Improving Hypertension Medication Adherence for Older Adults

Study Overview
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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.

Official Title
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Improving Hypertension Medication Adherence for Older Adults

Conditions
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Aging, Medication Adherence, Hypertension

Intervention / Treatment
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* Other: Blood Pressure Technology System M
* Other: Blood Pressure Technology System E


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be screened and assigned to one of two groups using a blood pressure technology system.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Blood Pressure Technology System M<br>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<br>* 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.<br>|
| Other: Blood Pressure Technology System E<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure (BP) | 6-month change in mean seated systolic BP among M system users versus E system users. | Baseline, 3-months, 6-months | 
| perceived competence | 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. | Baseline, 3-months, 6-months | 
| perceived autonomy | 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. | Baseline, 3-months, 6-months | 
| mobile device proficiency | 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. | Baseline, 3-months, 6-months |