Improving Hypertension Medication Adherence for Older Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Arizona
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- adherence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
All primary and secondary outcomes completed at 3-months and 6-months are blinded.
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Blood Pressure Technology System M (Other)
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.
Intervention: Blood Pressure Technology System E (Other)
Outcomes
Primary Outcomes
adherence
Time Frame: 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.
Medication Adherence (MEMS Cap)
Time Frame: 3 months, 6 months
The Medication Event Monitoring System (MEMS®Cap) assesses objective medication adherence using the smart pill bottle cap. Digital sensors in the track cap automatically record the date and time of cap opening and upload the information to AARDEX Medication Adherence Software. Percentage of medication taken at the correct time frame.
Medication Adherence Report Scale (MARS-5)
Time Frame: 3 months, 6 months
The Medication Adherence Report Scale (MARS-5) is a 5-item self-report scale to assess medication adherence related to the frequency of not taking a prescribed dose of medication or not taking the dose prescribed. Self-report score of 5-25. Item scores are summed for a total scale score, where higher scores reflect greater medication adherence. Scale: 5=never, 4=rarely, 3=sometimes, 2=often, and 1=always.
Secondary Outcomes
- systolic blood pressure (BP)(Baseline, 3-months, 6-months)
- perceived autonomy(Baseline, 3-months, 6-months)
- perceived competence(Baseline, 3-months, 6-months)
- mobile device proficiency(Baseline, 3-months, 6-months)
- Systolic Blood Pressure (SBP)(Baseline, 3-months, 6-months)
- Perceived Autonomy(Baseline, 3-months, 6-months)
- Perceived Competence(Baseline, 3-months, 6-months)
- Mobile Device Proficiency(Baseline, 3-months, 6-months)
- Hypertension Knowledge Level Scale(Baseline, 6 months)