SMBP Study: Improving High Blood Pressure in Older Adults With Multiple Chronic Diseases

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Korey Kennelty
Study ID
NCT06932029
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SMBP with clinical pharmacist support — BEHAVIORAL
    Self-measured blood pressure with clinical pharmacist support

Study Details

Nearly half of adults in the United States (47 percent, or 116 million) have hypertension, also known as high blood pressure (BP). Uncontrolled high BP can be devasting as it can lead to stroke, heart attack and kidney failure, as well as other numerous health conditions. Hypertension can be controlled; however, only one in four of adults with hypertension have their BP controlled. The chance of having high BP increases as one ages, requiring the need to examine effective hypertension strategies in older adults. The issue of hypertension management is compounded even further among older U.S. adults who live with multiple chronic diseases. National organizations identified several effective health systems strategies for improving rates of BP control, including patient self-measured blood pressure (SMBP) monitoring. SMBP involves a patient's regular use of personal BP monitoring devices to assess and record BP across different points in time, typically at home. The evidence base for utilizing SMBP strategies in healthcare systems and practices is strong. However, there is not research regarding SMBP including how to include it into workflow in primary care clinics. Previous research has shown SMBP is beneficial, but more information is needed regarding whether SMBP is beneficial in high-risk populations (such as rural, older adults or Black, older patients). The research team will test whether SMBP with normal clinical support vs SMBP with clinical pharmacist support improves BP in older adults living with multiple chronic conditions. The addition of a pharmacist has been shown to improve patient outcomes, though the effectiveness of SMBP with a clinical pharmacist in older adults is not known. The primary outcome will be change in systolic BP over 12 months. The secondary outcome will be self-reported treatment burden over 12 months, using a validated tool called the Multimorbidity Treatment Burden Questionnaire. The research team plans to include a subgroup of rural, older adults and Black, older adults and will not exclude older adults who have dementia.

Key Dates

Start date
Jul 1, 2025
Status verified
Oct 2025
Primary completion
Apr 30, 2027
Completion
May 1, 2031

Study Design

Enrollment
930 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SMBP-pharmacist
    Self-measured blood pressure with clinical pharmacist support
  • No Intervention: SMBP-conventional
    Self-measured blood pressure with conventional clinical support

Primary Outcome Measure

Systolic blood pressure [ Time Frame: Baseline and 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Korey Kennelty, PharmD, PhD
319-335-8862
University of Iowa Health CareIowa CityIowa52242-

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