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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence

NCT04585594

Hypertension Medication Adherence

COMPLETED NA

Way to Health, Healthy Measures

NCT01282957

Diabetes Hypertension

COMPLETED NA

The Smart Hypertension Control Study

NCT03288142

Hypertension

COMPLETED NA

Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program

NCT00786162

Blood Pressure

COMPLETED NA

The Feasibility of a Web-based Application to Monitor Home Blood Pressure

NCT03116815

Hypertension

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. Access to cuff (Patient). Patients in the intervention arm and control arm will be measured for and will receive a blood pressure monitoring device to take home and keep beyond the study timeline.
2. Training (Patient). Only patients in the intervention arm will receive training and support on how to accurately measure their blood pressure. They will receive a folder containing an infographic that demonstrates how to accurately measure blood pressure at home. They will also receive a lifestyle infographic describing what they can do to improve their blood pressure.
3. Clear instructions (Patient). Patients in the intervention arm will also receive clear instructions on how to keep a record of their home blood pressure measures and share with their care team. They will be provided with a 7-day blood pressure long that details the number of blood pressure values they need to take in the mornings and evenings for seven days. Additionally, a clinic care team member serving as the ASPIRE coach will follow up with the intervention patients via a scheduled virtual call one week after they receive their materials (blood pressure monitoring device, infographics, and 7-day blood pressure log) to provide further support and instructions on self-measured blood pressure and to emphasize the importance of returning the blood pressure values to their care team.
4. SMBP EHR Documentation (ASPIRE Coach). To facilitate documentation of home blood pressure values in the electronic health record (EHR), the ASPIRE coach will average the blood pressure values patients return and document that average in the EHR. These home blood pressure averages will be shared with the patient's doctor who can use these values to modify treatment as appropriate.
5. Address Social Determinants of Health (Patient). Patients will be screened for social needs via a social determinants of health (SDOH) questionnaire that they will be asked to return to the care team. During the one week follow up virtual call the ASPIRE coach will address any identified social needs by following up with referrals as needed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ASPIRE Intervention Arm

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

Group Type EXPERIMENTAL

ASPIRE Intervention

Intervention Type 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.

Control Arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ASPIRE Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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