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AgingNCT06307574

bpMedManage: Digital Technology to Support Adherence to Hypertension Medications

A study testing bpMedManage in people with Aging and Mild Cognitive Impairment, run by University of Arizona at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of the bpMedManage study is to rigorously test the efficacy of a smartphone technology to help improve high blood pressure medication adherence among older adults with mild cognitive impairment (MCI) in a 16-week randomized controlled trial. A total of 100 older adults will be recruited. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Aging, Mild Cognitive Impairment, Hypertension
What is being tested?
bpMedManage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesUnited States
Study dates
29 Feb 2024to 30 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 60+
  • Community-dwelling older adults
  • Self-reported fluent in English
  • Adequate self-reported visual and hearing ability
  • Self-reported memory, thinking, or concentration challenges
  • Self-manage at least one prescribed antihypertensive medication
Show all 11Show fewer
  • Have and use a smartphone
  • No self-reported history of major depression or other mental health diagnoses
  • No self-reported diagnosis of dementia or other neurological disorder such as stroke, TBI, and Parkinson's disease
  • TICS-M score between 27-37 and Montreal Cognitive Assessment (MoCA) score between 20-26
  • Willing to participate in the study for at least 4 months

Who cannot join

  • Diagnosis of dementia
  • Lives in assisted living facility or skilled nursing facility

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kathleen Insel, PhD contact

520-626-6220

insel@arizona.edu

Raksha Mudar, PhD contact

217-333-4718

raksha@illinois.edu

United States2 sites, 2 recruiting

  • University of Illinois, Urbana-Champaign

    Champaign, Illinois, 61820

    Raksha Mudar, PhD, 217-333-4718, raksha@illinois.edu

    Recruiting

  • University of Arizona

    Tucson, Arizona, 85721

    Kathleen Insel, PhD, 520-626-6220, insel@arizona.edu

    Recruiting

Other trials in United States

About this study

Official title: Digital Technology to Support Adherence to Hypertension Medications for Older Adults With Mild Cognitive Impairment

The purpose of the bpMedManage study is to rigorously test the efficacy of a smartphone technology to help improve high blood pressure medication adherence among older adults with mild cognitive impairment (MCI) in a 16-week randomized controlled trial. A total of 100 older adults will be recruited. There will be two treatment arms, bpMedManage-S and bpMedManage-P with 50 participants in each arm. Participants randomized into the bpMEDManage-S intervention arm will use a smartphone application with medication reminders plus receive education with standardized information on hypertension and antihypertensive medications on the education portal. Participants in the bpMedManage-P group will use a smartphone to receive education with standardized information on hypertension and antihypertensive medications on an education portal. Both groups will complete baseline assessments followed by 4 weeks of medication adherence monitoring. At the end of the adherence monitoring period, participants will be randomized into one of the two treatment arms. Immediate outcomes on primary and secondary measures will be assessed 4 weeks after beginning of the intervention. Follow-up outcomes will be assessed 12 weeks after the beginning of the intervention.

Being tested
bpMedManage
Keywords
Digital Health Intervention, Medication Adherence, Mobile Application, Mild Cognitive Impairment, Aging, Hypertension
Medical subject headings
Cognitive Dysfunction, Hypertension, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bpMedManageBehavioural

    In this 16-week RCT, a total of 100 older adults with MCI will be recruited. There are two treatment arms, bpMedManage-S and bpMedManage-P with 50 participants in each arm. Participants randomized into the bpMEDManage-S intervention arm will use a smartphone application with medication reminders plus receive education with standardized information on hypertension and antihypertensive medications on the education portal. Participants in the bpMedManage-P group will use a smartphone to receive education with standardized information on hypertension and antihypertensive medications on the education portal. Both groups will complete baseline assessments followed by 4 weeks of medication adherence monitoring. At the end of the adherence monitoring period, participants will be randomized into one of the two treatment arms. Immediate outcomes will be assessed 4 weeks after beginning of the intervention. Follow-up outcomes will be assessed 12 weeks after the beginning of the intervention.

