search
Back to results

Improving Hypertension Medication Adherence for Older Adults

Primary Purpose

Aging, Medication Adherence, Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Pressure Technology System M
Blood Pressure Technology System E
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aging

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of ArizonaRecruiting
  • University of Illinois Urbana-ChampaignRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Blood Pressure Technology System M

Blood Pressure Technology System E

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

systolic blood pressure (BP)
6-month change in mean seated systolic BP among M system users versus E system users.
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.
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.
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.

Full Information

First Posted
October 25, 2022
Last Updated
January 26, 2023
Sponsor
University of Arizona
Collaborators
University of Illinois at Urbana-Champaign
search

1. Study Identification

Unique Protocol Identification Number
NCT05610059
Brief Title
Improving Hypertension Medication Adherence for Older Adults
Official Title
Improving Hypertension Medication Adherence for Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
University of Illinois at Urbana-Champaign

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Medication Adherence, Hypertension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be screened and assigned to one of two groups using a blood pressure technology system.
Masking
ParticipantOutcomes Assessor
Masking Description
All primary and secondary outcomes completed at 3-months and 6-months are blinded.
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood Pressure Technology System M
Arm Type
Other
Arm Description
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.
Arm Title
Blood Pressure Technology System E
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
Blood Pressure Technology System M
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Blood Pressure Technology System E
Intervention Description
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.
Primary Outcome Measure Information:
Title
adherence
Description
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.
Time Frame
Baseline, 3-months, 6-months
Secondary Outcome Measure Information:
Title
systolic blood pressure (BP)
Description
6-month change in mean seated systolic BP among M system users versus E system users.
Time Frame
Baseline, 3-months, 6-months
Title
perceived competence
Description
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.
Time Frame
Baseline, 3-months, 6-months
Title
perceived autonomy
Description
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.
Time Frame
Baseline, 3-months, 6-months
Title
mobile device proficiency
Description
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.
Time Frame
Baseline, 3-months, 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeannie K Lee, PharmD
Phone
520.626.9419
Email
jklee@arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy A Rogers, Ph.D.
Phone
217.300.1470
Email
wendyr@illinois.edu
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Skye Nicholas, MS
Phone
520-621-6765
Email
bp-system@pharmacy.arizona.edu
Facility Name
University of Illinois Urbana-Champaign
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renato Azevedo, PhD
Phone
217-300-5445
Email
bp-system@pharmacy.arizona.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data and resources generated during the performance of the project will be shared with the research community primarily via conference presentations, journal articles, and summary reports made available on laboratory and company websites. Technical manuals created during the project may be made publicly available via websites geared towards sharing resources in the research community or licensed, as appropriate, and after University review. Completely de-identified final data will be shared with existing and new collaborators of the laboratories participating in the project and with new collaborators who may initiate contact by emailing one of the PIs, using HIPAA-compliant file transfer methods once the investigators complete a data-sharing agreement. The data-sharing agreement will ensure that privacy, confidentiality standards, and data security will be maintained at the recipient site and will prohibit manipulation of data
Citations:
PubMed Identifier
31823381
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.
Results Reference
background
PubMed Identifier
9773724
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.
Results Reference
background
PubMed Identifier
27255686
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.
Results Reference
background
PubMed Identifier
29133356
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.
Results Reference
background
PubMed Identifier
8862216
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.
Results Reference
background

Learn more about this trial

Improving Hypertension Medication Adherence for Older Adults

We'll reach out to this number within 24 hrs