Clinical trial NCT05610059: Improving Hypertension Medication Adherence for Older Adults
Official title: Improving Hypertension Medication Adherence for Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Medication Adherence
Hypertension
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: University of Illinois at Urbana-Champaign
First posted: 2022-11-09
Enrollment: 224
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be screened and assigned to one of two groups using a blood pressure technology system.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: adherence
timeFrame: Baseline, 3-months, 6-months
Secondary outcomes:
measure: systolic blood pressure (BP)
timeFrame: Baseline, 3-months, 6-months
measure: perceived competence
timeFrame: Baseline, 3-months, 6-months
measure: perceived autonomy
timeFrame: Baseline, 3-months, 6-months
measure: mobile device proficiency
timeFrame: Baseline, 3-months, 6-months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Champaign
country: United States
facility: University of Illinois Urbana-Champaign
state: Illinois
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.