Improving Hypertension Medication Adherence for Older Adults

Hypertension Clinical Trial

Official title:

Improving Hypertension Medication Adherence for Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05610059
• Other study ID #: R01NR018469
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Arizona
• Contact: Jeannie K Lee, PharmD
• Phone: 520.626.9419
• Email: jklee[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Hypertension
• Medication Adherence

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Illinois Urbana-Champaign	Champaign	Illinois
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Erratum In: Hypertension. 2018 Jun;71(6):e140-e144. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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