ASPIRE: Adapting Self-Blood Pressure Monitoring to Reduce Health Disparities

NCT06175793 | Completed

• 2 other identifiers: IRB0010481822.075E
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to implement a pilot focusing on developing training manuals and materials for patients and the clinical team to ensure our intervention is delivered consistently and systematically for each patient.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• SMBP Feasibility

  Feasibility of study methods will be evaluated using EHR data and returned SMBP logs and will include recruitment rates following patient's hypertension visits and loss to follow up rate over the 1 month follow up period.

  1 month

Secondary Outcomes (4)

• Change in systolic blood pressure (SBP)

  3 months

• Change in diastolic blood pressure (DBP)

  3 months

• Blood pressure control

  3 months

• Medication intensification

  3 months

Other Outcomes (2)

• Patient and Care Team Acceptability

  1 month

• Patients and Care Team Satisfaction

  1 month

Study Arms (2)

ASPIRE Intervention Arm

EXPERIMENTAL

The intervention arm will receive usual care, a free blood pressure cuff in addition to the ASPIRE Components.

Behavioral: ASPIRE Intervention

Control Arm

NO INTERVENTION

The control group will receive usual care and a free blood pressure cuff.

Interventions

ASPIRE Intervention BEHAVIORAL

In addition to usual care and a free blood pressure cuff, participants in the intervention arm will receive the ASPIRE components: (1) ASPIRE Tool Kit, (2) ASPIRE Coach, (3) SMBP EHR Documentation, and (4) screening and addressing SDOHs.

ASPIRE Intervention Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>=18 years old
• At least a 1-year history of hypertension
• Must have at least one clinic visit during the study recruitment period (qualifying visit)
• An elevated blood pressure value during their qualifying visit (defined as SBP above 140mm/Hg or DBP above 90mm/Hg)
• Must be on at least one blood pressure lowering medication
• Able to provide consent

You may not qualify if:

• Patients residing in a nursing home or receiving home health care
• Patients that don't speak English
• Providers:

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

ADMG Oak Lawn IM Clinci

Oak Lawn, Illinois, 60453, United States

Location

Related Publications (2)

• Khatib R, Glowacki N, Guzman I, Ozoani O, Brill J, Lauffenburger JC, Biskis A, Gordon M. Adopting Self-Measured Blood Pressure Monitoring Among Underserved Communities (ASPIRE): A Pilot Randomized Controlled Trial. J Gen Intern Med. 2025 Dec;40(16):3822-3830. doi: 10.1007/s11606-025-09646-9. Epub 2025 Jun 25.

  PMID: 40562882 DERIVED

• Khatib R, Glowacki N, Guzman I, Shields M, Chase J, Gordon M. Adapting self-measured blood pressure monitoring to reduce health disparities (ASPIRE): a pilot hybrid effectiveness-implementation study protocol. Pilot Feasibility Stud. 2025 Jan 15;11(1):7. doi: 10.1186/s40814-024-01588-z.

  PMID: 39815379 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rasha Khatib, PhD

  Advocate Aurora Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 19, 2023
• Study Start: January 15, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: April 11, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)