run by University of Arizona at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (MEMS Cap) (time frame: 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05610059, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.