Improving Hypertension Medication Adherence for Older Adults

NCT ID: NCT05610059

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-02

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aging Medication Adherence Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be screened and assigned to one of two groups using a blood pressure technology system.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
All primary and secondary outcomes completed at 3-months and 6-months are blinded.

Study Groups

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Blood Pressure Technology System M

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.

Group Type OTHER

Blood Pressure Technology System M

Intervention Type 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

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.

Group Type OTHER

Blood Pressure Technology System E

Intervention Type 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.

Interventions

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Blood Pressure Technology System M

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.

Intervention Type OTHER

Blood Pressure Technology System E

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Urbana-Champaign

OTHER

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

University of Illinois Urbana-Champaign

Champaign, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31823381 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9773724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27255686 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29133356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8862216 (View on PubMed)

Other Identifiers

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R01NR018469

Identifier Type: NIH

Identifier Source: org_study_id

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