Improving Hypertension Medication Adherence for Older Adults

Not Applicable

Recruiting

• Conditions: Aging; Medication Adherence; Hypertension
• Interventions: Other: Blood Pressure Technology System M; Other: Blood Pressure Technology System E

• Registration Number: NCT05610059
• Lead Sponsor: University of Arizona

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-25
• Study Start: 2022-11-02
• Study First Submitted QC: 2022-11-04
• Study First Posted: 2022-11-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood Pressure Technology System M	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.
Blood Pressure Technology System E	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.

Primary Outcome Measures

Name	Time	Method
adherence	Baseline, 3-months, 6-months	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.

Secondary Outcome Measures

Name	Time	Method
systolic blood pressure (BP)	Baseline, 3-months, 6-months	6-month change in mean seated systolic BP among M system users versus E system users.
perceived autonomy	Baseline, 3-months, 6-months	6-month change in perceived autonomy among M system users versus E system users. The Treatment Self-Regulation Questionnaire (TSRQ) is used to measure individual differences in the types of motivation or regulation. Each of the 15 questionnaire items represents a reason for engaging in or changing a health behavior. Responses use a seven-point scale ranging from 1 (not at all true) to 7 (very true). Higher numbers indicate higher autonomous motivation, controlled motivation, or amotivation.
perceived competence	Baseline, 3-months, 6-months	6-month change in perceived competence among M system users versus E system users. The four-item Perceived Competence Scale (PCS) is used to measure self-determination competence. PCS total score ranges between 4 and 28, with higher scores indicating higher perceived competence with medication adherence.
mobile device proficiency	Baseline, 3-months, 6-months	6-month change in mobile device proficiency among M system users versus E system users. Proficiency is measured with the Mobile Device Proficiency Questionnaire (MDPQ-16). The MDPQ-16 total score ranges from 8 to 40, with higher scores reflecting greater proficiency.

Trial Locations

Locations (2)

University of Illinois Urbana-Champaign; 🇺🇸 Champaign, Illinois, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States