Study groups in NCT06307574
Study groupRoleWhat they receive
bpMedManage-SExperimentalIntervention group will use a smartphone application with medication reminders plus receive education with standardized information on hypertension and antihypertensive medications on the education portal. They will complete immediate outcomes assessment 4 weeks after the beginning of the intervention and follow-up outcomes 12 weeks after the beginning of intervention.
Receives: Behavioral: bpMedManage
bpMedManage-PActive comparatorParticipants in the bpMedManage-P group will use a smartphone to receive education with standardized information on hypertension and antihypertensive medications on the education portal. They will complete immediate outcomes assessment 4 weeks after the beginning of the intervention and follow-up outcomes 12 weeks after the beginning of intervention.
Receives: Behavioral: bpMedManage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in medication adherence measured by the Medication Event Monitoring System (MEMS® Cap)

    A device used to monitor medication adherence. The medication event monitoring system (MEMS) is a cap that fits on medication bottles and records the time and date each time the bottle is opened. Adherence data by MEMS® monitoring will be downloaded to a study laptop from all participants' MEMS® Cap via a USB connected MEMS® cap reader/communicator.

    Measured: Week 4, Week 12

  2. Change in self-reported medication adherence measured by the Medication Adherence Report Scale-5 (MARS-5© Professor Rob Horne)

    5 items on a 5-point rating scale to assess participant's medication adherence, with lower scores indicating a lower level of adherence.

    Measured: Week 4, Week 12

Secondary outcomes (3)

  1. Change in Systolic and/or Diastolic blood pressure, as measured by taking blood pressure readings

    Force of blood pushing against blood vessels while the heart beats.

    Measured: Week 4, Week 12

  2. Change in hypertension knowledge measured by the Hypertension Knowledge-Level Scale

    22-items scale (range: 0-22) with items associated with hypertension, 6 sub-dimensions, and a lower composite score indicating lower knowledge on hypertension.

    Measured: Week 4, Week 12

  3. System Usability measured by the System Usability Scale

    Scale (range: 0-100) measures one's perceived usability of a system, with lower scores indicating poor system usability.

    Measured: Week 4, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study start29 Feb 2024
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

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 randomly assigned to either the bpMedManage-S or bpMedManage-P group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06307574
Sponsor's protocol ID
STUDY00002804
Status last verified
Oct 2025
First submitted
12 Feb 2024
Last updated
15 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Aardex Group. (n.d.). MEMS® Button Medication Event Monitoring System. https://aardexgroup.com/about-us/

  • Al-Saleh S, Lee J, Rogers W, Insel K. Translation of a Successful Behavioral Intervention to a Digital Therapeutic Self-Management System for Older Adults. Ergon Des. 2024 Apr;32(2):5-13. doi: 10.1177/10648046211066409. Epub 2022 Feb 24.

    PubMed 38487251

  • Erkoc SB, Isikli B, Metintas S, Kalyoncu C. Hypertension Knowledge-Level Scale (HK-LS): a study on development, validity and reliability. Int J Environ Res Public Health. 2012 Mar;9(3):1018-29. doi: 10.3390/ijerph9031018. Epub 2012 Mar 22.

    PubMed 22690180

  • Brooke, J. (1996). SUS: A quick and dirty usability scale. Usability Evaluation in Industry, 189, 4-7.

  • 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 31823381

  • Insel KC, Einstein GO, Morrow DG, Koerner KM, Hepworth JT. Multifaceted Prospective Memory Intervention to Improve Medication Adherence. J Am Geriatr Soc. 2016 Mar;64(3):561-8. doi: 10.1111/jgs.14032.

    PubMed 27000329

  • Masterson Creber RM, Maurer MS, Reading M, Hiraldo G, Hickey KT, Iribarren S. Review and Analysis of Existing Mobile Phone Apps to Support Heart Failure Symptom Monitoring and Self-Care Management Using the Mobile Application Rating Scale (MARS). JMIR Mhealth Uhealth. 2016 Jun 14;4(2):e74. doi: 10.2196/mhealth.5882.

    PubMed 27302310

Questions about this trial

What is this clinical trial studying?

A study testing bpMedManage in people with Aging and Mild Cognitive Impairment, 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 11 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Oct 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kathleen Insel, PhD (520-626-6220, insel@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in medication adherence measured by the Medication Event Monitoring System (MEMS® Cap) (time frame: Week 4, Week 12). 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 NCT06307574, which also lists 7 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 15 Oct 2025.

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