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| ID | Type | Description | Link |
|---|---|---|---|
| 22.075E | Other Identifier | Advocate HC IRB |
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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.
Barriers to blood pressure control are multi-faceted and a silver-bullet solution/intervention does not exist. Therefore, the literature highlights the importance of creating multi-component interventions when addressing blood pressure control. The ASPIRE intervention consists of 5 components identified based on the study team's prior work and review of the literature.
Patients randomized to the intervention arm will receive all 5 components of the ASPIRE intervention. Patients randomized to the control arm will receive only the first component of the ASPIRE intervention and will continue to receive usual care. The ASPIRE intervention consists of 5 components aimed at supporting both patients and clinic care teams in successfully adopting self-measured blood pressure (SMBP) into their clinic workflow.
The 5 ASPIRE components are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASPIRE Intervention Arm | Experimental | The intervention arm will receive usual care, a free blood pressure cuff in addition to the ASPIRE Components. |
|
| Control Arm | No Intervention | The control group will receive usual care and a free blood pressure cuff. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic blood pressure (SBP) | difference in the mean change in SBP (mmHg) between the intervention and control arms | 3 months |
| Change in diastolic blood pressure (DBP) | difference in the mean change in DBP (mmHg) between the intervention and control arms |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Care Team Acceptability | Patient and care team acceptability of the research methods and ASPIRE components will be evaluated based on in-depth interviews. | 1 month |
| Patients and Care Team Satisfaction |
Patients:
Inclusion Criteria:
Exclusion Criteria:
Providers:
Inclusion Criteria: Care team members who participate in the study clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Rasha Khatib, PhD | Advocate Aurora Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ADMG Oak Lawn IM Clinci | Oak Lawn | Illinois | 60453 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41919372 | Derived | Khatib R, Shields M, Ozoani O, Guzman I, Glowacki N, Ross KM, Mora N, Lauffenburger JC, Gordon M. Feasibility of Implementing a Clinical Integration Package to Support Self-Measured Blood Pressure Monitoring in Primary Care: A Qualitative Study. Circ Popul Health Outcomes. 2026 May;19(5):e012252. doi: 10.1161/CIRCOUTCOMES.125.012252. Epub 2026 Apr 1. | |
| 40562882 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 3 months |
| Blood pressure control | proportion of patients with controlled blood pressure (mmHg) | 3 months |
| Medication intensification | proportion of patients who had a medication intensification. | 3 months |
Patient and care team satisfaction with the research methods and ASPIRE components will be evaluated based on in-depth interviews.
| 1 month |
| 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. |
| 39815379 | 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. |