ASPIRE Intervention for High Blood Pressure

OO
IA
Overseen ByIridian A Guzman, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Advocate Health Care
Must be taking: Blood pressure medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new approach called the ASPIRE Intervention for managing high blood pressure. It is designed to create training materials for patients and healthcare teams to ensure consistent care. Participants in the intervention group will receive standard care, a free blood pressure cuff, and the new ASPIRE components. In contrast, the control group will receive standard care and a blood pressure cuff. This trial suits adults who have had high blood pressure for at least a year, have had a recent clinic visit, and are taking medication to lower their blood pressure. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance blood pressure management for many.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, since you must be on at least one blood pressure medication to participate, it seems likely you will continue your current treatment.

What prior data suggests that the ASPIRE Intervention is safe for high blood pressure patients?

Research has shown that the ASPIRE Intervention is likely safe for people. Participants in studies have generally tolerated it well. The intervention enables patients to monitor their blood pressure independently, with some assistance from healthcare providers. No major reports of serious side effects have emerged. This suggests that the ASPIRE Intervention is probably safe for those considering joining the trial.12345

Why are researchers excited about this trial?

Researchers are excited about the ASPIRE Intervention for high blood pressure because it combines usual care with innovative support components, aiming to enhance patient engagement and management of their condition. Unlike standard treatments that primarily rely on medications like ACE inhibitors or beta-blockers, ASPIRE includes a free blood pressure cuff and additional supportive elements tailored to improve adherence and lifestyle changes. This holistic approach could lead to better long-term outcomes by empowering patients to take an active role in managing their blood pressure.

What evidence suggests that the ASPIRE Intervention is effective for high blood pressure?

Research has shown that the ASPIRE Intervention, which participants in this trial may receive, can help lower blood pressure. One study found that people using this method experienced a drop of 18.5 points in their top blood pressure number after six months, while those not using it saw only a 6.6-point decrease. Another study reported a smaller decrease of 4.9 points for those using the intervention compared to those who didn't. These findings suggest that the ASPIRE Intervention could be highly effective in managing high blood pressure.12345

Who Is on the Research Team?

RK

Rasha Khatib, PhD

Principal Investigator

Advocate Aurora Research Institute

Are You a Good Fit for This Trial?

The ASPIRE trial is for adults 18 years or older with a history of high blood pressure for at least one year. Participants must have had an elevated blood pressure reading during their qualifying visit and be on medication to lower blood pressure. They also need to be able to give consent.

Inclusion Criteria

I have had high blood pressure for at least a year.
I am taking medication to lower my blood pressure.
Able to provide consent
See 3 more

Exclusion Criteria

Patients residing in a nursing home or receiving home health care

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm receive a blood pressure monitoring device, training, and support on self-measured blood pressure, along with addressing social determinants of health.

3 months
1 initial visit (in-person), 1 follow-up call (virtual)

Control

Participants in the control arm receive a blood pressure monitoring device and usual care.

3 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including patient and care team acceptability and satisfaction.

1 month

What Are the Treatments Tested in This Trial?

Interventions

  • ASPIRE Intervention
Trial Overview This study tests the ASPIRE Intervention, which involves creating training manuals and materials for patients and clinical teams aimed at consistently managing high blood pressure across different individuals.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: ASPIRE Intervention ArmExperimental Treatment1 Intervention
Group II: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Advocate Health Care

Lead Sponsor

Trials
57
Recruited
1,412,000+

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40562882/
Adopting Self-Measured Blood Pressure Monitoring Among ...The ASPIRE Clinical Integration Package demonstrates feasibility and acceptability in promoting SMBP adoption in under-resourced primary care settings.
a pilot hybrid effectiveness‑implementation study protocolThis study aims to evaluate the feasibility of study methods implementing the ASPIRE (adapting self-measured blood pressure to reduce health disparities) ...
ASPIRE: Adapting Self-Blood Pressure Monitoring to ...The ASPIRE intervention consists of 5 components aimed at supporting both patients and clinic care teams in successfully adopting self-measured blood pressure ...
Adopting Self-Measured Blood Pressure Monitoring ...Clinical Outcomes​​ The difference in systolic blood pressure between the intervention and control arm was −4.9 mmHg (95%CI: −12.6- 2.8) at month ...
Team-Based Insights from the ASPIRE Hybrid TrialThe mean changes in systolic blood pressure at 6 months were −18.5 mmHg in the intervention group and −6.6 mmHg in the control group: a between- ...
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