NCT05610059

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

November 2, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 9, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2025

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

October 25, 2022

Last Update Submit

March 5, 2026

Conditions

AgingMedication AdherenceHypertension

Outcome Measures

Primary Outcomes (1)

  • adherence

    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.

    Baseline, 3-months, 6-months

Secondary Outcomes (4)

  • systolic blood pressure (BP)

    Baseline, 3-months, 6-months

  • perceived competence

    Baseline, 3-months, 6-months

  • perceived autonomy

    Baseline, 3-months, 6-months

  • mobile device proficiency

    Baseline, 3-months, 6-months

Study Arms (2)

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.

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.

Other: Blood Pressure Technology System E

Interventions

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.

Blood Pressure Technology System E
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 M

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arizona

Tucson, Arizona, 85721, United States

Location

University of Illinois Urbana-Champaign

Champaign, Illinois, 61820, United States

Location

Related Publications (5)

  • 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.

    PMID: 31823381BACKGROUND

  • Williams 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.

    PMID: 9773724BACKGROUND

  • Roque 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.

    PMID: 27255686BACKGROUND

  • Whelton 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.

    PMID: 29133356BACKGROUND

  • Lee 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.

    PMID: 8862216BACKGROUND

MeSH Terms

Conditions

Medication AdherenceHypertension

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
All primary and secondary outcomes completed at 3-months and 6-months are blinded.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be screened and assigned to one of two groups using a blood pressure technology system.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2022

First Posted

November 9, 2022

Study Start

November 2, 2022

Primary Completion

March 14, 2025

Study Completion

March 14, 2025

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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

Locations

US(2)