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

NCT06932029 | Recruiting

• 2 other identifiers: 202407611HMC-2023C2-33427
• Study Type: interventional
• Target: 930
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure

  Change in systolic blood pressure

  Baseline and 12 months

Secondary Outcomes (1)

• Multimorbidity Treatment Burden Questionnaire

  Baseline and 12 months

Study Arms (2)

SMBP-pharmacist

EXPERIMENTAL

Self-measured blood pressure with clinical pharmacist support

Behavioral: SMBP with clinical pharmacist support

SMBP-conventional

NO INTERVENTION

Self-measured blood pressure with conventional clinical support

Interventions

SMBP with clinical pharmacist support BEHAVIORAL

Self-measured blood pressure with clinical pharmacist support

SMBP-pharmacist

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• The patient is at least 65 years of age
• Patient is seen at least once in clinic or healthcare system in the previous 12 months
• Patient has a six-month average (non-acute/maintenance) systolic blood pressure (SBP) \>= 145 mmHg, documented in the electronic medical record in last six months
• Patient has a baseline in-clinic visit systolic blood pressure (SBP) \>= 140 mmHg
• Patient plants to receive care from participating healthcare system for the next 24 months

You may not qualify if:

• The patient is enrolled in hospice or has an active referral to hospice care
• The patient resides in a nursing home, in skilled nursing, rehabilitation facility, or memory care
• The patient is not capable of providing informed consent
• The patient is unable to communicate in English or Spanish
• The patient is in active chemotherapy or radiation treatment for cancer
• The patient is pregnant or has plans to become pregnant
• The patient is currently participating in another study focused on blood pressure
• The patient does not have a telephone

Sponsors & Collaborators

• Korey Kennelty: lead

Study Sites (2)

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Korey Kennelty, PharmD, PhD

CONTACT

319-335-8862; korey-kennelty@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2031
• Last Updated: October 15, 2025

Record last verified: 2025-10

Locations

US (2)